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SOGC
CLINICAL
PRACTICE
GUIDELINES
No. 143 – Part 1 of 3, February 2004
CANADIAN CONTRACEPTION CONSENSUS
PRINCIPAL AUTHORS
CONTRIBUTING AUTHORS
Amanda Black, MD, FRCSC, Ottawa ON
Diane Francoeur, MD, FRCSC, Montréal QC
Timothy Rowe, MB, FRCSC,Vancouver BC
John Collins, MD, FRCSC, Mahone Bay NS
Dianne Miller, MD, FRCSC,Vancouver BC
PROJECT COORDINATOR
CONTRACEPTION GUIDELINES COMMITTEE
Elke Henneberg, Communications Message & More Inc., Montréal QC
Thomas Brown, PharmD,Toronto ON
Michèle David, MD, FRCPC, Montréal QC
Sheila Dunn, MD, CCFP(EM),Toronto ON
William A. Fisher, PhD, London ON
Nathalie Fleming, MD, FRCSC, Ottawa ON
Claude A. Fortin, MD, FRCSC, Montréal QC
Edith Guilbert, MD, MSc, Quebec City QC
Louise Hanvey, BN, MHA, Chelsea QC
André Lalonde, MD, FRCSC, Ottawa ON
Ruth Miller, MEd,Toronto ON
Margaret Morris, MD, FRSCS,Winnipeg MB
Teresa O’Grady, MD, FRCSC, St. John’s NL
Helen Pymar, MD, MPH, FRCSC,Toronto ON
Thirza Smith, MD, FRCSC, Saskatoon SK
Recommendations:
Chapter 1: Introduction
1. Family planning services should be provided with dignity and
respect, based on individual differences and needs. (Grade A)
2. In order to enhance the quality of decision-making in family
planning, health-care providers should be proactive in counselling and should provide accurate information.They should be
approachable partners in a professional relationship. (Grade B)
3. Family planning counselling should include counselling on the
decline in fertility that is associated with increasing female
age. (Grade A)
4. Health-care providers should promote the use of latex condoms in combination with another method of contraception
(dual protection). (Grade B)
Chapter 2: Contraceptive Care and Access
1. Comprehensive family planning services, including abortion
services, should be freely available to all Canadians regardless
of geographic location. These services should be confidential
and respect an individual’s privacy. (Grade A)
2. Questions about sexuality should be incorporated into a general assessment. (Grade C)
3. Canadian women and men, with their health-care providers,
should address both the prevention of unintended pregnancy
and sexually transmitted infections (STIs). (Grade C)
4. Testing for STI and prevention counselling should not be
restricted to young or high-risk individuals. (Grade B)
5. Women and men should receive practical information about
a wide range of contraceptive methods so that they can
select the method most appropriate to their needs and
circumstances. (Grade C)
Abstract
Objective: To provide guidelines for health-care providers on
the use of contraceptive methods to prevent pregnancy and
sexually transmitted diseases.
Outcomes: Overall efficacy of cited contraceptive methods,
assessing reduction in pregnancy rate, risk of infection, safety,
ease of use, and side effects; the effect of cited contraceptive
methods on sexual health and general well-being; and the cost
and availability of cited contraceptive methods in Canada.
Evidence: Medline and the Cochrane Database were searched
for articles in English on subjects related to contraception,
sexuality, and sexual health from January 1988 to March 2003,
in order to update the Report of the Consensus Committee
on Contraception published in May-July 1998. Relevant
Canadian Government publications and position papers from
appropriate health and family planning organizations were also
reviewed.
Values: The quality of the evidence is rated using the criteria
described in the Report of the Canadian Task Force on the
Periodic Health Examination. Recommendations for practice
are ranked according to the method described in this Report.
Key Words
Contraception, statistics, Canada, sexuality, sexual health, hormonal
contraception, emergency contraception, barrier methods of
contraception, contraceptive sponge, female condoms, contraceptive
diaphragm, cervical cap, spermicide, fertility awareness, abstinence,
tubal ligation, vasectomy, sterilization, intrauterine devices
These guidelines reflect emerging clinical and scientific advances as of the date issued and are subject to change.The information should not be construed as
dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well
documented if modified at the local level. None of the contents may be reproduced in any form without prior written permission of SOGC.
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6. Health-care providers should assist women and men in developing the skills necessary to negotiate the use of contraception, as well as the correct and consistent use of a chosen
method of contraception. (Grade C)
7. Health promotion, emergency contraception counselling, and
the prevention of STIs, sexual violence, and cervical cancer
should be integrated into contraceptive care. (Grade C)
8. The Government of Canada should enhance access to safe
and effective products for Canadian women by accelerating
the approval process through harmonization with the therapeutic guidelines of other developed countries. (Grade C)
9. The SOGC should work with groups that support initiatives
in women’s health to promote the accessibility of all forms of
contraception in Canada. (Grade C)
10. Hormonal emergency contraception should be available without a prescription in pharmacies, family planning clinics, emergency rooms, walk-in clinics, and school health programs.
(Grade B)
11. The Society of Obstetricians and Gynaecologists of Canada
should continue the Contraception Awareness Project (CAP)
to promote safer sex and effective contraception for Canadian
women and men and to continue professional education for
health-care providers who are active in this field. (Grade C)
12. The established program, which allows compassionate provision of oral contraceptives to patients in need in Canada,
must be maintained. (Grade B)
Chapter 3: Emergency Contraception
1. Because the efficacy of hormonal emergency contraception
may be higher if used sooner, it should be started as soon as
possible after an act of unprotected intercourse. (Grade A)
2. Hormonal emergency contraception should be available without a prescription in pharmacies, family planning clinics, emergency rooms, walk-in clinics, and school health programs.
(Grade B)
3. Users of emergency contraception should be evaluated for
pregnancy if menses have not begun within 21 days following
treatment. (Grade A)
4. Women and men of reproductive age should be counselled
about emergency contraception. Women should be offered a
prescription in advance of need. (Grade B)
CHAPTER 1: INTRODUCTION
Margaret Morris, MD, FRSCS,1 Sheila Dunn, MD,
CCFP(EM),2 William A. Fisher, PhD,3 Timothy Rowe,
MB, FRCSC4
1 Winnipeg
MB
ON
3London ON
4Vancouver BC
2 Toronto
PREAMBLE
In 2003, a group of health-care professionals gathered under
the auspices of the Society of Obstetricians and Gynaecologists
of Canada to update the 1998 report of the Canadian Consensus Conference on Contraception.1 As with the original conference, the participants reviewed current information from the
perspective that family planning is an important aspect of life
and a basic human right.
The present guidelines review the statistics on contraceptive
use, give information on the determinants of contraception and
the various aspects of sexual health, describe each contraceptive
method available in Canada, and discuss the role of health-care
professionals in sexual counselling and provision of contraception. Issues affecting access to contraception are presented. The
document is designed to support professionals working in the
area of family planning, including those in family medicine,
pediatrics, gynaecology, nursing, pharmacy, and public health.
The guidelines committee met on 3 occasions, in January,
March, and May 2003. The committee was divided into 3
working groups to research, analyze, and prepare the draft of
the document. The committee developed the summary statements and recommendations based on the quality of evidence
classification scheme developed by the Canadian Task Force on
the Periodic Health Exam (Table 1). The principal authors produced the final drafts.
J Obstet Gynaecol Can 2004;26(2):143-56.
Table 1. Quality of Evidence Assessment2
Classification of Recommendations2
The quality of evidence reported in this document has been described
using the Evaluation of Evidence criteria outlined in the Report of the
Canadian Task Force on the Periodic Health Exam.
Recommendations included in this document have been adapted from
the ranking method described in the Classification of Recommendations
found in the Report of the Canadian Task Force on the Periodic Health
Exam.
A. There is good evidence to support the recommendation that the
condition be specifically considered in a periodic health exam.
B. There is fair evidence to support the recommendation that the
condition be specifically considered in a periodic health exam.
C. There is poor evidence regarding the inclusion or exclusion of the
condition in a periodic health examination, but recommendations
may be made on other grounds.
D. There is fair evidence to support the recommendation that the
condition not be considered in a periodic health examination.
I:
Evidence obtained from at least one properly randomized
controlled trial.
I-1: Evidence from well-designed controlled trials without
randomization.
II-2: Evidence from well-designed cohort (prospective or retrospective)
or case-control studies, preferably from more than one centre or
research group.
II-3: Evidence obtained from comparisons between times or places
with or without the intervention. Dramatic results in uncontrolled
experiments (such as the results of treatment with penicillin in the
1940s) could also be included in this category.
III: Opinions of respected authorities, based on clinical experience,
descriptive studies, or reports of expert committees.
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E. There is good evidence to support the recommendation that the
condition be excluded from consideration in a periodic health
examination.
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IMPACT OF FAMILY PLANNING DECISIONS
REPRODUCTIVE HEALTH
We live in an era of changing preferences for fertility control,
family size, timing of establishing a family, and choice of
occupation. The consequences of sexual risk-taking are increasingly significant. Canadians and their health-care providers are
thus involved in fertility-related decisions that will fundamentally influence individual lives and society as a whole, well into
the future. Family planning decisions affect and are influenced
by emotional health, sexual attitudes and behaviours, gender
equity, the quality of relationships, and respect between women
and men. Family planning choices made today will affect not
only the structure of the future population, but also the health,
family size, responsibilities and social opportunities, and thus
the quality of life of Canadians.
Physicians and other health-care professionals can contribute to the value of family planning decisions. Being proactive in counselling, providing accurate information, and
being approachable partners in a professional relationship built
on mutual respect, trust, open communication, and a sense of
caring will ensure that good decisions are made. Training
programs in Canada must maintain education in contraception and sexual health in their curricula, so that health-care
providers will have the necessary skills to provide care in these
areas.
TRENDS IN BIRTHS AND THERAPEUTIC ABORTIONS
Over the past 40 years there has been a dramatic decline in the
birth rate in Canadian women. The birth rate in 1997 was 44 per
1000 women aged 15 to 49, compared with 116 per 1000 women
in 1959.3 The greatest decline in birth rate occurred in the 1960s
with the introduction of a variety of birth control methods, but
statistics from the 1990s continue to show a slow decline.4 One
reason for this decline is that women are now older when they are
having children.4 In 1997 the average age of first birth was 27
years, compared to 23 years in the 1960s.5 Although birth rates
have declined dramatically in women under age 30, they have generally risen in women in their thirties over the last 15 years.5
As women delay childbearing until they are at an age when
fecundity is declining, some face difficulties in conceiving. With
increasing age, there is increased risk of aneuploidy, spontaneous
abortion, and obstetrical complications such as diabetes and
hypertension.6
Delayed childbearing is associated with an increased risk for
neonatal morbidity largely due to an increase in the birth of
preterm and low-birth-weight infants.7,8
Despite a steady decrease in the total pregnancy rate over
the last 2 decades, the adolescent pregnancy rate has remained
relatively steady. In 2000, the fertility rate for adolescents (number of pregnancies per 1000 women of reproductive age) in
Canada was 17.3, compared with 33.9 for women aged 35 to
39 and 5.9 for women aged 40 to 44.3,5
The ratio of abortions per 100 live births rose from 28.6 in
1995 to 32.2 in 2000. The highest abortion rate (number of abortions per 1000 women) in 2000 in Canada was in the 20-to-24
age group, with a rate of 31.9 per 1000 women.3,5 The persistent
use of abortion services indicates either that we are not meeting
TRENDS IN REPRODUCTIVE HEALTH AND
CONTRACEPTIVE USE IN CANADA
Reproductive health in sexually active women and men involves
the establishment of satisfying sexual relationships that are free
of unwanted pregnancy, sexually transmitted infections, violence, and coercion. The risks of these events for individuals
must be taken into account in the provision of care.
350,000
327,882
300,000
250,000
200,000
150,000
105,427
100,000
45,393
10,611
50,000
17,350
20,426
0
Births total
Abortions total
Births, ages
35-39
Abortions, ages
35-39
Figure 1. Data from Statistics Canada.3,5
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Births, ages
15-19
Abortions, ages
15-19
in the same time.15-19 Oral contraceptive use has increased, so
that it is now the contraceptive method most used in Canada;
the use of intrauterine devices has greatly declined, and the use
of condoms has increased.15-19 (Table 2)
The Canadian Community Health Survey indicated that, of
those individuals using condoms, only 41% reported always using
them.20 Among Canadians aged 15 to 19 involved in a relationship of less than 12 months, the National Population Health Survey in 1996-97 found that 16% did not use a condom during
their last intercourse, and 8% reported never using a condom.18
High-risk sexual behaviours occur across the age spectrum; of the
survey population aged 15 to 49, 8% reported never using condoms, and 16% reported not using condoms at the last intercourse in a relationship of less than 12 months.21 Alcohol use
poses a significant barrier to effective contraceptive use at all ages.
Very frequently we approach contraceptive practice with a
focus only on preventing pregnancy rather than on family planning. Assisting women to explore their plans for childbearing
is an important part of family planning and contraceptive care.
For a woman who wishes to have children in the future, contraceptive counselling includes providing specific information
about how fertility declines with age (Table 3), so that she can
make an informed choice about family planning.
the contraceptive needs of Canadian women, or that different
approaches to the provision of contraception are required.
Relevant data from Statistics Canada in 2000 are shown
in Figure 1.
TRENDS IN INCIDENCE OF SEXUALLY
TRANSMITTED INFECTIONS
From January to December 2002, Statistics Canada reported
56 093 cases of chlamydia infection and 7195 cases of gonorrhea.9 The highest risk for contracting chlamydia infection and
gonorrhea is in 15 to 19 year olds.10 The 1998, age-specific incidence of hepatitis B remains highest among 25 to 29 year olds,
with a male to female ratio of 5:2. The incidence of hepatitis
B has continued to gradually decline with time.11
The number of positive human immunodeficiency virus
(HIV) tests declined steadily in the late 1990s, although at the
same time the number of positive HIV tests reported among
heterosexuals increased. In 1999, 4190 Canadians were newly
infected with HIV, similar to the number of newly reported
cases in 1996. The cumulative total of HIV-positive tests reported in Canada up to June 2000 was 46 651.12
TRENDS IN DOMESTIC VIOLENCE
Effective use of a contraceptive method is difficult in situations
where one partner is being victimized. Pregnancy is associated
with both initiation and exacerbation of domestic violence, so
contraceptive failure carries added risk for women in abusive or
potentially abusive relationships.13 In Canada, the rate of
spousal (including common-law partner) violence directed
against women was reported in 1999 as 8%, a decline from the
rate of 12% reported in 1993. 14 However, in Aboriginal
women, the reported rate of spousal violence in 1999 was 20%,
compared to the reported rate of spousal violence in nonAboriginal women of 7%.14
MAJOR DETERMINANTS OF CONTRACEPTIVE CHOICE
An understanding of the social and psychological factors that
drive contraceptive choice is essential for the creation of effective clinical and educational interventions to promote reproductive health in this area.23-26 Three activities, described here,
appear to influence contraceptive use and other reproductive
health behaviours significantly.27 In order to become an effective health-care professional and to be involved in shared contraceptive decision-making, clinicians should:
• share information
• enhance motivation, and
• help to develop behavioural skills
First, information about contraception and sexuality that is
easy for the individual to understand and easy for the individual to act on is a prerequisite for contraceptive use.27-29
Information is easily exchanged verbally, or through
brochures and other demonstration materials. This information,
in order to be useful, needs to be:
CONTRACEPTIVE USE
Canadian contraceptive use has changed over the past 20 years.
Reliance on female sterilization has shown a linear decline across
the past decade, while rates of male sterilization have stabilized
Table 2. Methods of Birth Control Currently Used
By Women Who Have Had Intercourse19
Method
%
Oral contraceptives
Condom
Sterilization, male
Sterilization, female
Withdrawal
Injection (DMPA*)
Intrauterine device
Rhythm
32
Table 3. Effect Of Age On Fertility 22
21
15
8
6
2
1
2
Age When Beginning
Attempts to Conceive
20–24
25–29
30–34
35–39
40–44
*DMPA: depot-medroxyprogesterone acetate
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% of Women
Remaining Childless
6
9
15
30
64
• easy to understand (common words, simple instructions
written in conversational fashion, information connected with individual social and sexual behaviour patterns)
• attractive and tailored to individual needs (question-andanswer format on particular topics, humorous anecdotes,
pictures, and graphs)
• timely and accessible (available for the individual in time
for it to be used effectively, and in a place that is comfortable for accessing the information)
Second, motivation to use contraception is a critical determinant of whether even well-informed individuals will act on
what they know, and therefore use contraception effectively.30-32
Motivation will be affected by
• personal attitudes about the use of contraception
(“What do you think of this contraceptive method
and its use?”)
• social norms that are seen to support or to oppose contraceptive use (“What will people around you think of
you using this contraceptive method?”)
• personal factors modifying effective contraceptive use
(“What could make you use your contraceptive method
less effectively? What could you do to overcome these
difficulties?”)
• perceived vulnerability to, and perceived costs of,
unwanted pregnancy (“How would you react if you got
pregnant now? When do you want to get pregnant? Do
you think you could get pregnant before you want to?”)
Third, behavioural skills for using contraception are crucial
determinants of whether even a well-informed and well-motivated person will be capable of using contraception effectively
over the long term.30,33
Contraceptive use requires an individual to perform a complicated series of intrapersonal and interpersonal acts that are
rarely, if ever, directly taught or discussed. In order to be an
effective user of contraception, an individual must be able to
acquire and understand contraceptive information, anticipate
sexual intercourse, talk with a partner about contraception,
engage in such public acts as visiting a physician or a pharmacy
to obtain contraception, and use contraception correctly and
consistently over the long term.
Clinicians and educators need to be aware of the behavioural complexity of contraceptive use. They need to share,
counsel, coach, teach, and problem solve so that individuals will
be aware of their contraceptive behavior, be prepared to enact
each of its steps skillfully, and be able to solve problems should
the need arise. Strategies to reduce harm, including the concept
of “dual protection” to reduce the risk of both unplanned pregnancy and sexually transmitted infection (STI), need to be
addressed with each encounter.
The Society of Obstetricians and Gynaecologists of Canada
provides easily accessible resources on contraception and sexual
health:
JOGC
• www.sexualityandu.ca (for health-care providers, educators, parents and consumers)
• www.sogc.org (for health-care providers to access clinical practice guidelines, has a contraception hotline, and
lists answers to frequently asked questions)
• Sex Sense (an award-winning consumers’ guide to contraception and sexuality in paperback form)
SUMMARY STATEMENTS
1. Family planning is an important aspect of life and is a basic
human right. Canadians have the right to the highest possible quality care related to their sexual and reproductive health
as part of primary health care.
2. Both adults and adolescents face challenges when attempting to use contraception appropriately and consistently.
3. The provision of appropriate contraceptive services requires
adequate training of care providers in the areas of contraception and sexual health. (Level II-2)
4. The consistent and correct use of latex condoms in combination with another method of contraception (dual protection) will provide maximal protection against unintended
pregnancy and STI, including HIV infection. (Level III)
RECOMMENDATIONS
1.Family planning services should be provided with dignity and respect, based on individual differences and
needs. (Grade A)
2.In order to enhance the quality of decision-making in
family planning, health-care providers should be proactive in counselling and should provide accurate information. They should be approachable partners in a
professional relationship. (Grade B)
3.Family planning counselling should include counselling
on the decline in fertility that is associated with increasing female age. (Grade A)
4.Health-care providers should promote the use of latex
condoms in combination with another method of
contraception (dual protection). (Grade B)
REFERENCES
1. The Society of Obstetricians and Gynaecologists of Canada.The Canadian Consensus Conference on Contraception. J Soc Obstet Gynaecol
Can 1998;20: 482-9, 571-98,667-92
2. Woolf SH, Battista RN,Angerson GM, Logan AG, Eel W. Canadian Task
Force on the Periodic Health Exam. Ottawa: Canada Communications
Group; 1994. p. xxxvii.
3. Statistics Canada.Women in Canada 2000: a gender-based statistical
report. Ottawa: Minister of Industry; 2000. p. 34.
4. Statistics Canada.Age-specific fertility rate. Ottawa: Health Statistics
Division, 2000. Catalogue No.82F0075XCB
5. Statistics Canada. Births: shelf tables. Ottawa: Health Statistics Division,
2000. Catalogue No. 84F0210XPB.
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FEBRUARY 2004
6. ASRM Practice Committee. Aging and infertility in women. Fertil Steril
2002;78:215–19.
7. Tough SC, Newburn-Cook C, Johnston DW, Svenson LW, Rose S, Belik
J. Delayed childbearing and its impact on population rate changes in
lower birth weight, multiple birth and preterm delivery. Pediatrics
2002;109:399–403.
8. Dollberg S, Seidman DS,Armon Y, Stevenson DK, Gale R.Adverse perinatal outcome in the older primipara. J Perinatol 1996; 6:93–7.
9. Health Canada, Population and Public Health Branch. Reported cases
and rates of notifiable STI from January 1 to December 31, 2002 and
January 1 to December 31, 2001.Available on-line at http://www.hc-sc.
gc.ca/pphb-dgspsp/std-mts/stdcases-casmts/index.html Web site updated August 8, 2003.Accessed December 9, 2003.
10. Health Canada, Population and Public Health Branch. Canada communicable disease report: CCDR suppl.Vol 26S6 October 2000,Appendix 1:1A.
11. Health Canada, Population and Public Health Branch, Division of Immunization and Respiratory Diseases.Vaccine preventable diseases: hepatitis B. Data from the CIDPC National Notifiable Diseases Registry
System (NNDRS).Available on-line at http://www.hc-sc.gc.ca/pphbdgspsp/dird-dimr/vpd-mev/hepatitis-b_e.html.Web site updated
October 23, 2002.Accessed December 9, 2003.
12. Health Canada, Division of HIV/AIDS Epidemiology and Surveillance,
Centre for Infectious Disease Prevention and Control, Population and
Public Health Branch. HIV and AIDS in Canada. Surveillance Report to
Dec. 31/02.Available on-line at <http://www.hc-sc.gc.ca/pphbdgspsp/publicat/aids-sida/>.Web site updated July 31, 2003.Accessed
December 9, 2003.
13. Mayer L, Liebschutz J. Domestic violence in the pregnant patient: obstetric and behavioral interventions. Obstet Gynecol Surv 1998;53:627–35.
14. Statistics Canada. Family violence in Canada: a statistical profile. Ottawa:
Canadian Centre for Justice Statistics; 2003. Catalogue No. 85-224-XIE.
15. Balakrishnan TR, Krotki K, Lapierre-Adamcyk E. Contraceptive Use in
Canada, 1984. Fam Plann Perspect 1985;17:209–15.
16. Boroditsky R, Fisher W, Sand M.The Canadian contraception study. J
Soc Obstet Gynaecol Can 1995;17:1–28.
17. Boroditsky R, Fisher W, Sand M.The 1995 Canadian Contraceptive
Study. J Soc Obstet Gynaecol Can 1996;18:1–31.
18. Fisher WA, Boroditsky R, Bridges ML.The 1998 Canadian contraception
study. Can J Hum Sex 1999;8:161–216.
19. Fisher WA, Boroditsky R, Morris B.The 2002 Canadian Contraception
Study. JOGC Manuscript submitted for publication.
20. Statistics Canada. National Population Health Survey data file-Custom
tabulations. Ottawa: Statistics Canada; 1999. Catalogue No. 82C0013.
21. Statistics Canada. Statistical Report on the Health of Canadians,
Ottawa: Statistics Canada; 1999. Catalogue No. 82-570-XIE.
22. Menken J,Trussell J, Larsen U.Age and infertility. Science
1986;233:1389–94.
23. Health Canada, Minister of Health, Community Acquired Infections
Division. Canadian guidelines for sexual health education 2003. Ottawa:
Health Canada; 2003.
24. Byrne D, Kelley K, Fisher WA. Unwanted teenage pregnancies:
incidence, interpretation, intervention.Appl Prev Psych 1993;2:101–13.
25. Fisher JD, Fisher WA. Changing AIDS-risk behaviour. Psych Bull
1992;111:455–74.
26. Fisher WA.All together now: an integrated approach to preventing adolescent pregnancy and STD/HIV infection. Siecus Report 1990;18:1–11.
27. Fisher,WA, Fisher, JD.The information-motivation-behavioral skills
model: a general social psychological approach to understanding and
promoting health behavior. In: Suls J,Wallston KA, editors. Social
psychological foundations of health and illness. Malden, Massachusetts:
Blackwell; 2003. p. 82–106.
28. Rosenberg M,Waugh MS. Causes and consequences of oral contraceptive noncompliance.Am J Obstet Gynecol 1999;180:276–9.
29. Rosenberg MJ,Waugh MS, Burnhill MS. Compliance, counseling and satisfaction with oral contraceptives: a prospective evaluation. Fam Plann
Perspect 1998;30:89–92.
30. Byrne D, Fisher WA, editors.Adolescents, sex, and contraception. Hillsdale, NJ: Lawrence Erlbaum Associates; 1983.
JOGC
31. Fisher WA, Byrne D, Kelley K,White LA. Erotophobia-erotophilia as a
dimension of personality. J Sex Res 1988;25: 123–51.
32. Fisher WA, Fisher JD, Rye BJ. Understanding and promoting AIDS preventive behavior: insights from the theory of reasoned action. Health
Psych 1995;14:255–64.
33. Fisher WA, Fisher JD. Understanding and promoting sexual and reproductive health behavior: theory and method. Ann Rev Sex Res
1999;9:39–76.
CHAPTER 2: CONTRACEPTIVE CARE AND ACCESS
William A. Fisher, PhD,1 Sheila Dunn, MD, CCFP(EM),2
André Lalonde, MD, FRCSC3
1London
ON
ON
3Ottawa ON
2Toronto
INTRODUCTION
The World Health Organization recognizes reproductive and sexual health care as a fundamental human right.1 The Platform for
Action of the 1995 Beijing Conference affirms the following:
… the basic right of all couples and individuals to decide
freely and responsibly the number and spacing and timing of
their children and to have the information and means to do
so, and the right to attain the highest standard of sexual and
reproductive health.2
Responsibility for ensuring these rights lies with government,
the health-care system, and individual health-care providers.
Specifically, governments must make safe and effective contraceptive methods available and accessible, and provide adequate
funding for delivery of contraceptive and sexual health services.
The health-care system must ensure that contraceptive and sexual health services meet the needs of the population. Finally, individual health-care providers must recognize contraceptive care as
more than just the provision of a method of birth control. Healthcare providers should not only ensure that individuals have information and access to the widest array of safe and effective methods
of birth control, but also take into account their broader sexual
and reproductive health-care needs in helping them to choose
and use a contraceptive method. Those who actively collaborate
in choosing a contraceptive are most likely to be satisfied with
their method and are most likely to adhere to it over time.3
CONTRACEPTIVE CARE IN THE CONTEXT OF SEXUAL
BEHAVIOR AND REPRODUCTIVE HEALTH
Choosing a contraceptive method, and having the desire and
ability to take up and continue to use contraception (contraceptive adherence) take place in the broader context of a person’s
social circumstances, belief system, sexual behavior, and reproductive health needs. An integrated approach to contraceptive
care that recognizes the relationship of these factors is therefore
recommended in order to address their sexual health needs.4
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and an agreeable partner are also critical to a person’s ability to
use contraception effectively (Figure 1). Well-informed, wellmotivated, and behaviourally skilled individuals in a supportive
environment are the most likely to take up and adhere to effective and safe contraception.5,6
Information that is practical and relevant to contraceptive
choice is central to a person’s ability to adopt a contraceptive
method that meets her needs. Canadians have a limited awareness of their contraceptive options, and have suboptimal adherence to contraceptive methods.7 Health-care providers can help
to address these challenges to effective contraceptive practice by
providing information about
• the range of birth control options and their effectiveness
• specific characteristics of the method
• common side effects
• health risks and benefits
• how to use a chosen method correctly
• what to do if problems occur
CONTRACEPTIVE EFFECTIVENESS
A major factor influencing choice of a contraceptive method is
the effectiveness of the method in preventing pregnancy. This
is related to both the inherent efficacy of the method and how
consistently and correctly it is used. Some methods such as sterilization are inherently very effective and are almost unaffected
by user characteristics. Others, such as condoms, are inherently effective but in actual use are very dependent on the user for
achieving their maximal effectiveness (Table 1). Health-care
providers should address these differences in counselling.
INDIVIDUAL AND ENVIRONMENTAL DETERMINANTS
OF CONTRACEPTIVE BEHAVIOR
An individual’s knowledge about contraception, their motivation
to act on this knowledge, and their ability to act on it effectively
will influence contraceptive choice and adherence to a contraceptive method over time. Supportive environmental factors
such as ready access to health care, affordable contraception,
Table 1. Effectiveness of Family Planning Methods*
Pregnancies per 100 women in first
12 months of use
As commonly
used
Used correctly
and consistently
0.2
0.3
0.5
0.8
1
0.1
0.3
0.5
0.6
0.5
2
6-8
0.5
0.1
Progestin-only oral contraceptives
(not during breastfeeding)
†
0.5‡
Male condoms
Coitus interruptus‡
Diaphragm with spermicide
Fertility awareness-based methods
Female condoms
Spermicides
Cervical Cap
Nulliparous women
14
19
20
20
21
26
3
4
6
1-9
5
6
20
-----------------------
9
40
26
85
85
Effectiveness group
Family planning method
Vasectomy
DMPA
Female sterilization
Cu-380 IUD (no longer available in Canada)
Always very
effective
Progestin-only oral contraceptives (during
breastfeeding)
Effective as
commonly used;
very effective when
used correctly and
consistently
Only somewhat
effective as
commonly used;
effective when used
correctly and
consistently
Lactational amenorrhea method
Combined oral contraceptives
Parous women
No Method
*Adapted from: World Health Organization. Medical eligibility criteria for contraceptive use. Geneva, World Health Organization, 2000; Hatcher
RA, Rinehart W, Blackburn R, Geller JS, Shelton JD. The essentials of contraceptive technology. Baltimore, Johns Hopkins University School of
Public Health, Population Information Program; 1997.
†Outside breastfeeding, progestin-only contraceptives are somewhat less effective than combined OCs. See Hatcher RA, Trussell J, Stewart F,
Cates Jr W, Stewart GK, Buest F, et al. Contraceptive technology. 17th ed. New York; Ardent Media Inc.; 1998.
‡Hatcher RA, Trussell J, Stewart F, Cates Jr W, Stewart GK, Buest F, et al. Contraceptive technology. 17th ed. New York: Ardent Media Inc.; 1998.
Key
0-1
Very effective
2-9
Effective
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Somewhat effective
• strategies to assist an individual’s or couple’s consistent
use of a method over time
• back-up strategies such as emergency contraception
• information on avoiding sexually transmitted infection8-10
In order to provide information that is meaningful and relevant to an individual’s needs and lifestyle, health-care providers
must elicit information about their sexual activity, family planning intentions, and personal preferences. Such a two-way flow
of contraceptive information is essential to achieving an optimal user-method “fit” that will promote appropriate choice, satisfaction, and adherence.
Motivation is a second critical determinant of effective contraceptive use. Personal motivation (attitudes towards specific
contraceptive practices) strongly influences contraceptive choice.
Anyone who has negative attitudes about contraception, or is
uncomfortable with their sexuality, is unlikely to anticipate the
need for contraception in advance.8 They are also unlikely to
be able to discuss this matter preemptively with their partner or
with their physician, or to adhere to a contraceptive regimen
consistently over time.11-13 A person’s social norms – that is,
their perceptions about what is accepted or rejected by a partner, a parent, or other significant persons – also influence contraceptive choice and adherence.11-13 By considering the
characteristics of a range of contraceptive methods, individuals
can tailor the method they choose to their own attitudes and
set of social expectations.
Specific behavioural skills are needed to acquire a contraceptive and use it correctly and consistently.4,11 The individual must
first acknowledge the fact that he or she is (or soon will be) sexually active. Individuals must then formulate a contraceptive
health agenda; this may involve acquiring and using a method
of birth control, practising safer sex, and seeking reproductive
health care such as regular cervical cancer screening. Once this
agenda is set, the individual must actively seek information
about contraception and related reproductive health issues,
choose and obtain a method of contraception, negotiate its use
with a partner, and use it correctly and consistently over time.
Contraception is a complex matter involving a number of
tasks. Awareness of this on the part of health-care providers is
the first step in assisting consumers to develop the behavioural
Information
Motivation
Behavioural
Skills
skills required. Health-care providers should review with individuals how they can use these skills in situations when sexual
activity is likely. For example, practising how to bring up condom use with a partner can help build the behavioural skills
essential for practising safer sex. (“Tell him you want to have
sex, and that he should put on a condom.”) Simple information about routines (“A lot of my patients take their pill every
morning when they brush their teeth, and I give all of my
patients a prescription for the ‘morning after pill,’ just in case.”)
can build an individual’s confidence in their method and their
ability to use it effectively.
Environmental factors may lessen the ability of even wellmotivated individuals to use contraception effectively.8 Those
who are in abusive or disempowered relationships, who cannot
afford contraception, who have limited access to care, who are
chemically dependent, and who have major competing life
demands are unlikely to use contraception effectively, unless
such environmental factors are addressed.8
The assessment and discussion of environmental barriers to
contraceptive choice (e.g., cost) or adherence (e.g., chemical
dependency) are an important part of contraceptive counselling.
For example, if a woman’s environment requires an “invisible”
method of contraception, injections of long-acting progestin or
use of an intrauterine device with the strings cut short may represent a good user-method “fit.” Cost issues can often be circumvented if they are determined to be impediments as well.
Finally, addressing issues such as physically abusive relationships
in which contraception is not tolerated may take precedence
over contraceptive management itself.
THE RELATIONSHIP OF CONTRACEPTIVE
PRACTICE TO SEXUAL BEHAVIOUR AND
REPRODUCTIVE HEALTH
Contraceptive choice and utilization can have direct effects on
sexual activity and reproductive health status. For example, the
provision of a non-barrier contraceptive can free a woman to
initiate sexual activity without fear of pregnancy, but at the same
time it puts her at risk of acquiring a sexually transmitted infection (STI) that can impair her fertility and overall health. The
more sexual partners that young Canadian women report
having, the more likely they are to be using oral contraception,
the less likely they are to use condoms, and the more likely they
are to have had an STI.14
Given the interdependency of contraceptive use, sexual
activity, and reproductive health, contraceptive care must
address contraception in the broader context of each of these
factors. When providing information for making a contraceptive choice appropriate to an individual’s attitudes, preferences,
and environmental constraints, health-care providers should
also counsel about related sexual health concerns such as STIs,
sexual function, relationship violence, cervical cancer screening, and hepatitis B vaccination.15 For example, a woman using
Contraceptive
Choice
Contraceptive
Adherence
Figure 1. Individual and environmental determinants of
contraceptive behavior: environmental factors.
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www.sexualityandu.ca
www.plannedparenthood.org/health/
www.itsyoursexlife.com/
www.womenshealthmatters.ca
a hormonal method of contraception who is in a new but
monogamous relationship should be advised about the need
for STI prevention, including dual protection (use of hormonal
contraception plus condoms), mutual human immunodeficiency virus (HIV) antibody testing and mutual monogamy.
REFERRAL NETWORKS
A locally relevant referral map will help in making appropriate
referrals for specialized care. This may include referral links to
abortion providers, public health services, child protection services, domestic violence services and sex therapists. In addition,
an office library with pamphlets, books, and a list of Web
resources for patient use can support practical information
needs.
PUTTING AN INTEGRATED APPROACH TO
CONTRACEPTIVE CARE INTO PRACTICE
To establish a “sexual health–friendly” environment, the following cues may be helpful.
Environmental cues such as posters, books, or brochures in
the practice setting clearly establish that the health-care
provider is an approachable and knowledgeable source for
contraceptive and reproductive health care. These cues can
encourage individuals to express contraceptive and reproductive health concerns even in visits not originally intended for
this purpose.
Verbal cues can systematically address contraception and
related sexual and reproductive health concerns. Health-care
providers can use a script-like approach during routine history
taking or sexual health–related visits. This might involve the following verbal cues from the health-care provider:
“Part of my job is to help look after your sexual and reproductive health. Do you mind if I ask a few questions in this area?
• Are you sexually active? With men, or with women, or
both?
• What are you and your partner doing to prevent pregnancy?
• What are you and your partner doing to prevent sexually
transmitted infection/HIV infection?
• Do you have any concerns or questions about sexual
function?
• Do you have any concerns or questions about sexual or
relationship violence?
You can always ask me questions about these issues.”
This approach to contraceptive care has a number of advantages. First, it can be used either in a visit for a general health
assessment, or, with appropriate modification, in a visit for contraception or a sexual health concern. Second, it integrates a discussion of contraception, sexual activity, sexual function, and
sexual or relationship violence. Third, this approach identifies
the legitimacy of care in this area, and the approachable and
non-judgemental nature of the clinician for ongoing sexual
health care.
CONTINUING EDUCATION
Knowledge in contraceptive care is frequently changing as new
contraceptive technologies become available. Training programs
for health-care professionals should include sexual health counselling. Health-care providers should assess their own skills and
comfort level, and seek out continuing clinical education in contraceptive care and related areas. The Web site www.sexualityandu.ca, administered by the Society of Obstetricians and
Gynaecologists of Canada (SOGC), contains current information for health-care providers and others. The SOGC also initiated and manages a Canada-wide Contraception Awareness
Project (CAP) to promote safer sex and effective contraception
for Canadian women and men. Information about this program is available at www.sogc.org (search for “contraception
awareness”).
ACCESS TO CONTRACEPTION
There are significant barriers to the effective use of contraception. Some of these are related to the potential user, some are
provider related, some are system related, and some are related
to government and industry.
ISSUES RELATED TO CONTRACEPTIVE USERS
The knowledge and motivation of the contraceptive user is central to effective contraceptive practice. Potential users must first
acknowledge their need for contraception. They must have
enough information about contraception to choose a method,
know how to obtain their chosen method if it is one that does
not require a prescription, and know how to use it correctly.
Alternatively, they need to know where and how to access a
health-care provider for contraceptive counselling and sexual
health assessment, so that a suitable method can be provided or
prescribed. Teens are a particularly vulnerable group in this
respect, as they are often reluctant to seek information and help
for contraception from their family physician.16 School-based
programs that provide information about contraception have
been shown to reach this target group effectively.17-18
THE HEALTH-CARE PROVIDER AS
AN INFORMATION RESOURCE
Practical information that is easy for the individual to understand and to translate into behaviour is the foundation of good
contraceptive practice. This can be done through individual
counselling, or through brochures, books, or Web sites such as:
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SUMMARY STATEMENTS
ISSUES RELATED TO PROVIDERS
Other steps to contraceptive utilization are provider dependent.
Providers must be knowledgeable about the variety of contraceptive methods available, and be able to provide them.
Providers may be less likely to recommend use of a contraceptive method with which they are not familiar, such as the
intrauterine device.
Health-care providers must also be approachable and accessible to the population in need of contraception. In times of
doctor shortages and cutbacks in the funding of sexual health
services by public health departments, there may not be a sufficient number of health-care providers to ensure that contraceptive services meet the needs of the population.
1. Sexuality is an important aspect of life and is expressed in
a variety of ways.
2. Counselling about contraception and STI consists of tailoring information to individual needs, enhancing positive
attitudes towards contraception, sexuality, and STI prevention; modifying barriers to effective use; and helping
individuals to develop practical skills to use their contraceptive method consistently. (Level II-2)
3. All individuals in sexual relationships are at risk for acquiring STIs; individuals changing or establishing new relationships are especially at risk. (Level II-2)
4. Well-informed, well-motivated, and behaviourally skilled
individuals are more likely to use safe contraceptive and STI
prevention methods effectively and consistently. (Level II-2)
5. Canadian women and men have the right to access a wide
range of contraceptive options.
SYSTEM-RELATED ISSUES
Access to a contraceptive method can be impeded if the cost
of the method is excessive, or if the delivery of the method is
cumbersome or inconvenient. The cost of many contraceptive
methods is out of reach for women with limited financial
means. Both government and private insurance plans cover the
costs of many birth control methods, but this is not uniform
even for hormonal methods. Sexual health clinics and many
university health services provide free or subsidized contraceptives but these services are not widely available to the population as a whole. The SOGC’s national Compassionate Oral
Contraceptive Program ensures that access to contraception is
not denied because of lack of funds. Information about this
program is available at www.sogc.org (search for “contraception awareness”).
RECOMMENDATIONS
1. Comprehensive family planning services, including
abortion services, should be freely available to all Canadians regardless of geographic location. These services
should be confidential and respect an individual’s privacy. (Grade A)
2. Questions about sexuality should be incorporated into
a general assessment. (Grade C)
3. Canadian women and men, with their health-care
providers, should address both the prevention of unintended pregnancy and STIs. (Grade C)
4. Testing for STI and prevention counselling should not
be restricted to young or high-risk individuals. (Grade B)
5. Women and men should receive practical information
about a wide range of contraceptive methods so that
they can select the method most appropriate to their
needs and circumstances. (Grade C)
6. Health-care providers should assist women and men in
developing the skills necessary to negotiate the use of
contraception, as well as the correct and consistent use
of a chosen method of contraception. (Grade C)
7. Health promotion, emergency contraception counselling, and the prevention of STIs, sexual violence, and
cervical cancer should be integrated into contraceptive
care. (Grade C)
8. The Government of Canada should enhance access to
safe and effective products for Canadian women by
accelerating the approval process through harmonization with the therapeutic guidelines of other developed
countries. (Grade C)
9. The SOGC should work with groups that support initiatives in women’s health to promote the accessibility
of all forms of contraception in Canada. (Grade C)
GOVERNMENT AND INDUSTRY-RELATED ISSUES
Canadian women deserve access to all safe and effective contraceptive methods. Nevertheless, contraceptive choice in
Canada is restricted in comparison to the situation in many
other countries. A comparison of the availability of new contraceptive products shows that Canadian women have access
to only 17% of the newer methods available, compared to
Denmark, where 61% of all newer products are approved, and
the United States, where 44% are approved.19 The time for
approval of new drugs in Canada is significantly longer than
in the United States and Sweden.20 In this environment, sponsors may not submit applications for new hormonal contraceptives when there appears to be a low chance of successful
approval.19
In recent years, Canadian women have lost access to products that are approved because suppliers have withdrawn them
from the Canadian market. Thus Canadian women no longer
have access to the Gyne-T 380 IUD, Norplant, and the Lea
Shield. The Canadian market is small for many of these products, and unfortunately decisions are made that are detrimental to the ability of Canadian women to choose a contraceptive
that is most acceptable to them.
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18. McKay A, Fisher WA, Maticka-Tyndale E, Barrett M. Canadian sexual
health education: does it work? can it work better? an analysis of recent
research and media reports. Can J Hum Sex 2001;10:127–35.
19. Azzarello D, Collins J, Lalonde A. Canadian access to hormonal contraceptive drug choices. J Obstet Gynecol Can 2003 (in press)
20. Rawson NS, Kaitin KI. Canadian and US drug approval times and safety
considerations. Ann Pharmacother 2003;37:1403–8.
10. Hormonal emergency contraception should be available without a prescription in pharmacies, family planning clinics, emergency rooms, walk-in clinics, and
school health programs. (Grade B)
11. The SOGC should continue the Contraception Awareness Project (CAP) to promote safer sex and effective
contraception for Canadian women and men and to
continue professional education for health-care
providers who are active in this field. (Grade C)
12. The established program, which allows compassionate
provision of oral contraceptives to patients in need in
Canada, must be maintained. (Grade B)
CHAPTER 3: EMERGENCY CONTRACEPTION
Sheila Dunn, MD, CCFP(EM),1
Edith Guilbert, MD, MSc2
1Toronto
2Quebec
ON
City QC
REFERENCES
INTRODUCTION
1. World Health Organization. Improving access to quality care in family
planning. Geneva:World Health Organization; 2000. p. 2.
2. Platform for Action and the Beijing Declaration. Fourth World Conference on Women; 4–15 September 1995. Beijing, China. New York:
United Nations Department of Public Information; 1996. p. 124.
3. Delbanco TL, Daley J.Through the patient's eyes: strategies toward more
successful contraception. Obstet Gynecol 1996;88(Suppl):41S–47S.
4. Fisher WA, Fisher JD. Understanding and promoting sexual and reproductive health behavior: theory and method.Annu Rev Sex Res
1998;9:39–76.
5. Byrne D, Kelley K, Fisher WA. Unwanted teenage pregnancies:
incidence, interpretation, intervention. Appl Prev Psych 1993;2:101–13.
6. Fisher JD, Fisher WA.Theoretical approaches to individual level change
in HIV risk behavior. In: Peteson J, DiClemente R, editors. Handbook of
HIV prevention. New York: Plenum; 2000. pp. 3–55.
7. Fisher WA, Boroditsky R, Bridges M. Canadian contraception study
1998. Can J Hum Sex 1999;8:161–220.
8. Fisher WA, Fisher JD.The information-motivation-behavioral skills
model: a general social psychological approach to understanding and
promoting health behavior. In: Suls J,Wallston KA, editors. Social
psychological foundations of health and illness. Malden, Massachusetts:
Blackwell; 2003. pp. 82–106.
9. Rosenberg M,Waugh MS. Causes and consequences of oral contraceptive noncompliance.Am J Obstet Gynecol 1999;180(2 Pt 2):276–9.
10. Rosenberg MJ,Waugh MS, Burnhill MS. Compliance, counseling and satisfaction with oral contraceptives: a prospective evaluation. Fam Plann
Perspect 1998;30:89–92.
11. Byrne D, Fisher WA, editors.Adolescents, sex, and contraception. Hillsdale, NJ: Lawrence Erlbaum Associates; 1983.
12. Fisher WA, Byrne D, Kelley K,White LA. Erotophobia-erotophilia as a
dimension of personality. J Sex Res 1988;25:123–51.
13. Fisher WA, Fisher JD, Rye BJ. Understanding and promoting AIDS preventive behavior: insights from the theory of reasoned action. Health
Psychol 1995;14:255–64.
14. Macdonald NE,Wells GA, Fisher WA,Warren WK, King MA, Doherty
JA, et al. High-risk STD/HIV behavior among college students. J Am Med
Assoc 1990;263:3155–9.
15. Laboratory Centre for Disease Control (LCDC) Expert Working
Group on Canadian Guidelines for Sexually Transmitted Disease. Canadian STD guidelines 1998 edition. Ottawa: Minister of Public Works and
Government Services Canada; 1998.
16. Fisher WA, Boroditsky R. Sexual activity, contraceptive choice, and sexual and reproductive health indicators among single Canadian women
aged 15–29: additional findings from the Canadian Contraception Study.
Can J Hum Sex 2000;9:79–93.
17. Kirby D. Emerging answers: research findings on programs to reduce
teenage pregnancy.Washington DC:The National Campaign to Prevent
Teenage Pregnancy; 2001.
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Emergency contraception (EC) is any method of contraception
which is used after intercourse and before the potential time of
implantation. As these methods work prior to implantation,
they are not abortifacients. Emergency contraception is a backup method for occasional use, and should not be used as a
regular method of birth control.
OPTIONS
There are 2 methods of emergency contraception: hormonal
methods, which involve the use of emergency contraceptive pills
(ECPs), and the post-coital insertion of a copper intrauterine
device (IUD). Two hormonal preparations are used as ECPs in
Canada: one contains only the progestin levonorgestrel, while
the other is a combined preparation containing both ethinyl
estradiol and levonorgestrel.
The levonorgestrel-only method, marketed as Plan B, was
introduced into Canada in 2000 and is the only product
approved by Health Canada for EC. The regimen consists of
2 doses of 750 µg levonorgestrel taken orally 12 hours apart.
In use since the 1970s, the Yuzpe method consists of the
oral administration of 2 doses of 100 µg ethinyl estradiol (EE)
and 500 µg levonorgestrel 12 hours apart. Ovral tablets (each
containing 50 µg ethinyl estradiol and 250 µg levonorgestrel)
are most commonly used to provide these doses. Other products can be substituted if they are more readily available
(Table 1). Although they may not deliver an exactly equivalent dose, they are considered to offer equivalent efficacy.1
EFFECTIVENESS
The Yuzpe and levonorgestrel-only methods have been shown in
randomized trials to reduce the risk of pregnancy by approximately
75 and 85% respectively.2-5 This does not mean that 25% of
women using the Yuzpe method will become pregnant; it means
that, if 100 women had unprotected intercourse once during the
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second or third week of their menstrual cycle, 8 of them would be
likely to become pregnant, but that only 2 would become pregnant (a reduction of 75%) after use of the Yuzpe method.6 A single dose of 1.5 mg of levonorgestrel appears to be as effective as
the standard 2-dose levonorgestrel regimen.7,8
Although they have generally been used only up to 72 hours
after intercourse, both hormonal methods of EC are effective
when taken between 72 and 120 hours after unprotected intercourse.7,9,10 The effectiveness when used after 72 hours seems
to be slightly lower. The effectiveness of EC has been shown to
decline significantly with increasing delay between unprotected intercourse and the initiation of treatment: levonorgestrel
EC prevented 95% of pregnancies when used within 24 hours
of intercourse, 85% when used 25 to 48 hours after intercourse,
and 58% when used 49 to 72 hours after intercourse. The corresponding figures for the Yuzpe method were 77%, 36%, and
31%.2 Although significant in several studies,2,8,11-13 this timeeffect relationship was not seen in other studies.7,9
A meta-analysis has demonstrated that the effectiveness of
post-coital IUDs approaches 100%, significantly higher than
the effectiveness of hormonal EC.14
7 days after unprotected intercourse. Appropriate indications
include the following situations:
• failure to use a contraceptive method
• condom breakage or leakage
• dislodgement of a diaphragm or cervical cap
• two or more missed birth control pills
• Depo-Provera injection over 1 week late
• ejaculation on the external genitalia
• mistimed fertility awareness
• sexual assault when the woman is not using reliable contraception
Because it is difficult to determine the infertile time of the
cycle with certainty,16-18 EC should be provided to a woman
who is concerned about her risk of pregnancy regardless of the
cycle day of exposure. Although ECPs are not recommended as
a regular form of contraception, repeat use poses no known
health risks and should not be a reason for denying women
access to treatment.
CONTRAINDICATIONS
The only absolute contraindication to the use of emergency hormonal contraception is known pregnancy. The effect of ECP
use in women already pregnant on the outcome of pregnancy
is unknown, but pregnancies in which the fetus has been
exposed to oral contraceptives (OCs) have shown no evidence
of teratogenicity.19
No substantial increased risk for developing venous thromboembolism has been found with combined hormonal EC.
However, studies of safety have frequently excluded women who
have contraindications to oral contraception.20 Since the levonorgestrel-only method carries no theoretical risk, it may be a
preferred option for women with significant contraindications
to estrogen – such as those with known thrombophilia, a history of stroke or heart attack, migraine headache with neurological symptoms, or smokers over age 35.21
If insertion of an IUD is considered, a preexisting pregnancy
must be excluded. This may require a sensitive urine pregnancy test or assay of serum human chorionic gonadotropin (hCG).
There should be no history of recent pelvic inflammatory disease, low risk for sexually transmitted infection, and no evidence
on examination of vaginal or cervical infection.
MECHANISM OF ACTION
Theoretically, EC could interfere with follicle maturation; the
ovulatory process; cervical mucus; sperm migration; corpus
luteum sufficiency; endometrial receptivity; fertilization; and
zygote development, transport, and adhesion.15 The mechanism of action may differ not only with the different EC methods, but also within each method, depending upon when it is
given relative to the time of both intercourse and ovulation.15
INDICATIONS
Hormonal emergency contraception should be considered for
any woman wishing to avoid pregnancy who presents within
5 days of unprotected or inadequately protected sexual intercourse. A post-coital IUD insertion can be considered up to
Table 1. Ovral and Substitutions
Brand
Pills per
Dose
Ethinyl
Estradiol
(µg/dose)
Levonorgestrel
(µg/dose)
Ovral
2
100
500
Alesse
5
100
500
Triphasil
4 yellow
120
500
Triquilar
4 yellow
120
500
4
120
600
MinOvral
SIDE EFFECTS
The common side effects of hormonal emergency contraception are gastrointestinal. The levonorgestrel method has a significantly lower incidence of nausea (23.1% versus 50.5%),
vomiting (5.6% versus 18.8%), dizziness, and fatigue than the
Yuzpe method.2 The antiemetic meclizine (available without
prescription) has been shown to reduce the risk of nausea when
taken orally in a dose of 50 mg 1 hour before the first dose of
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the condom can be used for the remainder of the current menstrual cycle, and a regular contraceptive method can be initiated at the beginning of the next cycle if the woman desires. A
woman who wishes to begin using OCs may be provided with
a prescription to start with her next period or the next day following the use of ECPs.29 She should use a condom until she
has taken the oral contraceptive pill for 7 consecutive days.
To maximize effective use of EC, women should have it
readily available when needed. Visits for periodic health examinations or reproductive health concerns give an opportunity
for health-care providers to offer a woman a prescription for EC
in advance of need.
the Yuzpe method, but its use increases the incidence of drowsiness.22 Less common side effects of both methods include
headache, bloating, abdominal cramps, and spotting or bleeding.23 Most women will have menstrual bleeding within 3 weeks
of taking ECPs.2
Possible complications of post-coital IUD insertion include
pelvic pain, abnormal bleeding, pelvic infection, perforation
and expulsion.23
MYTHS AND MISCONCEPTIONS
1. Emergency contraceptive pills cause a “mini-abortion.”
Fact: Emergency contraceptive pills have no effect on an
established pregnancy.19 They act prior to implantation and
therefore are not abortifacients.15
2. If emergency contraceptive pills are too easy to obtain,
women will “abuse” them.
Fact: Women who are supplied with emergency contraceptive pills in advance of need will use them appropriately and
are not more likely to abandon regular forms of birth
control.24-26
3. Emergency contraceptive pills have high doses of hormones
and are dangerous to use.
Fact: The brief one-time dose of hormone in emergency contraceptive pills is extremely safe and can be used by virtually
any woman who needs it.27
FOLLOW-UP
Women should be advised to have a pregnancy test if they do
not experience normal menstrual bleeding by 21 days after treatment (28 days if she began using OCs after taking ECPs). If
indicated, a follow-up appointment can be made to discuss contraception issues or to test for sexually transmitted infections.
TROUBLESHOOTING
Women who experience nausea or vomiting after taking hormonal EC should be advised to take an antiemetic such as
meclizine or dimenhydrinate. Using the levonorgestrel-only
method as a single-dose regimen (1.5 mg orally) obviates the
need for a second dose if nausea occurs, and may be preferred
for this reason.
If it is likely that a woman may forget to take her second
dose of the 2-dose regimen, the single-dose levonorgestrel regimen should be recommended. If the second dose is forgotten,
it can be taken up to 24 hours after the first without significant
change in pharmacokinetics compared to the 12-hour dosing
schedule.30
PROVIDING EMERGENCY CONTRACEPTION
In order to determine whether EC is indicated, it must be
determined that unprotected intercourse occurred within the
time frame when EC is effective. The woman’s risk for having
a preexisting pregnancy should be assessed by determining the
timing and character of her last menstrual period. Rarely, a
urine pregnancy test may be necessary to rule out pregnancy.
A history of previous unprotected intercourse during the
current cycle should not preclude the use of EC to lower risk
related to unprotected intercourse within the therapeutic window for EC.
Health-care providers should also discuss broader sexual
health concerns, such as whether the unprotected act was
coerced, risks for sexually transmitted infections, and need for
ongoing birth control. If nucleic acid amplification techniques
are available to test for chlamydia, urine testing for chlamydia
infection at the time of presentation for EC has been shown
to detect most cases. It should be considered for high-risk groups
(e.g., women under age 30) when reliable follow-up cannot be
guaranteed.28
Women should be informed about the potential side effects
of EC, and should be advised that hormonal EC will not prevent pregnancy resulting from unprotected intercourse in the
days or weeks following treatment. A barrier method such as
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DRUG INTERACTIONS
Although theoretically the serum concentrations of the ECP
hormones are affected by the use of drugs such as rifampicin
and certain anticonvulsants, the efficacy of ECPs in this situation is uncertain. A case report of a woman taking warfarin who
used the levonorgestrel-only ECP described a subsequent significant increase in anticoagulant effect.31
SUMMARY STATEMENTS
1. Women who have had unprotected intercourse and wish to
prevent pregnancy can be offered use of hormonal emergency
contraception up to 5 days after intercourse, (Level II-2) or
insertion of a copper IUD up to 7 days after intercourse, to
reduce the risk of pregnancy. (Level II-2)
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FEBRUARY 2004
randomized,controlled multicenter trial.Obstet Gynecol 2003;101:1160–7.
10. Rodrigues I, Grou F, Joly J. Effectiveness of emergency contraceptive pills
between 72 and 120 hours after unprotected intercourse.Am J Obstet
Gynecol 2001;184:531–7.
11. Ashok PW, Stalder C,Wagaarachchi PT, Flett GM, Melvin L,Templeton
A.A randomized study comparing a low dose of mifepristone and the
Yuzpe regimen for emergency contraception. BJOG 2002;109:553–60.
12. Xiao BL, von Hertzen H,Ahao H, Piaggio G.A randomized double-blind
comparison of two single doses of mifepristone for emergency contraception. Hum Reprod 2002;17:3084–9.
13. Piaggio G, von Hertzen H, Grimes DA,Van Look PFA.Timing of emergency contraception with levonorgestrel and the Yuzpe regimen. Lancet
1999;353:721.
14. Trussell J, Ellertson C. Efficacy of emergency contraception. Fertil Cont
Rev 1995;4:8–11.
15. Croxatto HB, Devoto L, Durand M, Ezcurra E, Larrea F, Nagle C, et al.
Mechanism of action of hormonal preparations used for emergency
contraception: a review of the literature. Contraception
2001;63:111–21.
16. Espinos JJ, Rodriguez-Espinosa J, Senosiain R,Aura M,Vanrell C, Gispert
M, et al.The role of matching menstrual data with hormonal measurements in evaluating effectiveness of postcoital contraception. Contraception 1999;60:215–20.
17. Wilcox A, Dunson D,Weinberg C,Trussell J, Baird D. Likelihood of conception with a single act of intercourse: providing benchmark rates for
assessment of post-coital contraceptives. Contraception 2001;63:211–15.
18. Stirling A, Glasier A. Estimating the efficacy of emergency contraception:
how reliable are the data? Contraception 2002;66:19–22.
19. Bracken MB. Oral contraception and congenital malformations in offspring: a review and meta-analysis of the prospective studies. Obstet
Gynecol 1990;76:552–7.
20. Vasilakis C, Jick SS, Jick H.The risk of venous thromboembolism in
users of postcoital contraceptive pills. Contraception 1999;59:79–83.
21. Webb A. How safe is the Yuzpe method of emergency contraception?
Fert Control Rev 1995;4:16-8.
22. Raymond EG, Creinin MD, Barnhart KT, Lovvorn AE,Wountree RW,
Trussell J. Meclizine for prevention of nausea associated with use of
emergency contraceptive pills: a randomized trial. Obstet Gynecol
2000;95:271–7.
23. Hatcher RA,Trussell J, Steward F, Cates W J, Stewart G, Guest F, et al. Contraceptive Technology. 17th ed. New York:Ardent Media Inc;1998, p. 851.
24. Glasier A, Baird D.The effects of self-administering emergency contraception. N Engl J Med 1998;339:1–4.
25. Ellertson C,Ambardekar S, Hedley A, Coyaji K,Trussell J, Blanchard K.
Emergency contraception: randomized comparison of advance provision and information only. Obstet Gynecol 2001;98:570–5.
26. Raine T, Harper C, Leon K, Darney P. Emergency contraception:
Advance provision in a young, high-risk clinic population. Obstet
Gynecol 2000;96:1–7.
27. Shelton JD. Repeat emergency contraception: facing our fears. Contraception 2002;66:19-22.
28. Kettle H, Cay S, Brown A, Glasier A. Screening for chlamydia trachomatis infection is indicated for women under 30 using emergency contraception. Contraception 2002;66:251–3.
29. Consortium for Emergency Contraception. Emergency contraceptive
pills: medical and service delivery guidelines.Available on-line at
<www.cecinfo.org/files/Medical-Service-Delivery-Gdelines.pdf>.Web
site updated March 2000.Accessed December 9, 2003.
30. Tremblay D, Gainer E, Ulmann A.The pharmacokinetics of 750 mcg
levonorgestrel following administration of one single dose or two
doses at 12- or 24-h interval. Contraception 2001;64:327–31.
31. Ellison J,Thomson AJ, Greer IA,Walker ID. Drug points: apparent
interaction between warfarin and levonorgestrel used for emergency
contraception. BMJ 2000; 321:1382.
2. The levonorgestrel emergency contraception regimen is more
effective and causes fewer side effects than the Yuzpe (ethinyl
estradiol–levonorgestrel) regimen. (Level I)
3. One double dose of levonorgestrel emergency contraception
(1.5 mg) is as effective as the regular 2-dose levonorgestrel
regimen (0.75 mg each dose), with no difference in side
effects. (Level I)
4. Advance provision of hormonal emergency contraception
increases the use of emergency contraception without decreasing the use of regular contraception. (Level II-2)
5. A pelvic examination is not a prerequisite to providing emergency contraception. (Level III)
RECOMMENDATIONS
1.Because the efficacy of hormonal emergency contraception may be higher if used sooner, it should be started as
soon as possible after an act of unprotected intercourse.
(Grade A)
2.Hormonal emergency contraception should be available
without a prescription in pharmacies, family planning
clinics, emergency rooms, walk-in clinics, and school
health programs. (Grade B)
3.Users of emergency contraception should be evaluated for
pregnancy if menses have not begun within 21 days following treatment. (Grade A)
4.Women and men of reproductive age should be counselled about emergency contraception. Women should be
offered a prescription in advance of need. (Grade B)
REFERENCES
1. US Department of Health and Human Services, Food and Drug Administration. Prescription drug products: certain combined oral contraceptives for use as postcoital emergency contraception. Federal Register
1997;62:8610–2.
2. Task Force on Postovulatory Methods of Fertility Regulation. Randomized controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet
1998;352:428–33.
3. Trussell J, Rodriguez G, Ellertson C. Updated estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception
1999;59:147–51.
4. Ho PC, Kwan MSW.A prospective randomized comparison of
levonorgestrel with the Yuzpe regimen in post-coital contraception.
Hum Reprod 1993;8:389–92.
5. Trussell J, Rodriguez G, Ellertson C. New estimates of the effectiveness
of the Yuzpe regimen of emergency contraception. Contraception
1998;57:363–9.
6. Trussell J, Ellertson C, Stewart F.The effectiveness of the Yuzpe regimen
of postcoital contraception. Fam Plann Perspect 1993;9:75-82.
7. von Hertzen H, Piaggio G, Din J, Chen J, Song S, Bartfai G, et al. Low
dose mifepristone and two regimens of levonorgestrel for emergency
contraception: a WHO multicentre randomised trial. Lancet
2002;360:1803–10.
8. Arowojolu AO, Okewole IA,Adekunle AO. Comparative evaluation of
the effectiveness and safety of two regimens of levonorgestrel for
emergency contraception in Nigerians. Contraception 2002;66:269–73.
9. Ellertson C,Webb A, Blanchard K, Bigrigg A, Haskell S, Shochet T, et al. Modifications of the Yuzpe regimen of emergency contraception: results of a
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Please note: The CPD Quiz including objectives and
questions will appear at the end of the third part.
156
FEBRUARY 2004
SOGC
CLINICAL
PRACTICE
GUIDELINES
No. 143 – Part 2 of 3, March 2004
CANADIAN CONTRACEPTION CONSENSUS
PRINCIPAL AUTHORS
CONTRIBUTING AUTHORS
Amanda Black, MD, FRCSC, Ottawa ON
Diane Francoeur, MD, FRCSC, Montréal QC
Timothy Rowe, MB, FRCSC,Vancouver BC
John Collins, MD, FRCSC, Mahone Bay NS
Dianne Miller, MD, FRCSC,Vancouver BC
PROJECT COORDINATOR
CONTRACEPTION GUIDELINES COMMITTEE
Elke Henneberg, Communications Message & More Inc., Montréal QC
Thomas Brown, PharmD,Toronto ON
Michèle David, MD, FRCPC, Montréal QC
Sheila Dunn, MD, CCFP(EM),Toronto ON
William A. Fisher, PhD, London ON
Nathalie Fleming, MD, FRCSC, Ottawa ON
Claude A. Fortin, MD, FRCSC, Montréal QC
Edith Guilbert, MD, MSc, Quebec City QC
Louise Hanvey, BN, MHA, Chelsea QC
André Lalonde, MD, FRCSC, Ottawa ON
Ruth Miller, MEd,Toronto ON
Margaret Morris, MD, FRSCS,Winnipeg MB
Teresa O’Grady, MD, FRCSC, St. John’s NL
Helen Pymar, MD, MPH, FRCSC,Toronto ON
Thirza Smith, MD, FRCSC, Saskatoon SK
Recommendations:
Chapter 4: Combined Hormonal Contraception
1. A range of hormonal contraceptives should be available to
ensure that the individual receives the preparation most suited for her needs. (Grade C)
2. Women using oral contraceptives should be counselled that
antibiotic use does not appear to affect combined OC efficacy (except for griseofulvin and rifampicin). (Grade B)
Chapter 5: Progestin-Only Hormonal Contraception
1. Progestin-only methods should be considered as contraceptive
options for postpartum women, regardless of breastfeeding
status, and may be introduced immediately after delivery.
(Grade B)
2. Progestin-only methods should be considered as contraceptive
options for women with a past history of venous thromboembolism (VTE), or for women who are at a higher risk of
myocardial infarction or stroke. In women with a proven
thrombophilia, progestin-only preparations should be used
with caution. (Grade B)
3. Young women who use depot medroxyprogesterone acetate
(DMPA) should be counselled about dietary and lifestyle factors that will affect their peak bone mass, such as smoking,
exercise, and calcium intake. (Grade A)
Chapter 6: Special Considerations for Hormonal
Contraception
1. All women who smoke should be counselled to stop. Women
over 35 who smoke should be advised not to use combined
oral contraceptives (OCs). (Grade A)
Abstract
Objective: To provide guidelines for health-care providers on
the use of contraceptive methods to prevent pregnancy and
sexually transmitted diseases.
Outcomes: Overall efficacy of cited contraceptive methods,
assessing reduction in pregnancy rate, risk of infection, safety,
ease of use, and side effects; the effect of cited contraceptive
methods on sexual health and general well-being; and the cost
and availability of cited contraceptive methods in Canada.
Evidence: Medline and the Cochrane Database were searched
for articles in English on subjects related to contraception, sexuality, and sexual health from January 1988 to March 2003, in
order to update the Report of the Consensus Committee on
Contraception published in May-July 1998. Relevant Canadian
Government publications and position papers from appropriate
health and family planning organizations were also reviewed.
Values: The quality of the evidence is rated using the criteria
described in the Report of the Canadian Task Force on the
Periodic Health Examination. Recommendations for practice
are ranked according to the method described in this Report.
Key Words
Contraception, statistics, Canada, sexuality, sexual health, hormonal
contraception, emergency contraception, barrier methods of contraception, contraceptive sponge, female condoms, contraceptive
diaphragm, cervical cap, spermicide, fertility awareness, abstinence,
tubal ligation, vasectomy, sterilization, intrauterine devices
These guidelines reflect emerging clinical and scientific advances as of the date issued and are subject to change.The information should not be construed as
dictating an exclusive course of treatment or procedure to be followed. Local institutions can dictate amendments to these opinions. They should be well
documented if modified at the local level. None of the contents may be reproduced in any form without prior written permission of SOGC.
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2. Women using combined OCs who are undergoing major
surgery or surgery that will be followed by prolonged periods
of immobility should receive peri-operative anti-thrombotic
prophylaxis. (Grade A) Consideration may be given to discontinuing low-dose combined OCs 4 weeks prior to elective
surgery. A reliable contraceptive method (e.g., progestin-only
contraception) should be substituted when combined OCs
are withdrawn. (Grade C)
Chapter 7: Intrauterine Devices
1. Health-care professionals providing family planning services
should be familiar with the use of the intrauterine device
(IUD). (Grade A)
2. Appropriately trained personnel in adequately equipped facilities should be available in order to ensure that women have
access to the IUD if they desire this method of contraception.
(Grade A)
the amount of progestin increases in the second half of the
cycle); or triphasic (the amount of estrogen may be fixed or variable, while the amount of progestin increases in 3 equal phases). Biphasic and triphasic formulations were initially developed
with the intent of lowering the total steroid content of combined OCs.3
Two types of estrogen are used in combined OCs: ethinyl
estradiol and mestranol. Mestranol is a “prodrug” that is
converted in vivo to ethinyl estradiol.4 Several different progestins, of varying degrees of progestational potency, are used in
combined OCs. The progestins may also have estrogenic, antiestrogenic, or androgenic activity. The “potencies” attributed to
different combined OC preparations are based on pharmacological experimental models. These include the mouse uterine
weight assay for estrogenic activity, demonstration of glycogen
vacuoles in human endometrium for progestogenic activity, and
the rat ventral prostate assay for androgenic activity.5,6 However, there is no clear clinical or epidemiological evidence that
compares the relative potencies of currently available combined
OCs. The many variables that affect the potency of combined
OCs (including dosage, bioavailability, protein binding, receptor binding affinity, and interindividual variability) make it difficult to extrapolate the results of isolated experiments to provide
clinically relevant information in humans.4
Progestins can be classified according to their chemical
structure as an estrane (norethindrone, ethynodiol diacetate) or
as a gonane (levonorgestrel, desogestrel, norgestimate). In general, the gonane progestins appear to be more potent than the
estrane derivatives (smaller doses can be used), but otherwise
differences between the estrane and gonane compounds are difficult to characterize.7,8 Progestins have also been classified
according to the sequence of their development (first, second,
or third generation), but the definitions of first, second, or third
generation progestins are not universally accepted. Newer progestins (norgestimate and desogestrel) have been shown to have
little or no androgenic activity.7,8 These progestins, when
administered in combination with ethinyl estradiol, produce a
net estrogen-dominant effect, which may partly explain the
effects seen on hepatic proteins (increased levels of sex hormonebinding globulin), lipid metabolism (increased levels of triglycerides and high-density lipoprotein-cholesterol), and on
haemostatic variables (increased levels of fibrinogen, plasminogen, and Factor VII).7,8
J Obstet Gynaecol Can 2004;26(3):219–54.
CHAPTER 4: COMBINED HORMONAL CONTRACEPTION
Amanda Black, MD, FRCSC,1 Nathalie Fleming, MD,
FRCSC,2 Helen Pymar, MD, MPH, FRCSC,3 Thomas
Brown, PharmD,4 Thirza Smith, MD, FRCSC5
1Ottawa
ON
ON
3Toronto ON
4Toronto ON
5Saskatoon SK
2Ottawa
Combined hormonal contraception refers to contraceptive
methods that contain both estrogen and a progestin. There
are several forms of combined hormonal contraceptive methods, including the combined oral contraceptive pill, the transdermal contraceptive patch, the vaginal contraceptive ring, and
the combined monthly injectable. At this time, only the combined oral contraceptive pill and the contraceptive patch are
approved for use in Canada. Newer combined oral contraceptive pills and the vaginal contraceptive ring will hopefully be
available in Canada in the future.
COMBINATION ORAL CONTRACEPTIVE PILL
INTRODUCTION
The oral contraceptive pill (combined OC) was first introduced
in 1960. Since then it has undergone many modifications and
has been used by millions of women worldwide. In Canada,
18% of women aged 15 to 49 use the combined OC.1 Of
Canadian women who use contraception, 32% use the combined OC as their method of birth control.2
The combined OC preparations available in Canada are
shown in Table 1. Formulations may be monophasic (each
tablet contains a fixed amount of estrogen and progestin);
biphasic (each tablet contains a fixed amount of estrogen, while
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EFFICACY
The combined OC is a highly effective method of reversible
contraception. With perfect use, the combined OC is 99.9%
effective in preventing pregnancy.9 However, typical user failure rates range from 3 to 8%.10,11
Poor patient compliance is a major factor in limiting effectiveness. In one study, the proportion of women who reported
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MARCH 2004
Table 1. Composition of Various Combination Hormonal
Contraceptives
Type
Preparations
Estrogen
(mg)
Progestin
(mg)
Ethinyl estradiol /
desogestrel
Marvelon
Ortho-Cept
0.030
0.030
0.15
0.15
Ethinyl estradiol /
ethynodiol
diacetate
Demulen 30
0.030
2
Ethinyl estradiol /
levonorgestrel
Min-Ovral
Alesse
0.030
0.020
0.15
0.10
Ethinyl estradiol /
norelgestromin
Evra (patch)
0.020
0.15
Ethinyl estradiol /
norethindrone
Brevicon
0.5/35
Ortho 0.5/35
Brevicon 1/35
Ortho 1/35
Select 1/35
0.035
0.5
0.035
0.035
0.035
0.035
0.5
1
1
1
Ethinyl estradiol /
norethindrone
acetate
MinEstrin 1/20
LoEstrin 1.5/30
0.020
0.030
1
1.5
Ethinyl estradiol /
norgestimate
Cyclen
0.035
0.25
Ethinyl estradiol /
norgestrel
Ovral
Lo-Femenol
0.050
0.030
0.5
0.3
Ortho-Novum
1/50
Norinyl
0.050
1
0.050
1
Diane 35*
0.035
2
Synphasic
0.035
(12 tabs)
0.035
(9 tabs)
0.5
0.035
(7 tabs)
0.035
(7 tabs)
0.035
(7 tabs)
0.5
missing no pills (53 to 59%) was much higher than the proportion recorded electronically (19 to 33%). According to the
electronic devices, 30% of women missed 3 or more pills in the
first cycle of combined OC use.12 Another study found that
47% of women miss 1 or more pills and 22% miss 2 or more
pills per cycle.13
The effect of body weight on the efficacy of the combined
OC is controversial. A retrospective cohort study found that
women weighing 70.5 kg or more had a significantly increased
risk of combined OC failure compared with women of lower
body weight. The relative risk of failure was 2.6 among lowdose combined OC users and 4.5 among very-low-dose combined OC users.14 However, a large cohort study failed to find
evidence of any influence of body weight on the risk of accidental pregnancy in combined OC users.15 Further studies are
required before recommendations can be made.
Combination
Monophasic
Mestranol /
norethindrone
Ethinyl estradiol /
cyproterone acetate
MECHANISM OF ACTION
The combined OC’s multiple mechanisms of action may contribute to its high efficacy. Its main mechanism of action is to
suppress gonadotropin secretion, thereby inhibiting ovulation.16
Other mechanisms of action include:
• Development of endometrial atrophy, making the
endometrium unreceptive to implantation;17
• Production of viscous cervical mucus that impedes sperm
transport;18
• Possible effect on secretion and peristalsis within the fallopian tube, which interferes with ovum and sperm transport.16
Biphasic
Ethinyl estradiol /
norethindrone
1
INDICATIONS
Triphasic
Ethinyl estradiol /
norethindrone
Ethinyl estradiol /
norgestimate
Ethinyl estradiol /
levonorgestrel
Ortho 7/7/7
Tri-Cyclen
Triquilar
Triphasil
0.035
(7 tabs)
0.035
(7 tabs)
0.035
(7 tabs)
0.030
(6 tabs)
0.040
(5 tabs)
0.030
(10 tabs)
0.030
(6 tabs)
0.040
(5 tabs)
0.030
(10 tabs)
In the absence of contraindications, use of the combined OC
may be considered for any woman seeking a reliable, reversible,
coitally-independent method of contraception. It is particularly
suited for women who wish to take advantage of its noncontraceptive benefits.
The use of condoms is still recommended in combined OC
users for protection against sexually transmitted infections
(STIs) and human immunodeficiency virus (HIV).
0.75
1
0.18
0.215
0.25
CONTRAINDICATIONS
0.05
The World Health Organization (WHO) has developed a list
of absolute and relative contraindications to the use of combined OCs, based on the available evidence of risks.9
0.075
0.125
0.05
ABSOLUTE CONTRAINDICATIONS
0.075
• < 6 weeks postpartum if breastfeeding
• smoker over the age of 35 (≥ 15 cigarettes per day)
• hypertension (systolic ≥ 160mm Hg or diastolic
≥ 100mm Hg)
0.125
*indicated for severe acne, should not be prescribed solely for its contraceptive
properties
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can help to prevent unnecessary discontinuation and enhance
compliance.60-61 The most common reason patients discontinue combined OC use is abnormal menstrual bleeding, followed
by nausea, weight gain, mood changes, breast tenderness, and
headache.60
• current or past history of venous thromboembolism
(VTE)
• ischemic heart disease
• history of cerebrovascular accident
• complicated valvular heart disease (pulmonary hypertension, atrial fibrillation, history of subacute bacterial
endocarditis)
• migraine headache with focal neurological symptoms
• breast cancer (current)
• diabetes with retinopathy/nephropathy/neuropathy
• severe cirrhosis
• liver tumour (adenoma or hepatoma)
1. IRREGULAR BLEEDING
Unexpected bleeding occurs in 10 to 30% of women in the
first month of combined OC use62-64, and is a common reason for discontinuing use of combined OCs.60,62,65-67 The actual incidence of breakthrough bleeding or spotting is difficult
to know as it is defined in various ways in different studies. It
does appear that breakthrough bleeding or spotting in women
beginning combined OC use improves with time.68-70 The
likelihood of irregular bleeding is greater during the first 3
cycles of combined OC use, although rates at 3 months do not
differ significantly from rates at 1 month.69-70 Randomized trials have compared the rates of irregular bleeding between 2
or 3 products, but no single comprehensive study has compared the rates of irregular bleeding in all of the existing combined OC formulations. Amenorrhea occurs in approximately
2 to 3% of cycles.62
RELATIVE CONTRAINDICATIONS
• smoker over the age of 35 (< 15 cigarettes per day)
• adequately controlled hypertension
• hypertension (systolic 140–159mm Hg, diastolic
90–99mm Hg)
• migraine headache over the age of 35
• currently symptomatic gallbladder disease
• mild cirrhosis
• history of combined OC-related cholestasis
• users of medications that may interfere with combined
OC metabolism
2. BREAST TENDERNESS AND NAUSEA
Breast tenderness and nausea may occur, but generally improve
with time.71 These symptoms may occur less often in women
who use combined OCs containing smaller amounts of
estrogen.59
NON-CONTRACEPTIVE BENEFITS
In addition to providing effective contraception, the combined
OC has a number of non-contraceptive benefits that may make
it an attractive option for many women. These include
• cycle regulation
• decreased menstrual flow19,20
• increased bone mineral density21-24
• decreased dysmenorrhea19,25-27
• decreased peri-menopausal symptoms28,29
• decreased acne30-36
• decreased hirsutism37
• decreased endometrial cancer38-42
• decreased ovarian cancer43-48
• decreased risk of fibroids49,50
• possibly fewer ovarian cysts51
• possibly fewer cases of benign breast disease52
• possibly less colorectal carcinoma53-55
• decreased incidence of salpingitis56,57
• decreased incidence or severity of moliminal symptoms58
3. WEIGHT GAIN
Although weight gain is often thought to be a side-effect of the
combined OC,72 placebo-controlled trials have failed to show
any association between low-dose combined OCs and weight
gain.73-76 Studies comparing the combined OC to other contraceptive methods have also failed to show a significant OCassociated weight gain.
4. MOOD CHANGES
Although women may report depression and mood changes
while taking the combined OC, placebo-controlled trials have
not demonstrated a significantly increased risk of mood changes
in combined OC users compared to placebo users.73
RISKS
1. VENOUS THROMBOEMBOLISM
The rates of venous thromboembolism in combined OC users
are 3- to 4-fold higher than among non-users.77 The absolute
risk of VTE in combined OC users is 1 to 1.5 per 10 000 users
per year of use. The risk of VTE during the first year of use
appears to be higher than that in subsequent years of use.78-79
(See chapter 6: Special Considerations for more information.)
SIDE-EFFECTS
Some combined OC users will experience minor side-effects,
most commonly during the first 3 cycles.59 These side-effects
may lead to discontinuation of the combined OC. Reassurance
and adequate counselling about expected common side-effects
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the use of the combined OC and breast cancer.102 Among current combined OC users, the relative risk was 1.0 (95% CI
0.8–1.3), and among former users the relative risk was 0.9 (95%
CI 0.8–1.0). The risk did not increase with longer periods of
use, with different dosages of estrogen, or with different progestin components. The risk of breast cancer was not increased
in women with a family history of breast cancer who used the
combined OC, or in women who started using the combined
OC at an earlier age.
It is possible that women who carry the BRCA1 gene or
BRCA2 gene mutations may be at a higher risk of breast cancer than other women when using combined OCs.103-105
2. MYOCARDIAL INFARCTION
In women taking a combined OC containing more than 50 µg
of ethinyl estradiol, myocardial infarction rates increase
3-fold.80-81 However, a number of recent studies have found no
significant increase in the risk of myocardial infarction with
preparations containing less than 50 µg of ethinyl estradiol, irrespective of age.82-85 (See chapter 6: Special Considerations for
more information.)
3. STROKE
A significantly increased risk of stroke is seen in users of combined OCs that contain more than 50 µg of ethinyl estradiol.86
Although some studies of low-dose combined OCs report no
increase in the risk of stroke,87-88 others have reported an
increased risk of up to 2-fold.89-92 Smoking and hypertension
are major risk factors for stroke.93 Combined OC users with
hypertension are at an increased risk of stroke relative to users
without hypertension.94 A meta-analysis published in 2000
reported an odds ratio of 1.93 (95% confidence interval [CI],
1.35–2.74) for current combined OC preparations in studies
that controlled for smoking and hypertension.95 (See chapter 6:
Special Considerations for more information.)
6. CERVICAL CANCER
Although human papillomavirus (HPV) is known to be linked
to cervical cancer, many studies did not take this into account
when studying combined OC use and the risk of cervical neoplasia. One study suggests that long-term combined OC use
may increase the risk of cervical cancer in women who are HPV
positive but not in women who are HPV negative.106 A systematic review of 28 studies of women with cervical cancer also
found that increasing the duration of combined OC use was
associated with an increased risk of cervical cancer.107 The data,
although limited, suggested that the relative risk of cervical cancer may decrease after use of combined OCs ceases. Infection
with HPV, the major risk factor for cervical cancer,108 is related to sexual behaviour, and sexual behaviour may differ between
combined OC users and non-users. A long-term study published in 2002 concluded that, in a well-screened population of
HPV-positive women followed for 10 years, combined OC use
did not increase the risk of cervical cancer.109 The specific role
that combined OCs play in the development of cervical cancer
remains uncertain.
4. GALLBLADDER DISEASE
Combined OC use increases the secretion of cholic acid in bile,
potentially leading to a higher incidence of gallstone formation.96 However, there does not appear to be a significantly
increased risk of gallstone formation in combined OC users.97-98
5. BREAST CANCER
Despite numerous studies, the risk of breast cancer in combined
OC users is still controversial. A case-control study published
in 1986 showed no association between the use of the combined
OC and the risk of breast cancer.99 The best data available until
recently were the results of a large meta-analysis published in
1996.100 The results of this study suggested that there was a
small but significant increase in risk of breast cancer in women
who were currently taking the combined OC (relative risk [RR],
1.24; 95% CI, 1.15–1.33) and in the first 10 years after discontinuing it. There did not appear to be a significant excess
risk of having breast cancer diagnosed 10 or more years after
stopping the combined OC.100 To put this into perspective, the
cumulative likelihood of breast cancer up to the age of 35 in
Canadian women is approximately 2 per 1000 women.101 If
these 1000 women were using combined OCs, and if the associated breast cancer risk was 1.5-fold higher, they would experience 3 cases of breast cancer by the age of 35 rather than
2 cases. It is unclear whether the small increase in breast cancer
risk associated with combined OC use is related to the OC itself
or to delaying the first full-term birth.
In a more recent study of over 9000 women between the
ages of 35 and 64, there was no significant association between
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MYTHS AND MISCONCEPTIONS
Numerous myths and misconceptions exist concerning the
combined OC.
1. The combined OC causes cancer.
Fact: The combined OC reduces the risks of ovarian and
endometrial cancer. The risk of ovarian cancer is reduced by
at least half in women who use combined OCs.43-48,110 A
meta-analysis of 20 studies of combined OC use indicated
that the risk of ovarian cancer decreased with increasing duration of OC use, reducing by 10 to 12% after 1 year of use
and by approximately 50% after 5 years of use.45 This reduction in risk persists for 10 to 20 years after combined OC use
has been discontinued. The reduced risk of ovarian cancer
in combined OC users has also been noted in women who
have a pathogenic mutation in the BRCA1 or BRCA2 gene,
a mutation that increases their lifetime risk of developing
ovarian cancer.48,111 The combined OC is associated with a
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2.
3.
4.
5.
6.
50% overall reduction in the risk of endometrial cancer40
and the protective effect persists long after the combined OC
is discontinued.42 The combined OC may also have a protective effect against colorectal cancer.53-55 There appears to
be either no increase99,102 or a very slight increase100 in the
risk of breast cancer in current combined OC users.
Women on the combined OC should have periodic pill
breaks.
Fact: This is unnecessary. Pill breaks place a woman at risk
for unintended pregnancy and cycle irregularity.67,112
The combined OC affects future fertility.
Fact: Fertility is restored within 1 to 3 months after stopping
the combined OC.67,113
The combined OC causes birth defects if a woman becomes
pregnant while taking it.
Fact: There is no evidence that the combined OC causes
birth defects if it is taken inadvertently during pregnancy.114
The combined OC must be stopped in all women over 35
years old.
Fact: Healthy, non-smoking women may continue to use the
combined OC until menopause.113
The combined OC causes acne.
Fact: Acne improves in women using the combined OC30-36
due to a decrease in circulating free androgen.115 Although all
combined OCs will result in an improvement of acne, 2 combined OCs in Canada have received official labelling for the
treatment of acne; these 2 OCs contain ethinyl estradiol in
combination with either levonorgestrel or norgestimate. The
combination pill with cyproterone acetate is indicated for the
treatment of severe acne and is also a contraceptive.
should include the following:
• instructions on how to take the combined OC
• information on potential side-effects
• non-contraceptive benefits of the combined OC
• addressing common myths and misconceptions
• discussing risks and warning signs, including when to
seek medical care
• discussing what to do if pills are missed
• emphasizing dual protection (the combined OC with
condom use to prevent STIs and HIV infection)
• information about emergency contraception in the event
of missed pills
3. PRESCRIPTION
• The choice of a combined OC, for first-time users, should
take into account the prescriber’s clinical judgment and
the preferences of the user. A low-dose preparation
(≤ 35 µg of ethinyl estradiol) is preferred. The preparation of choice for the combined OC user is the one that
provides effective contraception, acceptable cycle control,
and the least side-effects for that individual.
• Various start dates for the combined OC are used. Conventionally, the combined OC is started during the first
5 days of the menstrual cycle or on the first Sunday after
menses begin. If the combined OC is started within the
first 5 days of the menstrual cycle, a backup method of
contraception is not necessary for prevention of pregnancy, provided that no pills have been missed. Another
alternative is the Quick Start method, where a combined
OC user takes her first pill in the health-care provider’s
office after ruling out pregnancy.116-118 A back-up method
of contraception should be used for the first week after
combined OC initiation if the Quick Start method is
used.118 This method, with its simple starting instructions, improves compliance, particularly in adolescents,116-118 and is not associated with an increase in the
incidence of breakthrough bleeding or other sideeffects.115,117
• Women who use a 21-day preparation should be cautioned
never to exceed the 7 day pill-free interval between packs.
• The health-care provider may discuss emergency contraception (EC) as well as providing an EC prescription
in advance of need.
• Dual protection with condoms should be re-emphasized.
• A follow-up visit should be scheduled to review the combined OC users’ experience, satisfaction, and compliance,
as well as to perform a blood pressure check. If indicated,
a pelvic examination can be performed at the follow-up
visit.
Combined OC prescribers should take steps to reduce longterm costs, and improve follow-up and oral contraceptive tracking, by eliminating indiscriminate “free sampling.” Initiation
INITIATION
1. PATIENT ASSESSMENT
Before prescribing a combined OC, a thorough history should
be taken, including potential contraindications, smoking history, and medications. The physical examination should include
a blood pressure measurement. A pelvic examination, although
an important aspect of well-woman care, is not mandatory
before providing combined OCs. The pelvic examination may
be postponed until a follow-up visit. Negotiating the pelvic
examination may be particularly important with adolescents.
No routine laboratory screening is required. Assessing the
cholesterol-lipoprotein profile and carbohydrate metabolism
should follow the Guidelines from the Canadian Periodic
Health Examination. Routine screening for thrombophilias is
not recommended.
2. COUNSELLING
Adequate counselling prior to initiation of combined OCs may
help to improve compliance (regular use) and adherence (continuation).60-61,66 Counselling with regard to combined OC use
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84 days, with most women choosing a hormone-free interval of
4 to 5 days. Breakthrough bleeding and spotting was a common reason for returning to a 21-day combined OC regimen. It
is therefore essential to counsel that breakthrough bleeding will
decrease over time.128 The use of a monophasic pill regimen129
or a 21-day OC regimen prior to extending the cycle128 has been
shown to decrease the incidence of breakthrough bleeding when
using the extended combined OC regimens. To reduce the incidence of breakthrough bleeding and improve patient satisfaction,
women should have minimal side-effects during their 21 hormone days before extending their regimen.
of therapy with a single sample pack, for immediate protection
and for demonstration purposes, should be accompanied by a
prescription. For patients who are unable to pay for their medications and are not covered by a private insurance plan or government assistance, health-care providers can apply to the
National Compassionate Oral Contraceptive Program on their
behalf. This program ensures that access to contraception is not
denied on the basis of lack of funds. (Go to http://sogc.medical
.org/forms/pdfs/factSheetCompassion_e.pdf for more
information about the program. Go to http://www.sogc.org
/forms/pdfs/compassionform%5Fe.pdf to access the application form.)
VAGINAL ADMINISTRATION OF COMBINED
ORAL CONTRACEPTIVES
CONTINUOUS USE OF COMBINED
ORAL CONTRACEPTIVE PILLS
Six clinical trials have evaluated the administration of combined
OCs given vaginally.130-136 Theoretical advantages in administering the combined OC vaginally include avoiding the “first
pass” metabolism by the liver, which may help to decrease sideeffects and improve tolerance. The largest study of this method
of administration involved 1055 women and resulted in pregnancy rates of 2.78% at one year with use of a preparation containing 50 µg ethinyl estradiol with 250 µg levonorgestrel
(1 Ovral tablet daily), and 4.54% at one year with use of a
preparation containing 30 µg ethinyl estradiol with 150 µg desogestrel (1 Orthocept or 1 Marvelon tablet daily). No significant difference in pregnancy rates was reported between these
two products when administered vaginally.132 Failure rates in
this study were not compared to those seen with oral administration of combined OCs.
The use of combined oral contraceptive pill on a continuous
basis was first studied in 1977, using 50 µg ethinyl estradiol
pills.119 When given in a continuous fashion, the combined
OC may have a number of advantages including decreased
incidence of pelvic pain, headaches, bloating/swelling, and
breast tenderness for women who experience these symptoms
during the pill-free interval120; improved control over symptoms of endometriosis121 and polycystic ovary syndrome122;
and greater convenience due to fewer withdrawal bleeds per
year. Disadvantages of giving the combined OC in a continuous fashion include little information on long-term safety
(although there are long-term data for comparable total estrogen-progestin doses per month123) and a slightly higher cost
for medications (an extra 3 pill packages per year for a 91-day
cycle). These potential disadvantages must be weighed against
the likely reduction in the cost of sanitary supplies, in pain
medication, and in time off work or school; more breakthrough bleeding initially124-125; and possible delay in the
recognition of pregnancy.
In 2 surveys of women, many respondents preferred amenorrhea or less painful and shorter periods to having menstrual
bleeding every 4 weeks. In Australia, 46% of (158) female
patients and 55% of (20) young female doctors surveyed would
choose to bleed at intervals of 3 months or greater if they could
choose their own pill regimen.126 In the Netherlands, adolescent
females preferred less painful and shorter menstrual bleeding,
and women age 45 to 49 preferred amenorrhea to having menstrual bleeding every 4 weeks.127
A retrospective study of 267 women who initiated a continuous OC regimen found that 64% of the women continued with
this regimen; 86% reported an improvement in their original
problem such as headache and dysmenorrhea and 76% reported
a high degree of satisfaction.120 The women were counselled to
take the combined OC until they experienced breakthrough
bleeding, or completed 2 pill packages (42 days), 3 pill packages
(63 days), or 4 pill packages (84 days). The mean cycle length was
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TROUBLESHOOTING
1. BREAKTHROUGH BLEEDING
The rates of irregular bleeding reported by women in clinical
trials of combined OCs vary widely.59,68,137-138 Bleeding rates
at 3 months do not appear to differ significantly from those at
1 month69; therefore, new users of a combined OC should be
encouraged to continue with the expectation that any irregular bleeding will subside, rather than switching to another combined OC. An improvement in bleeding patterns is usually
seen over time, so that reassurance and a reminder of the usually transient nature of irregular bleeding is essential. A Pap
smear, STI testing, or a pregnancy test may be performed if
indicated.
If the bleeding persists after the third cycle of use, or has a
new onset, other causes of bleeding must be ruled out. Possible
reasons for irregular bleeding while taking the combined OC
include irregular pill taking139, smoking140, uterine or cervical
pathology, malabsorption, pregnancy, use of concomitant
medications (e.g. anticonvulsants, rifampin, herbal medicines),
and infection.141 Health-care providers should rule out these
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potential causes of irregular bleeding. The patient should be
asked about the duration of pill use, dosage, timing, missed pills,
symptoms of pregnancy, diarrhea or vomiting in the last cycle,
dyspareunia, vaginal bleeding after intercourse, smoking, and
the use of other medication.113 New onset of irregular bleeding
in a long-term combined OC user may be a marker for chlamydia infection (up to 29% of these women may have a positive
chlamydia test141), so that these women should be screened for
Chlamydia infection.62
Several empirical regimens have been used to manage breakthrough bleeding once other causes have been eliminated,
although there is no reliable evidence to support them.62 In the
case of persistent or new onset bleeding, a short course of oral
estrogen may be helpful, such as 1.25 mg of conjugated estrogen or 2 mg of estradiol-17β daily for 7 days. If no improvement is seen, a therapeutic trial of another combined OC may
be indicated. It may be useful to offer a combined OC containing a different type of progestin, such as switching from a
preparation that contains a gonane progestin to one that contains an estrane progestin (or vice versa). There is no combined
OC preparation that is less likely than others to cause breakthrough bleeding. Consistent pill use, dual protection, and
smoking cessation should be emphasized.
preparation may be effective. There is usually no indication to
switch to a pill containing 50 µg ethinyl estradiol.
4. CHLOASMA
Chloasma, a darkening of facial skin pigmentation, may occur
during OC use. If chloasma occurs, changing to another pill
will not help.113 The hyperpigmentation may never completely disappear. The use of sunscreen may help to prevent further
pigmentation.
5. BREAST TENDERNESS (MASTALGIA) AND
GALACTORRHEA
Mastalgia often resolves after several cycles of combined OC
use.113 Decreasing caffeine intake may be helpful in reducing
mastalgia. Decreasing the estrogen content of the combined
OC may also be helpful.113 The presence of galactorrhea during combined OC use is rare and is an indication for performing a serum prolactin assay.
6. NAUSEA
Nausea is a common side effect during the first cycles of combined OC use, and usually decreases with time.71 However, nausea or vomiting may occur when a woman takes 2 pills at the
same time. Taking the pills a few hours apart may be helpful in
this case. Taking the pill with food or at bedtime will often control the nausea. A lower estrogen dose may improve the nausea.113,142 If nausea occurs in a long-time pill user, pregnancy
must be ruled out.
2. MISSED PILLS
Missing pills at the beginning or end of the 21-day cycle has the
effect of lengthening the hormone-free interval. If the hormonefree interval exceeds 7 days, the risk of ovulation and possible
conception is increased. Forgetting tablets in the second or third
week of the 21-day cycle is unlikely to increase the risk of ovulation if the hormone-free interval does not exceed 7 days.
7. PREGNANCY
If pregnancy occurs in a woman taking a combined OC, she
should stop taking the pill immediately. She should be informed
that there is no increased risk of birth defects as a result of inadvertent combined OC use during pregnancy.143
3. AMENORRHEA
Amenorrhea occurs in 2 to 3% of combined OC users.62 Pregnancy should first be ruled out in any OC user who develops
amenorrhea. Amenorrhea in women taking combined OCs is
not dangerous, and many women readily accept the absence of
withdrawal bleeding. If amenorrhea is unacceptable, adding
exogenous estrogen (e.g., 0.625–1.25 mg conjugated estrogens
or 1–2 mg of 17β estradiol) for 10 days per cycle will often
result in resumption of bleeding.113 Switching to another
DRUG INTERACTIONS
Ethinyl estradiol is metabolized at several different sites. First, it
is sulphated in the intestinal wall, then it is hydroxylated in the
cytochrome P450-3∆4 pathway of the liver, after which it is conjugated with glucuronides and passes into the enterohepatic
Instructions Regarding Missed Pills
If you miss 1 pill, take it as soon as you remember. This may mean taking 2 pills in 1 day.
If you miss 2 pills in a row during the first 2 weeks of the pack, take 2 pills on the day you remember and 2 on
the following day. Use a backup method of contraception if you have sex in the 7 days after you miss the pills.
If you have had unprotected intercourse after missing a pill, use emergency contraception.
If you miss 2 pills in a row in the third week of the pack, throw out the remainder of the pack and start a new
pack on the day you remember. You may not have a period this month. If you had unprotected intercourse after
missing a pill, use emergency contraception.
If you miss 3 pills in a row, throw out the remainder of the pack and start a new pack on the day you remember.
If you had unprotected intercourse after missing a pill, use emergency contraception. Use a backup method of
contraception if you have intercourse in the first 7 days of the new pack. You may not have a period this month.
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circulation.144 These processes may vary between women and may
be affected by other medications. Drug interactions may occur
via alterations in absorption, serum protein binding, receptor
binding or in hepatic metabolism.145,146 The clinical significance
of many of the interactions is questionable. It has been suggested that less than 5% of drug interactions with combined OCs
result in pregnancy.146 Nevertheless, due to the widespread use of
combined OCs, health-care professionals must be aware of concurrent medication use and the potential for drug interactions.
Evidence from a single pharmacokinetic interaction study
suggests that a woman taking the anticonvulsant phenytoin or
carbamazepine should use a combined OC preparation containing 50 µg ethinyl estradiol, rather than a lower-dose preparation.147 Monitoring of phenytoin concentrations is important
because combined OCs may inhibit their metabolism.146
Whether or not antibiotic use has an effect on the efficacy
of combined OCs has been a matter of controversy. A significant pharmacokinetic interaction between combined OCs and
antibiotics, apart from rifampicin and griseofulvin,148 has not
been proven. It has been suggested that if an interaction does
exist, it is likely that it occurs in a small number of predisposed
individuals.148 It is not possible at this time to predict who is at
risk for potential interaction.
Table 2 shows significant drug interactions with combined
OCs. Some medications may result in contraceptive failure if
used concomitantly with combined OCs. Some medications
may increase the activity of the combined OC, 146,149,150 resulting in increased estrogenic side-effects. Oral contraceptives may
also decrease the clearance of other medications, thereby increasing their activity.146,149,150 Other drug interactions may occur
but are not included in the table because of a lack of scientific
documentation or questionable clinical significance.
contraceptive patch delivers 150 µg of norelgestromin (the primary active metabolite of norgestimate) and 20 µg of ethinyl
estradiol daily to the systemic circulation.151 These doses cannot be compared to the doses of estrogen and progestin in a
combined oral contraceptive. One patch is applied weekly for
3 consecutive weeks, followed by 1 patch-free week. The patch
is placed on 1 of 4 sites: the buttocks, upper outer arm, lower
abdomen or upper torso, excluding the breast.
EFFICACY
Overall, studies have found that the Pearl Index with perfect
use of the contraceptive patch is 0.7 (95% CI, 0.31–1.10), while
with typical use the Pearl Index is 0.88 (95% CI,
0.44–1.33).138,152,153 A subgroup of women weighing more
than 90 kg may have an increased risk of pregnancy while using
the patch.152,153 In one study, 4 of the 6 pregnancies that
occurred were in women weighing at least 90 kg152; in a pooled
analysis, 5 of the 15 pregnancies that occurred in patch users
were in women weighing more than 90 kg.153 The contraceptive efficacy of other methods of hormonal contraception,
including the combined OC14, progestin implants154, and the
vaginal contraceptive ring, may also be influenced by body
weight.
MECHANISM OF ACTION
The mechanism of action is similar to that of the combined
OC. The contraceptive patch suppresses follicular development
and inhibits ovulation.155 Other mechanisms of action may
include the development of endometrial atrophy making the
endometrium unreceptive to implantation and cervical mucus
changes that impede sperm transport.
THE TRANSDERMAL CONTRACEPTIVE PATCH
INDICATIONS
INTRODUCTION
In the absence of contraindications, the contraceptive patch may
be considered for any woman seeking a reliable, reversible, coitally independent method of contraception. It may be especially
The contraceptive patch was approved for use in Canada in
2002 and became available for use in January of 2004. The
Table 2. Drug Interactions With Oral Contraceptives (OCs)
Medications Whose Action May
Cause Contraceptive Failure
Medications Which May Increase
OC Activity
Carbamazepine
Griseofulvin
Oxcarbazepine
Phenobarbitol
Phenytoin
Primidone
Rifampin
Ritonavir
St. John’s Wort
Topiramate
Acetaminophen
Erythromycin
Fluoxetine
Fluconazole
Fluvoxamine
Grapefruit juice
Nefazadone
Vitamin C
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Medications Whose Clearance Can
Be Decreased by OCs
Amitriptyline
Caffeine
Cyclosporine
Diazepam
Imipramine
Phenytoin
Selegiline
Theophylline
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reported breast symptoms are either mild or moderate (86%)
and tend to decrease with continued patch use, down to 0% of
patients at 13 months.138 Only 1.9% of patients discontinued
patch use due to breast symptoms.156 Headaches led to patch
discontinuation in 1.1% of study patients.156
suited for women seeking a less compliance-demanding method
of contraception.
The use of condoms is still recommended in contraceptive
patch users for protection against STIs and HIV.
CONTRAINDICATIONS
3. LOCAL SKIN REACTION
Contraindications to use of the contraceptive patch are similar
to those for the combined oral contraceptive pill. These include
current or past history of venous thromboembolism; cerebrovasuclar or coronary disease; complicated valvular heart disease; severe hypertension; diabetes with end-organ involvement;
headaches with focal neurological symptoms; known or suspected breast cancer; undiagnosed genital bleeding; hepatic adenomas or carcinomas; acute or chronic hepatocellular disease
with abnormal liver functions; and known or suspected pregnancy. Although not an absolute contraindication, women with
a body weight of greater than or equal to 90 kg may find that
the contraceptive patch is less effective than in women with
lower body weights.153
Up to 20% of patients experience an application site
reaction.138,152,156 The frequency of application site reactions
did not increase over time.138 Most application site reactions
are mild to moderate in severity,156 and only 2% of patch users
discontinued it for this reason.138,156
RISKS
The risks are assumed to be the same as those known for the
combined OC.
MYTHS AND MISCONCEPTIONS
1. The patch won’t stay on during exercise; in hot, humid
weather; while swimming; or while in the shower.
Fact: The patch has excellent adhesive properties under a
wide range of conditions and climates (including bathing,
sauna and whirlpool use, treadmill activity, or cool-water
immersion).157 In clinical trials, approximately 1.9% of
patches required replacement due to complete detachment.138,152 Over time, the incidence of patch detachment
may decrease as the patch user becomes more familiar with
the application technique. Despite the fact that detachment
is rare, patch users should be advised to check daily to ensure
that their patch is adequately attached.
2. Women are more likely to be compliant with the patch if
they are older.
Fact: In a randomized, controlled study comparing patch
users to combined OC users, a significantly higher proportion of patch users had perfect compliance when compared
to the combined OC users (88.2% versus 77.7%).138 Compliance was improved across all of the age groups in comparison to the combined OC, but especially in the younger
women (aged 18–24). Perfect compliance rates in younger
women using the patch were 88% versus 68% to 74% perfect compliance rates for the combined OC group.
3. Because of the transdermal delivery system, the patch will
have less effect on the lipid profile than the combined oral
contraceptive pill.
Fact: An increase in serum total cholesterol and triglyceride
levels is seen in users of both the patch and the combined
OC.138,156
4. Because the patch is a hormonal method of contraception,
women who use the patch will gain weight.
Fact: There does not appear to be an association between the
NON-CONTRACEPTIVE BENEFITS
Cycle control has been shown to be comparable to that seen
with the combined OC.138,152-153 Although non-contraceptive
benefits are assumed to be similar to those seen with the combined OC, these potential benefits have not been assessed in
studies to date.
SIDE EFFECTS
With the exception of application site reactions, the side-effects
experienced by contraceptive patch users are similar to those
experienced by combined OC users.
1. IRREGULAR BLEEDING/SPOTTING
Overall, the incidence of breakthrough bleeding and spotting is
similar to that seen with combined OC users; although for cycles
1 and 2, patch users have significantly higher rates of spotting
(18.3% of patch users compared to 11.4% of combined OC
users).138 Subsequent cycles showed no significant difference
between patch users and combined OC users. The incidence of
breakthrough bleeding or spotting tends to decrease with
time.138,152-153 Amenorrhea with the contraceptive patch is rare.152
2. BREAST SYMPTOMS AND HEADACHE
Breast symptoms (including discomfort, engorgement, or pain)
and headache are the most common side effects reported with
patch use in pooled analysis (22% and 21% of users).156 Breast
symptoms are more common with the patch than with the
combined OC in the first 2 cycles of patch use; but by cycle 3,
there is no significant difference between the 2 groups. Most
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than 24 hours, the woman should attempt to reattach the patch.
If this is not successful, a new patch should be applied. The
patch change day would remain the same. If the patch has been
completely or partially detached for more than 24 hours or the
timing is uncertain, a new patch should be applied and a new
cycle started. Back-up contraception should be used for 1 week.
contraceptive patch and weight gain when investigated and
compared to placebo.158 In a pooled analysis of patch users,
78.5% of patients remained within 5% of their baseline
weight while using the contraceptive patch.156
INITIATION
A “first-day start,” when the patch is applied on the first day of
menses, is recommended. This will be the “Patch Change Day.”
If the patch is applied after the first day of menses, a backup
method of contraception should be used for 1 week. A new patch
is applied weekly for 3 weeks including the week in which the
patch is started; week 4 is patch-free. Withdrawal bleeding usually occurs during the patch-free week. It is recommended that
the patch always be applied on the same day, e.g. on a Monday.
The patch should be applied to clean, dry, healthy, intact
skin. The patch may be applied at 1 of 4 sites: the buttock; the
abdomen; the upper outer arm; or the upper torso, but not
directly to the breast. These 4 sites are therapeutically equivalent.159 Patch users should be advised to check daily that their
patch is adhering well.
A follow-up appointment should be made to assess the
patch users’ satisfaction with the method, to discuss any sideeffects, to ensure that it is being used correctly, and to answer
questions. If indicated, a pelvic examination can be performed
at the follow-up visit.
2. PATCH APPLICATION, CHANGE, OR REMOVAL IS
FORGOTTEN
If the patch user forgets to apply the patch in week 1, the patch
user should apply a new patch as soon as she remembers. Backup contraception is recommended for 1 week. The patch user
then has a new patch change day; although if she prefers to keep
the same patch change day, that is an acceptable option.
If the patch user forgets to change the patch in week 2 or
3, the recommended course of action depends on how late the
user is in changing the patch. The patch can maintain target
hormonal serum concentrations through 9 full days of use.160
For this reason, if the patch user is less than 48 hours late in
changing her patch, she should change it immediately; she will
not require backup contraception. The patch change day does
not change. If however, she is more than 48 hours late in
changing her patch, a new 4 week cycle should be started
immediately by applying a new patch. She will have a new
patch change day and will need to use backup contraception
for 1 week.
If the patch user forgets to remove the patch in week 4, the
old patch should be removed as soon as it is remembered. The
next patch is applied on the usual patch change day. Back-up
contraception is not required if there is less than a 7 day patchfree interval. The patch-free interval should never exceed
7 days.
SWITCHING FROM THE COMBINED OC TO THE
CONTRACEPTIVE PATCH
The contraceptive patch should be applied on the first day of
withdrawal bleeding. If the patch is started after the first day of
withdrawal bleeding, a backup method of contraception should
be used for 7 days. If more than 5 days have elapsed since the
last hormone-containing pill was taken, a backup method of
contraception should be used for the first 7 days of patch use.
Alternatively, the patch can be applied on the day after the
last hormonal pill is taken. In this case, there would be no
hormone-free interval. Back-up contraception would not be
needed in this case and the patient would not experience a menstrual bleed in that month.
3. CHANGING THE PATCH-CHANGE DAY
A new cycle should be started by placing the first patch of the
new cycle on the new desired patch change day during the patchfree week. The patch-free interval should not exceed 7 days.
DRUG INTERACTIONS
Pharmacokinetic studies have shown no significant interaction
between tetracycline and the contraceptive patch.151 Other drug
interactions have not been specifically studied and, at this time,
drug interactions that are reported with the combined OC are
assumed also to occur with the contraceptive patch.
SWITCHING FROM DEPOTMEDROXYPROGESTERONE ACETATE (DMPA)
TO THE CONTRACEPTIVE PATCH
The first contraceptive patch should be applied on the day that
the next DMPA injection would be due. If given at this time,
backup contraception is not required.
THE VAGINAL CONTRACEPTIVE RING
TROUBLESHOOTING
INTRODUCTION
1. PATCH PARTIALLY OR COMPLETELY DETACHES
The vaginal contraceptive ring (NuvaRing) was approved by
the US Food and Drug Administration (FDA) in 2001 and
If the patch has either partially or completely detached for less
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became available in the US market in 2003. It has been submitted for approval in Canada. It is a flexible, nearly transparent
ring that is 54 mm in outer diameter and 4 mm in crosssectional diameter. The ring releases a constant rate of 15 µg of
ethinyl estradiol and 0.120 mg of the progestin etonogestrel per
day.161 Etonorgestrel is the active metabolite of desogestrel. Each
ring is used for 1 cycle and then removed. A cycle consists of 3
weeks of continuous ring use followed by a 1 week ring-free
interval.
NON-CONTRACEPTIVE BENEFITS
Although assumed to be similar for those seen with the combined OC, no studies have specifically addressed non-contraceptive benefits of the vaginal contraceptive ring.
SIDE-EFFECTS
Side-effects are similar to those seen for the combined OC,
although certain side-effects are obviously specific to the vaginal
ring.
EFFICACY
In several thousand cycles of use, the Pearl Index — with perfect use of the vaginal ring — is between 0.4 and 0.77.162,163
while the overall Pearl Index is between 0.65 and 1.18.162,163
Knowing that compliance may affect contraceptive efficacy,
compliance rates were calculated in studies. Perfect compliance
is seen in 85.6 to 91% of contraceptive ring users.162,163
1. IRREGULAR BLEEDING
Irregular bleeding occurs in up to 6.4% of cycles and usually
consists of spotting.162 Unlike other contraceptive methods,
irregular bleeding does not appear to be significantly higher in
the first cycles of ring use. When compared to the combined
OC, the vaginal ring has significantly less irregular bleeding,
most notably in the first cycle of use.167 Withdrawal bleeding
occurs in the majority of cycles.162
MECHANISM OF ACTION
The mechanism of action is similar to that of the combined
OC. The vaginal contraceptive ring suppresses follicular
development and inhibits ovulation.164,165 Other mechanisms of action may include the development of endometrial atrophy making the endometrium unreceptive to
implantation and cervical mucus changes that impede sperm
transport.166
2. HORMONAL SIDE-EFFECTS
Headache (11.8%), nausea (4.5%), and breast tenderness
(2.8%) are the most common reported hormonal side-effects
occurring in ring users.162
3. VAGINAL SYMPTOMS
Vaginitis is the most commonly reported local side-effect,
occurring in 13.7% of users, although only 5.3% of cases were
felt to be treatment-related.162 Treatment-related leukorrhea
occurs in approximately 5% of women.162 Although women
or their partners may be aware of the device, only 1 to 2.5%
of ring users discontinued the ring due to foreign body sensation, coital problems, or expulsion. Vaginal symptoms of discharge and irritation led to discontinuation in about 1 to 2%
of women.162
INDICATIONS
In the absence of contraindications, the vaginal contraceptive
ring can be considered for any woman seeking a reliable,
reversible, coitally independent method of contraception. It may
be particularly suited for women who prefer a method of contraception that does not require daily attention.
The use of condoms is still recommended in vaginal contraceptive ring users for protection against STIs and HIV.
RISKS
CONTRAINDICATIONS
The risks are felt to be the same as for oral contraceptives.162
Contraindications to use of the vaginal ring are similar to those
for the combined OC. These include: pregnancy or suspected
pregnancy; current or past venous thromboembolism; cerebrovascular or coronary artery disease; complicated valvular
heart disease; severe hypertension; diabetes with end-organ
involvement; headaches with focal neurological symptoms;
known or suspected carcinoma of the breast, endometrium,
or cervix; unexplained vaginal bleeding; or an allergic reaction
to any of the components of the rings.
Relative contraindications include uterovaginal prolapse or
vaginal stenosis if they prevent retention of the ring.
INITIATION
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The ring is used vaginally. The first ring cycle is started
between day 1 and day 5 of the menstrual cycle. The ring is
inserted and left in place for 3 weeks and then removed for 1
week. Withdrawal bleeding usually occurs during the ring-free
interval.163 The ring-free interval should be no longer than 7
days. To switch from the combined OC to the vaginal ring,
the ring should be inserted no later than 7 days after the last
combined OC tablet. To switch from a progestin-only pill,
the vaginal ring is inserted the day after the last pill is taken.
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MARCH 2004
When switching from an injectable contraceptive method, the
ring is inserted on the day when the next injection would be
due.
COMBINED INJECTABLE CONTRACEPTION
A monthly injectable contraceptive composed of 5 mg estradiol cypionate and 25mg medroxyprogesterone acetate (Lunelle)
was approved by the FDA in October 2000 for use in the United States. As of January 2004, it has not been submitted for
approval in Canada. It is administered by intramuscular injection, with no more than 33 days between injections. In a study
of 782 American women followed over 1 year, there were no
pregnancies.169 Its mechanism of action is primarily by inhibition of ovulation.170 It has the same indications and contraindications as combined oral contraceptive pills. This method should
be considered for women who have difficulty remembering to
take daily pills, who want monthly predictable bleeding, or have
enteric absorption problems (e.g., inflammatory bowel disease).
When compared with DMPA, the combined monthly
injectable has more frequent injections (every 28 ± 5 days), and
faster return to ovulation. The first normal ovulatory cycle
occurs 63 to 112 days following the last injection after 3 monthly injections of Lunelle.170 The vaginal bleeding with this
method is due to estrogen withdrawal, and usually occurs 3
weeks (day 22) after the injection.171
When compared with combined OCs, the combined
monthly injectable has less breakthrough bleeding171, a greater
incidence of amenorrhea (14.6% during at least 1 cycle over
1 year, compared with 3.3% for OC users [p ≤ 0.01] )171, better
inhibition of ovarian follicular activity than a 20 µg ethinyl estradiol pill,172 and a weight gain of about 4 pounds over 1 year.173
TROUBLESHOOTING
If the ring is expelled and has been out of the vagina for less than
3 hours, the user should rinse the ring in lukewarm water and
reinsert it. Back-up contraception is not required. If the ring is
lost, a new ring should be inserted. If it is out of the vagina for
longer than 3 hours, a back-up method of contraception should
be used for 7 days.
If the ring remains in the vagina for more than 3 weeks (but
less than 4 weeks total), it is still effective in preventing pregnancy.161 The ring should be removed and a new ring inserted
after a 1-week ring-free break. If however, the ring has been left
in place for more than 4 weeks, it may no longer provide adequate protection against pregnancy. Consideration should be
given to the use of emergency contraception and a backup
method of contraception should be used until a new ring has
been in place for at least 7 days.
DRUG INTERACTIONS
In one study, vaginal spermicide use was not found to have any
short-term or long-term effects on the efficacy of the vaginal
ring.168 Vaginally administered miconazole was not found to
have a significant effect on serum concentrations of ethinyl
estradiol or etonogestrel.168 For more information about spermicides please refer to chapter 8. Until further research is available, other drug interactions are considered similar to those seen
with combined OCs.
SUMMARY STATEMENTS
1. To date, no single low-dose combined oral contraceptive
New Oral Contraceptives To Be Launched
Cyclessa (Organon)
Cyclessa (desogestrel/ethinyl estradiol) is a triphasic oral contraceptive with 25 micrograms of estrogen (ethinyl
estradiol).
Cyclessa prevents pregnancy by inhibiting ovulation. Cyclessa is designed to reduce women’s overall exposure
to hormones while maintaining contraceptive efficacy. Cyclessa consists of 25µg of estrogen per day for 21
days. The daily progestin dose is 100µg of desogestrel for days 1 to 7, 125µg for days 8 to 14, and 150µg for
days 15 to 21. Cyclessa’s dosing regimen reduces hormone exposure to both estrogen and progestin during the
21-day course. The last 7 days of the cycle contains placebo pills.
Mircette (Organon)
Mircette is a 28-day regimen combined oral contraceptive with a unique dosing schedule: 20µg ethinyl estradiol
and 150µg desogestrel for 21 days, followed by 2 days of placebo tablets and 5 days of low-dose estrogen
tablets containing just 10µg ethinyl estradiol. It therefore has a shortened hormone-free interval of 2 days,
instead of the typical 7 days of most other pills.
Mircette has been available in the U.S. since July 1998 and is currently being reviewed by Health Canada.
Yasmin (Berlex Canada)
Yasmin is a monophasic combined OC with a new progestin. Each tablet contains 3mg drospirenone (DRSP) and
30µg ethinylestradiol. Drospirenone belongs to an entirely new class of progestin. It is an analogue of
spironolactone. It possesses antimineralocorticoid activity that may help to suppress estrogen related fluid
retention. The product has been launched in several major countries including the US. Germany was the first to
launch Yasmin in November 2000. Health Canada is currently reviewing Yasmin.
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MARCH 2004
2.
3.
4.
5.
6.
11. Fu H, Darroch JE, Haas T, Ranjit N. Contraceptive failure rates: new estimates from the 1995 National Survey of Family Growth. Fam Plann Perspect 1999;31:56–63.
12. Potter L, Oakley D, de Leon-Wong E, Canamar R. Measuring compliance
among oral contraceptive users. Fam Plann Perspect 1996;28(4):154–8.
13. Rosenberg MJ,Waugh MS, Burnhill MS. Compliance, counseling and satisfaction with oral contraceptives: a prospective evaluation. Fam Plann
Perspect 1998;30(2):89–92.
14. Holt VL, Cushing-Haugen KL, Daling JR. Body weight and risk of oral
contraceptive failure. Obstet Gynecol 2002;99(5):820–7.
15. Vessey M. Oral contraceptive failures and body weight: findings in a large
cohort study. J Fam Plann Reprod Health Care 2001;27(2):90–1.
16. Diczfalusy E. Probable mode of action of oral contraceptives. Res
Steroids 1966;2:389–92.
17. Mitra PK, Roychadhuri J. Effect of oral contraceptives on the ultrastructure of the endometrium. J Gynaecol Endocrinol 1987;3(1-4):13–5.
18. Rossmanith WG, Steffens D, Schramm G. A comparative randomized
trial on the impact of two low-dose oral contraceptives on ovarian
activity, cervical permeability, and endometrial receptivity. Contraception
1997;56(1):23–30.
19. Larsson G, Milsom I, Lindstedt G, Rybo G.The influence of a low-dose
combined oral contraceptive on menstrual blood loss and iron status.
Contraception 1992;46(4):327–34.
20. Iyer V, Farquhar C, Jepson R. Oral contraceptive pills for heavy menstrual
bleeding (Cochrane Methodology Review). In:The Cochrane Database
of Systematic Reviews, Issue 4 2003.
21. Berenson AB, Radecki C, Grady JJ, et al. A prospective, controlled study
of the effects of hormonal contraception on bone mineral density.
Obstet Gynecol 2001;98(4):576–82.
22. Petitti DB, Piaggio G, Mehta S, Cravioto MC, Meirik O. Steroid hormone
contraception and bone mineral density: a cross-sectional study in an
international population.The WHO Study of Hormonal Contraception
and Bone Health. Obstet Gynecol 2000;95(5):736–44.
23. Gambacciani M, Spinetti A,Taponeco F, Cappagli B, Piaggesi L, Fioretti P.
Longitudinal evaluation of perimenopausal vertebral bone loss: effects of
a low-dose oral contraceptive preparation on bone mineral density and
metabolism. Obstet Gynecol 1994;83(3):392–6.
24. Kritz-Silverstein D, Barrett-Connor E. Bone mineral density in
postmenopausal women as determined by prior oral contraceptive use.
Am J Public Health 1993;83:100–2.
25. Hendrix SL, Alexander NJ. Primary dysmenorrhea treatment with a
desogestrel-containing low-dose oral contraceptive. Contraception
2002;66(6):393–9.
26. Milsom I, Sundell G, Andrersch B.The influence of different combined
oral contraceptives on the prevalence and severity of dysmenorrhea.
Contraception 1990;42(5):497–506.
27. Sundell G, Milsom I, Andersch B. Factors influencing the prevalence and
severity of dysmenorrhoea in young women. Br J Obstet Gynaecol
1990;97:588–94.
28. Casper RF, Dodin S, Reid RL.The effect of 20mcg ethinyl estradiol/1 mg
norethindrone acetate (Minestrin), a low-dose oral contraceptive, on
vaginal bleeding patterns, hot flashes, and quality of life in symptomatic
perimenopausal women. Menopause 1997;4:139–47.
29. Shargril AA. Hormone replacement therapy in perimenopausal women
with a triphasic contraceptive compound: a three year prospective
study. Int J Fertility 1985;30(15):18–28.
30. Redmond GP, Olson WH, Lippman JS, Kafrissen ME, Jones TM, Jorizzo JL.
Norgestimate and ethinyl estradiol in the treatment of acne vulgaris: a
randomized, placebo-controlled trial. Obstet Gynecol 1997;89(4):
615–22.
31. Lemay A, Poulin Y. Oral contraceptives as anti-androgenic treatment of
acne. J Obstet Gynaecol Can 2002;24(7):559–67.
32. Thiboutot D, Archer DF, Lemay A,Washenik K, Roberts J, Harrison DD.
A randomized, controlled trial of a low-dose contraceptive containing
20 microg of ethinyl estradiol and 100 microg of levonorgestrel for acne
treatment. Fertil Steril 2001;76(3):461–8.
33. Lucky AW, Henderson TA, Olson WH, Robisch DM, Lebwohl M,
Swinyer LJ. Effectiveness of norgestimate and ethinyl estradiol in treating
(OC) preparation has demonstrated unequivocal clinical
superiority. Therefore, user preferences and individual
response are the basis for choosing a particular preparation.
(Level 1)
The use of monophasic combined OC preparations continuously for several cycles, without periodic withdrawal, is a
reasonable approach to the management of severe dysmenorrhea, menorrhagia, menstrual migraine, or where there is
a desire or need to postpone withdrawal bleeding. (Level 1,
Level II-2)
Combined OC use reduces the risk of developing cancer of
the ovary and cancer of the endometrium, and does not increase the overall risk of developing breast cancer. (Level II-2)
Use of low-dose combined OCs increases the risk of venous
thromboembolism 3- to 4-fold. Because VTE is rare in
women of childbearing age, this increase in risk has minimal
clinical significance in women without additional risk factors for VTE. (Level II-2)
Potential differences in risk of VTE or myocardial infarction
attributable to different preparations of combined OCs do
not currently justify differential prescribing. (Level III)
A pelvic examination is an important part of well woman
care, but it is not a prerequisite for providing hormonal contraception or emergency contraception. (Level III)
RECOMMENDATIONS
1. A range of hormonal contraceptives should be available
to ensure that the individual receives the preparation
most suited for her needs. (Grade C)
2. Women using oral contraceptives should be counselled that
antibiotic use does not appear to affect combined OC efficacy (except for griseofulvin and rifampicin). (Grade B)
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Westhoff C, Morroni C, Kerns J, Murphy PA. Bleeding patterns after
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cycle oral contraceptive. Contraception 2003;68(2):89–96.
126. Rutter W, Knight C,Vizzard J, Mira M, Abraham S.Women’s attitudes to
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127. den Tonkelaar, Oddens B. Preferred frequency and characteristics of
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128. Cachrimanidou AC, Hellberg D, Nilsson S,Waldenstrom U, Olsson SE,
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129. Hamerlynck J,Vollebregt J, Doomebos C, Muntendam P. Postponement
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130. Ziaei S, Rajaei L, Faghihzadeh S, Lamyian M. Comparative study and evaluation of side effects of low-dose contraceptive pills administered by
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131. Coutinho EM, Mascarenhas I, de Acosta OM, Flores JG, Gu ZP, Ladipo
OA, et al. Comparative study on the efficacy, acceptability, and side
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132. Coutinho EM, de Souza JC, da Silva AR, de Acosta OM, Alvarez F,
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133. Coutinho EM, O’Dwyer E, Barbosa IC, Gu ZP, Shaaban MM, AboulOyoon M, et al. Comparative study on intermittent versus continuous
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134. Souka AR, el Sokkary H, Hassan M.The effect of vaginal administration
of low-dose oral contraceptive tablets on human ovulation. Contraception 1986;33(4):365–71.
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estradiol and dl-norgestrel. Fertil Steril 1984;42(3):478–81.
136. Coutinho EM, Silva AR, Carreira C, Barbosa I. Ovulation inhibition following vaginal administration of pills containing norethindrone and mestranol. Contraception 1984;29(2):197–202.
137. Schilling LH, Bolding OT, Chenault CB, Chong AP, Fleury F, Forrest K,
et al. Evaluation of the clinical performance of the triphasic oral contraceptives: a multicenter, randomized, comparative trial. Am J Obstet
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138. Audet MC, Moreau M, Koltun WD,Waldbaum AS, Shangold G,
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139. Rosenberg MJ,Waugh MS, Higgens JE.The effect of desogestrel, gestodene, and other factors on spotting and bleeding. Contraception
1996;53:85–90.
140. Rosenberg MJ,Waugh MS. Smoking and cycle control among oral contraceptive users. Am J Obstet Gynecol 1996;174(2):628–32.
141. Krettek JE, Arkin SI, Chaisilwattana P, Monif GR. Chlamydia trachomatis
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142. Rosenberg MJ, Meyers A, Roy V. Efficacy, cycle control, and side effects of
low- and lower-dose oral contraceptives: a randomized trial of 20 [mu]g
and 35 [mu]g estrogen preparations. Contraception 1999;60(6):321–9.
143. Bracken MB. Oral contraception and congenital malformations in
offspring: a review and meta-analysis of the prospective studies. Obstet
Gynecol 1990;76(3 Pt 2):552–7.
144. D’Arcy PF. Drug interactions with oral contraceptives. Drug Intell Clin
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145. Fotherby K. Interactions with oral contraceptives. Am J Obstet Gynecol
1990;163:2153–9.
146. Oesterheld JR. Gynecology: oral contraceptives. In: Cozza KL,
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147. Crawford P, Chadwick DJ, Martin C,Tjia J, Back DJ, Orme M.The interaction of phenytoin and carbamazepine with combined oral contraceptive steroids. Br J Clin Pharmacol 1990;30:892–6.
148. Dickinson BD, Altman RD, Nielsen H, Sterling ML. Drug interactions
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149. Hachad H, Ragueneau-Majlessi I, Levy RH. New antiepileptic drugs:
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150. Schwarz UI, Buschel B, Kirch W. Unwanted pregnancy on selfmedication with St John’s wort despite hormonal contraception. Br J
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151. Abrams LS, Skee DM, Natarajan J,Wong FA. Pharmacokinetic overview
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152. Smallwood GH, Meador ML, Lenihan JP, Shangold GA, Fisher AC,
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of a transdermal contraceptive system. Obstet Gynecol
2001;98:799–805.
153. Zieman M, Guillebaud J,Weisberg E, Shangold G, Fisher AC, Creasy GW.
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(2 Suppl 2):S13–S18.
154. Gu S, Sivin I, Du M, Zhang L, et al. Effectiveness of Norplant implants
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155. Pierson RA, Archer DF, Moreau M, Shangold GA, Fisher AC, Creasy
GW. Ortho Evra™/Evra™ versus oral contraceptives: follicular development and ovulation in normal cycles and after an intentional dosing
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156. Sibai BM, Odlind V, Neador ML, Shangold G, Fisher AC, Creasy GW.
A comparative and pooled analysis of the safety and tolerability of the
contraceptive patch. Fertil Steril 2002;77(2 Suppl 2):S19–S26.
157. Zacur HA, Hedon B, Mansour D, Shangold G, Fisher AC. Integrated
summary of ortho evra/evra contraceptive patch adhesion in varied climates and conditions. Fertil Steril 2002;77(2 Suppl 2):S32–S35.
158. Gallo MF, Grimes DA, Schulz KF, Helmerhorst FM. Combination contraceptives: effects on weight (Cochrane Review). In:The Cochrane Library,
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159. Abrams LS, Skee DM, Natarajan J,Wong FA, Anderson GD. Pharmacokinetics of a contraceptive patch (Evra/Ortho Evra) containing norelgestromin and ethinyloestradiol at four application sites. Br J Clin
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160. Abrams LS, Skee DM,Wong FA, Anderson NJ, Leese PT. Pharmacokinetics of norelgestromin and ethinyl estradiol from two consecutive contraceptive patches. J Clin Pharmacol 2001;41(11):1232–7.
161. Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and
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162. Roumen FJ, Apter D, Mulders TM, Dieben TO. Efficacy, tolerability and
acceptability of a novel contraceptive vaginal ring releasing etonogestrel
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163. Dieben TO, Roumen FJ, Apter D. Efficacy, cycle control, and user acceptability of a novel combined contraceptive vaginal ring. Obstet Gynecol
2002;100(3):585–93.
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164. Mulders TM, Dieben TO. Use of the novel combined contraceptive
vaginal ring NuvaRing for ovulation inhibition. Fertil Steril
2001;75(5):865–70.
165. Mulders TM, Dieben TO, Bennink HJ. Ovarian function with a novel
combined contraceptive vaginal ring. Hum Reprod 2002;17(10):2594–9.
166. Killick S. Complete and robust ovulation inhibition with NuvaRing. Eur J
Contracept Reprod Health Care 2002;7:13–8.
167. Bjarnadottir RI,Tuppurainen M, Killick SR. Comparison of cycle control
with a combined contraceptive vaginal ring and oral levonorgestrel
/ethinyl estradiol. Am J Obstet Gynecol 2002;186(3):389–95.
168. Alexander NJ, Haring T, Mulders TM. A pharmacokinetic interaction
study of NuvaRing and a vaginally administered spermicide or antimycotic [abstract 0-63]. Fertil Steril 2002;78(Suppl 1):S24–5.
169. Kaunitz AM, Garceau RJ, Cromie MA. Comparative safety, efficacy, and
cycle control of Lunelle monthly contraceptive injection
(medroxyprogesterone acetate and estradiol cypionate injectable
suspension) and Ortho-Novum 7/7/7 oral contraceptive
(norethindrone/ethinyl estradiol triphasic). Contraception
1999;60(4):179–87.
170. Rahimy MH, Ryan KK. Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension):
assessment of return of ovulation after three monthly injections in surgically sterile women. Contraception 1999;60(4):189–200.
171. Garceau RJ,Wajszczuk CJ, Kaunitz AM. Bleeding patterns of women
using Lunelle monthly contraceptive injections (medroxyprogesterone
acetate and estradiol cypionate injectable suspension) compared with
those of women using Ortho-Novum 7/7/7 (norethindrone/ethinyl
estradiol triphasic) or other oral contraceptives. Contraception
2002;62(6):289–95.
172. Jain JK, Ota F, Mishell DR. Comparison of ovarian follicular activity during treatment with a monthly injectable contraceptive and a low-dose
oral contraceptive. Contraception 2000;61(3):195–8.
173. Kaunitz AM, Garceau RJ, Cromie MA. Comparative safety, efficacy, and
cycle control of Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) and
Ortho-Novum 7/7/7 oral contraceptive (norethindrone/ethinyl estradiol triphasic). Lunelle Study Group. Contraception 1999;60(4):179-87.
EFFICACY
DMPA is a highly effective form of contraception, with a failure rate of less than 0.3 % per year.2-6
MECHANISM OF ACTION
DMPA works primarily by inhibiting the secretion of pituitary
gonadotropins, thereby suppressing ovulation.7 It increases the
viscosity of cervical mucus8 and induces endometrial atrophy.2
INDICATIONS
In the absence of contraindications, DMPA may be considered
for any woman seeking a reliable, reversible, coitally independent
method of contraception. It does not require daily attention and
therefore may be more suitable for women who have difficulty
complying with other birth control methods. It may be used by
women who require an estrogen-free method of contraception or
for those who wish to take advantage of its non-contraceptive
benefits. It may be suitable for the following women:
• women with known contraindications or sensitivity to estrogen
• women over the age of 35 who smoke
• women with migraine headaches
• women who are breastfeeding
• women with endometriosis
• women with sickle cell disease
• women taking anti-convulsant medications
The use of condoms is still recommended in DMPA users
for protection against sexually transmitted infections (STIs) and
human immunodeficiency virus (HIV) infection.
CHAPTER 5: PROGESTIN-ONLY HORMONAL
CONTRACEPTION
CONTRAINDICATIONS
Amanda Black, MD, FRCSC,1 Teresa O’Grady, MD,
FRCSC,2 Helen Pymar, MD, MPH, FRCSC3
The World Health Organization (WHO) has developed a list
of absolute and relative contraindications to the use of DMPA
based on the available evidence of risks.6 Absolute contraindications include pregnancy (known or suspected), unexplained
vaginal bleeding, and current diagnosis of breast cancer. Relative contraindications include severe cirrhosis, active viral hepatitis, and benign hepatic adenoma.
1Ottawa
ON
2St. John’s NL
3Toronto ON
INTRODUCTION
Progestin-only contraception may be provided in injectable
form, as oral medication, or as an implant. Currently, only the
injectable and the oral forms are available in Canada.
NON-CONTRACEPTIVE BENEFITS
DMPA use is a reliable method of contraception, and it also has
a number of non-contraceptive benefits. These include
• amenorrhea with subsequent reduction in dysmenorrhea
and anemia (The rate of amenorrhea is 55 to 60% at 12
months and 68% at 24 months.)3,9-11
• reduced risk of endometrial cancer12
• reduction in symptoms associated with endometriosis,13,14
premenstrual syndrome, and chronic pelvic pain15
INJECTABLE PROGESTIN
Depot medroxyprogesterone acetate (DMPA) has been used as
a contraceptive agent since 1967 and is extensively used by millions of women in over 90 countries. It was approved for contraceptive use in Canada in 1997. Approximately 2% of
Canadian women use DMPA for birth control.1
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• decreased incidence of seizures16
• possible reduced risk of pelvic inflammatory disease17,18
• possible decreased incidence of sickle cell crisis.19
ity after the last injection.7,28,29 The rate of conception 10
months after the last DMPA injection is 50%, and approximately 90% by 24 months.7
SIDE EFFECTS
2. REDUCTION IN BONE MINERAL DENSITY (BMD)
Although some cross-sectional studies have demonstrated no
adverse effect of DMPA on bone mineral density,30,31 the majority of studies report a decrease in BMD in DMPA users.32-37
Prospective studies have found a mean loss of BMD at the lumbar spine of between 0.87% and 3.52%.35,36,37 Although a
decrease in BMD has been observed, it does not appear to
induce osteoporosis. Furthermore, two cross-sectional studies
of past DMPA users38,39 did not demonstrate a measurable difference in BMD compared with controls, suggesting that there
is an improvement in BMD after DMPA is discontinued. A
prospective cohort study36 reported a substantial recovery of
BMD once DMPA was discontinued. One randomized, double-blind controlled trial suggested that supplemental oral estrogen may attenuate the negative effects of DMPA on BMD.40
Larger, long-term prospective studies in current and past users
of DMPA are required to evaluate BMD changes further.
1. MENSTRUAL CYCLE DISTURBANCE
The most common side effect associated with DMPA use is the
disruption of menstrual patterns. Irregular bleeding or unwanted amenorrhea may lead to discontinuation of DMPA.9 In large
studies of DMPA users, unpredictable bleeding was common
in the first few months of use but decreased in amount and frequency with time. Abnormally heavy or prolonged bleeding
occurred in only 1 to 2% of users.3,20 At 12 months, 55 to 60%
of DMPA users are amenorrheic, and by 24 months up to 68%
are amenorrheic.3,9-11,20
2. HORMONAL SIDE EFFECTS
Reported hormonal side effects with use of DMPA include
headache, acne, decreased libido, nausea, and breast tenderness.
Headache is the most common non-bleeding side effect reported by DMPA users, occurring in approximately 17% of DMPA
users.3,21 Migraine headaches do not constitute a contraindication to DMPA use.6
3. VENOUS THROMBOEMBOLISM (VTE),
CARDIOVASCULAR DISEASE, STROKE
When used in standard contraceptive doses, DMPA does not
appear to increase the risk of VTE,41,42 but only limited data
are available. DMPA users do not appear to have an increased
risk of cardiovascular disease, stroke, or myocardial infarction.41
3. WEIGHT GAIN
In one study, 56% of DMPA users reported an increase in
weight (mean gain of 4.1 kg), while 44% either lost weight or
maintained their baseline weight (mean loss of 1.7 kg).9 Other
studies have failed to find an effect of DMPA on weight.22-24
Weight gain associated with DMPA use is thought to be due to
appetite stimulation25 and a possible mild anabolic effect. The
product monograph suggests the following average weight gains
in DMPA users: 2.5 kg in the first year of use, 3.7 kg after the
second year of use, and 6.3 kg after the fourth year of use.
DMPA users should be given counselling regarding healthy eating and exercise.
MYTHS AND MISCONCEPTIONS
1. DMPA administered inadvertently during pregnancy is associated with birth defects.
Fact: There is no evidence that fetuses exposed to DMPA in
utero are at an increased risk of congenital anomalies.43,44
2. All DMPA users will gain weight.
Fact: Although DMPA users may gain weight, a significant
percentage of patients will not gain weight while using
DMPA.9 Dietary counselling is advised.
3. DMPA should not be given to breastfeeding women.
Fact: DMPA has been shown to be an effective method of
postpartum contraception that has little or no effect on breast
milk production or on infant development.43,45-48
4. DMPA causes cancer.
Fact: DMPA is associated with a decreased risk of endometrial cancer.12 There does not appear to be an increased risk
of ovarian cancer49 or breast cancer.50-52 Studies suggest either
a slight or no increase in the risk of cervical cancer.52-56
4. MOOD EFFECTS
Although mood changes have been reported in DMPA users3
and may lead to discontinuation of DMPA, prospective studies do not appear to demonstrate an increase in depressive symptoms in DMPA users.26,27 This suggests that depression is not
a contraindication for DMPA use. Further studies are required
to determine if there is a causal link.
RISKS
1. DELAYED RETURN OF FERTILITY
Although DMPA is a reversible contraceptive method, there
may be a delay in the resumption of ovulation. DMPA users
have an average 9-month delay before restoration of full fertilJOGC
INITIATION
It is best to administer DMPA during the first 5 days of menses
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must continue to use a backup method of birth control and
have a repeat serum assay for βHCG performed in 2 weeks (the
serum assay for βHCG will not be positive until at least 8 days
post-conception). DMPA is not teratogenic if given inadvertently during pregnancy.46,47
in order to avoid inadvertent injection during pregnancy. If the
woman is switching from using a combined oral contraceptive
(OC) to DMPA, DMPA should be given within the first 5 days
of stopping the combined OC. DMPA is given as a 150 mg
intramuscular injection every 12 weeks. The injection may be
given in the deltoid or gluteus maximus muscles. If given within the first 5 days of the menstrual cycle, contraceptive effect is
achieved within 24 hours of injection.8,43 However, DMPA can
be given at any time during the menstrual cycle if pregnancy or
the possibility of pregnancy can be definitely ruled out. If given
after the first 5 days of the menstrual cycle, the woman should
be advised to use a backup method of birth control for at least
1 week.8,44
DRUG INTERACTIONS
Few medications will interact with DMPA. Aminoglutethimide48 and nevirapine have been shown to decrease the
effectiveness of DMPA.
ORAL PROGESTIN: PROGESTIN-ONLY PILL
Although not as well known or widely used as combined oral
contraceptives, progestin-only pills (POPs) used for contraception are very safe and highly effective when used as directed.
POPs are also known as “mini-pills.” In Canada, the POP is
supplied in packages of 28 tablets, each containing 0.35 mg of
norethindrone (Micronor).
FOLLOW UP
Follow-up visits should be scheduled every 12 weeks for repeat
injections. These follow-up visits allow for an assessment of
bleeding patterns and other potential side effects, an assessment
of patient satisfaction, and an opportunity to reinforce the issue
of condom use for protection against STIs and HIV infection.
EFFICACY
TROUBLESHOOTING
With perfect use, the POP has a failure rate of approximately
0.5%.2,6 Maximal effectiveness depends on consistent pilltaking. With typical use, the failure rate is between 5 and 10%.2,49
The failure rate appears to be lower in motivated women.50
1. MENSTRUAL CYCLE DISTURBANCE
If irregular bleeding persists after the first 6 months of use,
underlying causes of abnormal vaginal bleeding should be ruled
out. Once this has been done, management options include
• increasing the DMPA dose to between 225 and 300 mg
IM for 2 to 3 injections.
• decreasing the interval between doses.
• supplemental estrogen therapy, such as 0.625 mg of conjugated equine estrogen by mouth for 28 days, or 1 to
2 mg of estradiol-17β given by mouth for 28 days. Alternatively, supplemental estrogen therapy can be given
transdermally in the form of a 50 µg or 100 µg estradiol17β patch for a total of 25 days.
• administration of non-steroidal anti-inflammatory
agents, such as ibuprofen 400 to 800 mg twice daily for
a total of 10 days.
• adding a combined oral contraceptive pill for 1 to 3
months.45
MECHANISM OF ACTION
The chief mechanism of action in preventing pregnancy is
through alterations in the cervical mucus.51 POPs reduce the
volume of mucus, increase its viscosity, and alter its molecular
structure, resulting in little or no sperm penetration.52 In addition, sperm motility is impaired, making fertilization unlikely.53 Ovulation may be suppressed or partially suppressed.
Forty percent of women using progestin-only contraceptives
continue to ovulate.54 Endometrial changes, reducing the
potential for implantation, may occur.55 For maximal effectiveness, the POP must be taken at the same time every day.
INDICATIONS
In the absence of contraindications, the POP may be considered for any woman seeking a reliable, reversible, coitally independent method of contraception. It may be used by women
who require an estrogen-free method of contraception. For this
reason, it may be suitable for women over age 35 who smoke,
women who experience migraine headaches with neurological
symptoms, women who have unwanted side effects with use of
combined oral contraceptives, or women who are breastfeeding.
The use of condoms is recommended for POP users to
2. LATE INJECTION
If it has been less than 14 weeks since a woman’s last injection,
the next DMPA injection can be given. If it has been 14 or more
weeks since her last injection, but she has not had intercourse
within the last 10 days and she has a negative serum assay for
βHCG, the DMPA injection can be given. A backup method
of contraception should be used for 2 weeks. If she has had
intercourse within the last 10 days, the DMPA injection can be
given if the serum assay for βHCG is negative, although she
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strual cycle as long as pregnancy can be excluded. A pill containing the active hormone norethindrone is taken every day.
There is no pill-free interval. A backup method of birth control
should be used for the first 7 days. Contraceptive reliability
requires regular pill-taking at the same time each day (within 3
hours). Sperm penetration tests have shown that sperm permeability through cervical mucus increases if the interval between
POPs is longer than 24 hours.61
protect against sexually transmitted infections and infection
with the human immunodeficiency virus.
CONTRAINDICATIONS
The World Health Organization has developed a list of absolute
and relative contraindications to the use of POPs based on the
available evidence of risk.6 Absolute contraindications include
pregnancy and current breast cancer. Relative contraindications
include active viral hepatitis and liver tumours.
POSTPARTUM
In addition to providing an effective method of contraception,
the POP may decrease menstrual flow. Up to 10% of users will
develop amenorrhea. Menstrual cramping and premenstrual
symptoms may decrease.
There is a theoretical concern that progestins administered within the first 72 hours after delivery may interfere with the fall in
serum progesterone levels that triggers lactogenesis, thereby
interfering with breast milk production. However, a prospective study did not detect any adverse effect on breast-feeding
when progestin-only contraceptive methods were used within
the first 72 hours postpartum.59
SIDE EFFECTS
FOLLOW UP
NON-CONTRACEPTIVE BENEFITS
A follow-up visit should be scheduled. This allows for an assessment of bleeding patterns, an assessment of patient satisfaction,
and an opportunity to reinforce the issue of condom use for
protection against STIs and HIV. After this visit, a POP user
should continue annual well-woman care as for any sexually
active woman.
1. IRREGULAR BLEEDING
Irregular bleeding is the most frequently cited reason for discontinuation of the POP.50 Spotting occurs in approximately
12% of users in the first month, but this usually decreases to
less than 3% at 18 months. Forty percent of long-term users
continue to have regular cycles while using the POP.50
TROUBLESHOOTING
2. HORMONAL SIDE EFFECTS
Hormonal side effects such as headache, bloating, acne, and
breast tenderness occur less commonly.
1. IRREGULAR BLEEDING
Irregular bleeding is a common side effect of the POP. Pregnancy, infection, and genital pathology should be ruled out.
Once this has been done, treatment options include the use of
a non-steroidal anti-inflammatory agent for up to 10 days,
switching to a low-dose combined oral contraceptive pill, or
adding a short course of supplemental estrogen. Supplemental
estrogen therapy can be given orally as 0.625 mg of conjugated equine estrogen for 28 days or 1 to 2 mg of micronized estradiol-17β given for 28 days, or it may be given transdermally in
the form of a 50 µg or 100 µg estradiol-17β patch for a total of
25 days.
The use of anti-progestogenic agents has shown some success in the management of irregular bleeding associated with
progestin-only contraceptive methods.62,63 These agents, such
as mifepristone, are not currently available in Canada.
RISKS
Use of POPs is not associated with any major morbidity. Given
in contraceptive doses, the POP does not appear to increase the
risk of VTE, stroke, or myocardial infarction.41,42,56
MYTHS AND MISCONCEPTIONS
1. The POP can only be used by women who are breastfeeding.
Fact: Although the POP is safe to use in breastfeeding
women,57-60 it can be considered for any women seeking a
reliable, reversible contraceptive method.
2. The POP is not an effective method of birth control.
Fact: When used as directed, the POP is a safe and effective
method of birth control with a failure rate of approximately
0.5%.2,6
2. MISSED PILL
If a pill is missed, it should be taken as soon as possible. The
next pill should be taken at the regular time, even if it means
that 2 pills will be taken at the same time. If the pill use is
delayed by more than 3 hours, a backup method of birth control should be used for the next 48 hours.2 If 2 or more pills in
a row have been missed, then the individual must take 2 pills
INITIATION
The POP is usually started on the first day of the menstrual
cycle, although it may be started at any time during the menJOGC
239
MARCH 2004
per day for 2 days and use a backup method of birth control for
48 hours.
In the event of a missed or late pill, the use of emergency
contraception may be considered if appropriate. The healthcare provider may choose to provide an advance prescription
for emergency contraception for use in these circumstances.
The following chart compares the characteristics of 2 of the
newer devices with the 6-rod Norplant system:
Implanon, which contains etonogestrel as its active ingredient, differs from Norplant models because it appears to consistently inhibit ovulation until the beginning of the third year
of use.69 This appears to translate into higher amenorrhea rates
compared with levonorgestrel rod implant systems.71 The failure rate for Implanon is quite low, with no reported pregnancy
in a database that followed 70 000 cycles of use.72 Any pregnancies that have been reported with this method were felt to
have occurred before it was inserted.73 Pregnancies with Norplant (and Norplant-2) are felt to be lower than female sterilization for the first 5 years after insertion.74,75 Prolonged and
irregular vaginal bleeding are major reasons for discontinuation
of implant methods in all implant users and hence careful preinsertion counselling is essential.74
DRUG INTERACTIONS
Drug interactions with POPs are less well-known than are those
for combined oral contraceptives. The progestins used in POPs
are metabolized by the cytochrome P-450 enzyme system, and
any medication that will induce this system (such as certain anticonvulsants) may accelerate the metabolism of the POP and
reduce its contraceptive effectiveness.
PROGESTIN IMPLANTS
SUMMARY STATEMENTS
At one time, the 6-rod progestin implant called Norplant was
available in Canada. Norplant was a highly effective 5-year
method of reversible contraception with a failure rate of 0.1%
per year.64 Levonorgestrel was released from the 6 rods, thereby suppressing ovulation, inducing endometrial atrophy, and
rendering cervical mucus impermeable to sperm. Norplant was
removed from the market in Canada in September 2000
because a lower-than-expected hormonal release rate was noted
from several lots and there was a concern that contraceptive efficacy may have been affected.65 In July 2002, health-care professionals were informed that there did not appear to be a higher
failure rate from these lots, and women were advised that they
did not need to continue to use backup contraception. At the
same time, the company that manufactured Norplant stated
that it had no plans to reintroduce Norplant to the Canadian
or US markets.66 For those women who currently have Norplant in place, studies suggest that it remains effective in women
who weigh less than 70 kg for up to 7 years (Pearl Indices less
than 2 per 100 women-years).67,68
New progestin-only implants with fewer rods have been
developed and may become available in Canada in the future.
An implant system with fewer rods will have the advantage of
greater ease of insertion and removal. However, thorough training in insertion and removal of these implants is still extremely important to avoid injury to blood vessels, skin, and nerves.
1. Depot injections of medroxyprogesterone acetate (DMPA)
and progestin implants are the most effective hormonal
methods of contraception, and are appropriate contraceptive
choices for Canadian women. (Level II-1)
2. Use of progestin-only preparations has not been shown to
decrease breast milk production. The small amounts of
steroid hormones secreted into breast milk do not have an
adverse effect on the baby. (Level II-2)
3. The use of progestins given at contraceptive doses does not
appear to increase the risk of VTE, myocardial infarction, or
stroke. (Level II-2)
4. Progestin-only preparations may be appropriate contraceptive choices for women who have a past history of VTE.
Whether the use of progestin-only preparations in women
with a proven thrombophilia alters the risk of VTE is not
known. (Level III)
5. The use of DMPA in healthy young women is associated
with a decrease in bone mineral density that appears to be
reversible. There is no evidence that use of DMPA causes
osteoporosis. (Level II-1)
RECOMMENDATIONS
1. Progestin-only methods should be considered as contraceptive options for postpartum women, regardless of
Comparison of contraceptive implants
Characteristics
Number of Rods
Hormone
Length of rod
Diameter of rod
Amount of hormone
Duration of effectiveness 69,70
Implanon®
Norplant-2®
Norplant®
1
Etonorgestrel
4 cm
2 mm
68 mg
3 years
2
Levonorgestrel
4.3 cm
2.4 mm
75 mg (total 150 mg)
3–5 years
6
Levonorgestrel
3.4 cm
2.4 mm
36 mg (total 216 mg)
5–7 years
JOGC
240
MARCH 2004
breastfeeding status, and may be introduced immediately after delivery. (Grade B)
2. Progestin-only methods should be considered as contraceptive options for women with a past history of VTE,
or for women who are at a higher risk of myocardial
infarction or stroke. In women with a proven thrombophilia, progestin-only preparations should be used
with caution. (Grade B)
3. Young women who use DMPA should be counselled
about dietary and lifestyle factors that will affect their
peak bone mass, such as smoking, exercise, and calcium
intake. (Grade A)
15.
16.
17.
18.
19.
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Westhoff C,Truman C, Kalmuss D, Cushman L, Davidson A, Rulin M,
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Gupta N, O'Brien R, Jacobsen LJ, Davis A, Zuckerman A, Supran S, et al.
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Pardthaisong T. Return of fertility after use of the injectable contraceptive Depo Provera: up-dated data analysis. J Biosoc Sci 1984;16:23–34.
Fotherby K, Howard G. Return of fertility in women discontinuing
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Perrotti M, Bahamondes L, Petta C, Castro S Forearm bone density in
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Gbolade B, Ellis S, Murby B, Randall S, Kirkman R. Bone density in long
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Cromer BA, Blair JM, Mahan JD, Zibners L, Naumovski Z.. A prospective
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contraceptives. J Pediatr 1996;129:671–6.
Cundy T, Cornish J, Roberts H, Elder H, Reid IR. Spinal bone density in
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The effect of past use of the injectable contraceptive depot
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60. Tankeyoon M, Dusitsin N, Chalapati S, Koetsawang S, Saibiang S, Sas M,
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63. Gemzell-Danielsson K, van Heusden AM, Killick SR, Croxatto HB,
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68. Gu S, Sivin I, Du M, Zhang L,Ying L, Meng F, et al. Effectiveness of
Norplant implants through seven years: a large-scale study in China.
Contraception 1995;52:99–103.
69. Meckstroth K, Darney P. Implant contraception. Semin Reprod Med
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70. Croxatto HB. Progestin implants for female contraception. Contraception 2002;65:15–9.
71. Affandi B. An integrated analysis of vaginal bleeding patterns in clinical
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72. Herjan J, Bennink TC. Introduction: presentation of clinical data on
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73. Kennedy H, Murnaghan M. Implanon: when is the ideal time to insert? J
Fam Plann Reprod Health Care 2001;27:158.
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75. Sivin I, Alvarez F, Mishell DR Jr, Darney P,Wan L, Brache V, et al. Contraception with two levonorgestrel rod implants: a 5-year study in the
United States and Dominican Republic. Contraception
1998;58:275–82.
CHAPTER 6: SPECIAL CONSIDERATIONS FOR
HORMONAL CONTRACEPTION
Michèle David, MD, FRCSC
Montreal QC
INTRODUCTION
In this chapter cardiovascular disease risk and the use of hormonal contraception is discussed. The possible use or non-use
242
MARCH 2004
estradiol below 50 µg have not been associated with a further
decrease in thromboembolic risk.10,14
As the risk profile improved, small differences between
preparations of combined OCs have emerged. A variety of
progestogens are currently used in combined oral contraceptives. They are grouped as second-generation progestogens
(principally levonorgestrel) and third-generation progestogens
(desogestrel and gestodene). Norgestimate is partly converted
to levonorgestrel and has been included variably with one or the
other group.15 In 1995, the risk of VTE was reported to be
about 2-fold higher in users of combined OCs containing thirdgeneration progestogens than in users of second-generation
progestogens.16-17 This unexpected finding led to a prolonged
controversy over its validity, because of multiple potential biases including the effect of duration of use.18-19 A recent metaanalysis of studies published since 1995 has shown an overall
adjusted odds ratio of 1.7 (95% confidence interval [CI],
1.4–2.0) for VTE risk in users of third- versus second-generation oral contraceptives.20 Seven of twenty-seven potentially relevant studies were included in the final analysis. The authors
calculated an excess risk of thromboembolic events of 1.5 per
10 000 per year with use of third-generation oral contraceptives. The findings could not be explained by several potential
biases. This represents level II-2 evidence. The increase in risk
continues to be viewed with caution, both because its validity
remains questionable and because the strength of the association is small, translating into small absolute increases in risk (or
attributable risk).
Initial data suggested that the risk of VTE in users of combined oral contraceptives containing cyproterone acetate may
be increased compared to users of oral contraceptives containing second-generation progestogens.21 A major flaw in the
design of this study was the lack of adjustment for duration of
use. Other studies have not found an increase in risk.14,22 In a
recent best-evidence synthesis on 6 controlled epidemiological
studies, Spitzer found a comparable attributable risk of VTE for
conventional OCs and OCs containing cyproterone.23 Furthermore, preparations containing cyproterone are often prescribed for women with severe acne or hirsutism, with or
without polycystic ovary syndrome. These women may have
inherent differences in thromboembolic risk.24
Underlying biologic predisposition to thrombosis (thrombophilia) compounds the effect of combined OCs on the risk
of VTE.25 This effect is greater with severe thrombophilias
(deficiency of physiologic inhibitors of coagulation, such as
antithrombin, protein C or protein S; and homozygous or
combined thrombophilias) than with milder thrombophilias
(heterozygous factor V Leiden, heterozygous prothrombin gene
mutation).26 Heterozygous factor V Leiden increases the risk
of VTE 5- to 7-fold, and heterozygous prothrombin gene
mutation 2- to 3-fold. These mild thrombophilias are found
in 5 to 10% of the Caucasian population.26 Women with
of hormonal contraceptives in women with pre-existing medical conditions is also addressed.
VENOUS THROMBOEMBOLISM, MYOCARDIAL
INFARCTION, AND STROKE IN USERS OF COMBINED
AND PROGESTIN-ONLY HORMONAL CONTRACEPTION
VENOUS THROMBOEMBOLISM AND COMBINED
HORMONAL CONTRACEPTION
Venous thromboembolism (deep vein thrombosis and pulmonary embolism) has been recognized as a complication of
the use of combined oral contraceptives (OCs) since their
introduction.1 Most studies dealing with the risk of thrombosis associated with contraception are observational in design,
leading to level II evidence.1-2 Observational data are reported as point estimates, which measure the magnitude or
strength of the association.3 Point estimates are expressed in
cohort studies as the relative risk (risk of the disease in the
exposed group divided by risk of the disease in the unexposed
group) and in case-control studies as the odds ratio (odds of
exposure in the case group divided by odds of exposure in the
control group). A point estimate of 1.0 or close to 1.0 indicates that there is no association between the exposure and the
outcome. Results are significant if the confidence interval does
not overlap 1.0.3 The absolute risk is the variable of relevance
for clinical decisions. When the absolute risk is not available,
an estimate can be obtained by multiplying the baseline
incidence in the population of interest by the relative risk or
odds ratio associated with the risk factor of interest. The
attributable risk is the difference between the baseline incidence and the incidence in patients exposed to the risk factor
of interest.3
The incidence of venous thromboembolism (VTE) is
approximately 10 per 10 000 per year in adults.4 Among
healthy non-pregnant women who do not use combined OCs,
the incidence is approximately 0.3 per 10 000 per year at age
20 to 24 and increases to approximately 0.6 per 10 000 per year
at age 40 to 44.5 The risk increases exponentially thereafter.6
The incidence of VTE during pregnancy and the puerperium
is approximately 13 per 10 000 deliveries.7 The case-fatality rate
of VTE is 1 to 2%.5,8
Venous thromboembolic rates are 3- to 4-fold higher
among users of current combined OC preparations than
among non-users.9 This translates into an absolute risk of
1 to 1.5 per 10 000 women per year of use. The risk of
VTE during the first year of use has been shown consistently to be much higher than the risk during subsequent
use.10-11
The risk of VTE has been attributed to the estrogen content of combined OCs. This risk has declined as the estrogen
content of OCs has declined,12 although this effect was not significant in 1 study.13 Reductions in the content of ethinyl
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the risk of MI with use of combined OCs containing less than
50 µg ethinyl estradiol, regardless of age.33-36 Because the number of women over age 35 included in these studies is small, the
safety of combined OC use in women over 35 needs to be interpreted with caution.
Smoking is a prominent risk factor for MI; the relative
risk of MI in women who smoke is approximately 11.5,31 All
women should be counselled to stop smoking, regardless of contraceptive choice. In one study,35 no increase in risk with the
use of combined OCs was found in women smoking less than
25 cigarettes per day. A non-significant increase in risk with the
use of combined OCs was found in heavy smokers (odds ratio
[OR], 2.5; 95% CI, 0.9–7.5). Combined OC use had a compounding effect with heavy smoking, with an odds ratio of 32
(95% CI, 12–81) in heavy smokers when compared to nonsmoking non-users. Thus, age and smoking are the major risk
factors for MI in women who consider using combined OCs.
Because of the potential for combined OCs to compound the
effects of age and smoking, it is prudent to avoid their use in
women over 35 who smoke heavily.
Some studies suggest that the risk of MI is not increased
in users of combined OCs containing third-generation
progestogens, and increased about 2-fold in users of secondgeneration progestogens.37-39 It is also suggested that the casefatality rate is lower with use of third-generation combined
OCs.39 A meta-analysis of recent studies suggests that the risk
of MI is in fact lower with use of third- than with second-generation combined OCs, with an odds ratio of 0.62 (95% CI,
0.38–0.99).40 If these findings are valid, use of third-generation
combined OCs may carry less risk of death and disability than
second-generation OCs because of the higher fatality and disability rate associated with MI than that associated with venous
thromboembolic disease.41-42 It is too early, however, to recommend preferential prescribing of second- or third-generation
contraceptives based on different cardiovascular profiles. Differential prescribing according to age or underlying clinical risk
is also not recommended. Further research is necessary to determine the true comparative global risk profile of these contraceptive preparations.
Combined OC users with hypertension are at increased risk
of MI, compared to users without hypertension.31 Use of combined OCs should be avoided in women with uncontrolled
hypertension, but they may probably be used safely in women
with documented hypertension if the blood pressure is controlled by medication and followed closely. Women with hypertension who use combined OCs have a higher risk of poor
control of blood pressure with medication.43
A family history of premature atherosclerotic events may
warrant evaluation of the lipid profile before prescribing combined OCs. Hereditary thrombophilia does not influence the
risk of MI.37 Screening for thrombophilic abnormalities is therefore not indicated solely because of a family history of MI.
heterozygous factor V Leiden who do not use combined OCs
have an incidence of VTE of 5.7 per 10 000 per year.25 Women
with heterozygous factor V Leiden who use combined OCs
have a 30-fold increase in VTE risk when compared to nonusers. This translates into an absolute risk of 28.5 per 10 000
per year.25
Testing for underlying thrombophilias is generally considered indicated in women with a personal or family history of
VTE. Screening in asymptomatic women is not recommended. It has been estimated that more than 20 000 women would
need to be screened and counselled to prevent 1 episode of
venous thrombosis, and two million women would need to be
screened and counselled to prevent 1 death from pulmonary
embolism.27 The value of these strategies needs to be tested in
prospective studies.
Women with known severe thrombophilias should not use
combined OCs. Women with milder thrombophilias should
probably also avoid combined OCs, but this is less certain.
A history of VTE puts women at risk of recurrence.28
Because of this, combined OCs are generally considered
contraindicated in women with previous VTE, especially if the
thromboembolic episode was idiopathic or there is underlying
thrombophilia. Use of combined OCs can probably be considered in selected women with previous VTE if the thromboembolic episode was associated with a transient risk factor
and there is no underlying thrombophilia. Active VTE is considered an absolute contraindication to use of combined OCs.
Adequate counselling should be ensured when prescribing
combined OCs to women with an increased risk of VTE.
Cerebral vein thrombosis is also increased in users of combined OCs compared to non-users, and the risk is compounded by underlying thrombophilias.29 The baseline risk of cerebral
venous thrombosis is extremely low (estimated incidence, 0.04
per 10 000 per year).29
MYOCARDIAL INFARCTION AND COMBINED
HORMONAL CONTRACEPTION
Myocardial infarction (MI) is a rare disorder among young
women. The baseline incidence in women with no risk factors
who do not use combined OCs is estimated at 0.001 per 10 000
women per year at age 20 to 24.5 The incidence rises steeply
from age 35 upward.30 At age 40 to 44, the baseline incidence
is 0.2 per 10 000 per year.5 The case-fatality rate is about
30%,5,30 with a similar disability rate.
In users of combined OCs with an ethinyl estradiol content
of more than 50 µg, MI rates are increased approximately
3-fold.5,31 Both smoking and age over 35 compound this
risk.31-32 Because of the very low baseline incidence of MI in
women younger than 35, the compounding effect of combined
OC use becomes clinically significant chiefly in women over 35
who smoke.31
Several recent studies have found no significant increase in
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A small increase in the risk of hemorrhagic stroke with
combined OC use has been found in developing countries but
nowhere else.60
STROKE AND COMBINED HORMONAL
CONTRACEPTION
The baseline incidence of ischemic stroke in women who do
not use combined OCs is estimated at 0.06 per 10 000 women
per year at age 20 to 24.5 The incidence rises steeply from age
35 upward.5 At age 40 to 44, the incidence is 0.16 per 10 000
per year.5 The case-fatality rate of ischemic stroke is about 25%,5
with a 30% disability rate.41
A significantly increased risk of stroke is observed in users
of combined OCs with a high estrogen content.44 With current preparations, the risk has been found not to be increased
in some studies.45-46 An increase in risk up to 2-fold was found
in other studies. 47-49 A recent meta-analysis reported an
odds ratio for stroke of 1.93 (95% CI, 1.35–2.74) in users of
current preparations, after controlling for smoking and hypertension.50
The risk of stroke with use of third-generation combined
OCs appears similar to that with second-generation combined
OCs,49,51 although some data suggest a lower risk.52
Smoking is a major risk factor for stroke, with an approximate doubling of the risk overall53 as well as in women who use
combined OCs.44
Hypertension is a major risk factor for stroke.53 Combined
OC users with hypertension are at increased risk of stroke, compared with users without hypertension.54 Use of combined OCs
should be avoided in women with uncontrolled hypertension,
but they can be probably be used safely in women with documented hypertension if the blood pressure is controlled by medication and followed closely. Women with hypertension who
use combined OCs have a higher risk of poor control with medication.43
VENOUS THROMBOEMBOLISM AND PROGESTINONLY HORMONAL CONTRACEPTION
Progestins do not appear to increase the risk of VTE in contraceptive doses,61-62 but only limited data are available and 1 study
found an increased risk even when adjusting for the indication
for use.63
Progestin-only contraception is presently used as an alternative to combined OC use in women at heightened risk of
VTE. The safety of this strategy needs to be tested in prospective studies. No data exist for emergency contraception, but the
benefits far outweigh the potential risks.
MYOCARDIAL INFARCTION, STROKE, AND
PROGESTIN-ONLY HORMONAL CONTRACEPTION
The use of progestin preparations is not associated with an
increase in the risk of MI or stroke, even in therapeutic indications.47,63 Women at heightened risk of MI or stroke, including
women with atypical migraine, can use progestin-only contraception as well as progestin-only emergency contraception.
HORMONAL CONTRACEPTION IN WOMEN WITH PREEXISTING CONDITIONS
It is important to balance the risks of pregnancy with the risks
of oral contraceptives in women with pre-existing conditions.
HYPERLIPIDEMIA
The presence of hypertriglyceridemia increases the risk of pancreatitis and is a relative contraindication to the use of combined
OCs.64
MIGRAINE AND COMBINED HORMONAL CONTRACEPTION
Women taking combined OCs may notice an increase or a
decrease in the severity of their headaches. Tension headaches
are not related to combined OC use. Migraine headache is
associated with an approximately 3-fold increase in risk of
ischemic stroke.55,56 The risk of stroke is considered higher in
women who have migraine with aura (relative risk approximately 6 compared with women without migraine), 57
although not all studies report a difference.56 The risk of stroke
is further increased by the presence of hypertension, smoking,
and the use of combined OCs.56,57 Migraine is not considered
a contraindication to the use of combined OCs in the absence
of aura or other risk factors.58 Combined OC use is generally considered contraindicated in patients with migraine aura,58
although visual scintillations lasting less than 1 hour are
considered acceptable by some authors.59 New-onset headache
or worsening headache require discontinuation of combined
OCs and re-evaluation of the patient. Headache that occurs
repeatedly in the pill-free week may be prevented by continuous use.
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DIABETES MELLITUS
Early combined OC formulations impaired glucose metabolism by increasing peripheral insulin resistance.65 Currently
available products have no appreciable effect on carbohydrate
metabolism.65 There is no evidence that use of combined OCs
worsens the course of type 1 or 2 diabetes mellitus in the
absence of vascular disease. Effective prevention of pregnancy
outweighs the small risk of complicating vascular disease in diabetic women who are otherwise healthy, and whose diabetes is
well controlled.66-67
LIVER AND GALLBLADDER DISEASE
Combined OC use increases the secretion of cholic acid in
bile.68 Women using combined OCs have a small increase in
the risk of symptomatic gallstones.69 Combined OCs should
not be used in women with active liver disease, or in women
with known benign or malignant liver tumours.70
245
MARCH 2004
SUMMARY STATEMENTS
INFLAMMATORY BOWEL DISEASE
There may be a modest association between the use of combined OCs and the development of inflammatory bowel disease.71 Combined OCs have been reported to increase the risk
of relapse of inflammatory bowel disease in some studies, but
not all.72-73 Combined OCs may be absorbed inadequately in
the presence of chronic inflammation or active diarrhea.74
1. The risk of myocardial infarction and stroke is increased significantly with smoking and may be slightly increased with
the use of combined OCs. Because cardiovascular disease
increases rapidly in women aged over 35, and because risk
factors have a compounding effect, the use of combined OCs
in smokers significantly increases the cardiovascular risk over
the age of 35. (Level II-2)
2. Whether women should discontinue low-dose combined
OC use before elective surgery is controversial. The decision
must take into account the risk of unwanted pregnancy and
the risk of post-operative thromboembolic events. (Level III)
3. The association between antibiotic use and contraceptive failure is based on isolated case reports only. Pharmacologic and
cohort studies do not support an effect of antibiotics on combined OC-induced ovulation suppression or contraceptive
failure. (Level II-2)
SYSTEMIC LUPUS ERYTHEMATOSUS
Combined OCs are generally not prescribed to women with
systemic lupus erythematosus because estrogen can exacerbate
the disease. However, their use may be considered in selected
cases, in the absence of active nephritis or antiphospholipid antibodies.75
SICKLE CELL DISEASE
Women with sickle cell disease are at increased risk of stroke.76
However, the risk of pregnancy is high in these women, and
effective prevention of pregnancy is essential. Despite a paucity of data, the general consensus is that combined OCs can be
used. In one study, women randomized to use of depotmedroxyprogesterone acetate (DMPA) or combined OC,
reported a more marked improvement in painful crises with the
use of DMPA (70% reduction) than with OC (54.5% reduction ). Control women had a 50% reduction of crises.77
Yoong found some form of cyclical crises in 58% of women
and concluded that DMPA should be considered in severe cases.78
RECOMMENDATIONS
1. All women who smoke should be counselled to stop.
Women over 35 who smoke should be advised not to use
combined OCs. (Grade A)
2. Women using combined OCs who are undergoing major
surgery or surgery that will be followed by prolonged
periods of immobility should receive peri-operative antithrombotic prophylaxis. (Grade A) Consideration may be
given to discontinuing low-dose combined OCs 4 weeks
prior to elective surgery. A reliable contraceptive method
(e.g., progestin-only contraception) should be substituted when combined OCs are withdrawn. (Grade C)
EPILEPSY
Combined OCs can be used safely in women with epilepsy.79
Some drugs reduce the efficacy of combined OCs.80 In this case,
the use of combined OCs containing more than 35 µg of
ethinyl estradiol may be warranted.81
It is recommended that injections of DMPA be given every
10 weeks rather than every 12 weeks in women who are receiving antiepileptic drugs that induce hepatic microsomial
enzymes.81
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oral contraceptives: reviewing the evidence and balancing the risks. Hum
Reprod Update 1999;5:721–35.
Vasilakis C, Jick H, del Mar Melero-Montes M. Risk of idiopathic venous
thromboembolism in users of progestagens alone. Lancet
1999;354:1610–1.
Heinemann LAJ, Assmann A, DoMinh T, Garbe E, and the Transnational
Research Group on Oral Contraceptives and the Health of Young
Women. Oral progestogen-only contraceptives and cardiovascular risk:
results from the Transnational Study on Oral Contraceptives and the
Health of Young Women. Eur J Contracept Reprod Health Care
1999;4:67–73.
Poulter ND, Chang CL, Farley TMM, Meirik O. Risk of cardiovascular diseases associated with oral progestagen preparations with therapeutic
indications. Lancet 1999;354:1610.
Parker WA. Estrogen-induced pancreatitis. Clin Pharm 1983;2(1):75-9.
Skouby SO, Molsted-Pedersen L, Kuhl C, Bennet P. Oral contraceptives
in diabetic women: metabolic effects of four compounds with different
estrogen/progestogen profiles. Fertil Steril 1986;46:858–64.
Kjos SL. Contraception in diabetic women. Obstet Gynecol Clin North
Am 1996;23:243–58.
Garg SK, Chase HP, Marshall G, Hoops SL, Holmes DL, Jackson WE. Oral
contraceptives and renal and retinal complications in young women
with insulin-dependent diabetes mellitus. JAMA 1994;271(14):10991102.
Bennion LJ, Ginsberg RL, Garnick MB, Bennett PH. Effects of oral contraceptives on the gallbladder bile of normal women. N Engl J Med
1976;294:189–92.
Grodstein F, Colditz GA, Hunter DJ, Manson JE,Willett WC, Stampfer
MJ. A prospective study of symptomatic gallstones in women: relation
with oral contraceptives and other risk factors. Obstet Gynecol
1994;84:207–14.
Connolly TJ, Zuckerman AL. Contraception in the patient with liver disease. Semin Perinatol 1998;22:178–82.
Godet PG, May GR, Sutherland LR. Meta-analysis of the role of oral contraceptive agents in inflammatory bowel disease. Gut 1995;37:668–73.
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CHAPTER 7: INTRAUTERINE DEVICES
Amanda Black, MD, FRCSC
Ottawa ON
INTRODUCTION
Worldwide, over 100 million women have used the intrauterine
contraceptive device (IUD). However, in North America less
than 1% of women use this highly effective method of contraception. In Canada, 2 copper IUDs (Nova-T and Flexi-T 300)
and a levonorgestrel-releasing device (Mirena) are currently
available.
Mirena is also referred to as a levonorgestrel-releasing
intrauterine system (LNG-IUS).
EFFICACY
Intrauterine devices are highly effective methods of reversible
contraception. In a large trial, the failure rate of a copper IUD
(Nova-T) was 1.26 per 100 women-years (WY) and the rate
of ectopic pregnancy was 0.25 per 100 WY. The failure rate
of the levonorgestrel-releasing intrauterine system was 0.09
per 100 WY and the ectopic pregnancy rate was 0.02 per 100
WY.1
Although the product monograph for the Nova-T copper
IUD suggests that it be replaced every 30 months, clinical trials
have shown that it is effective for 5 years.1,2 The Flexi-T 300 copper IUD and the LNG-IUS should be replaced every 5 years.
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MECHANISM OF ACTION
CONTRAINDICATIONS
Intrauterine devices have multiple mechanisms of action. The
chief mechanism of action of all IUDs appears to be the prevention of fertilization.3 If fertilization does occur, IUDs also
appear to have post-fertilization effects, including the potential
inhibition of implantation.4
The copper-bearing IUDs consist of a vertical stem with a
silver-cored copper wire wound around it. The presence of a
foreign body and of copper in the endometrial cavity causes
biochemical and morphological changes in the endometrium.
These changes adversely affect sperm transport so that fertilization rarely occurs.5-7 The copper ions also have a direct effect
on sperm motility, reducing the ability of sperm to penetrate
cervical mucus. Ovulation is not affected in users of the copper IUD.
The levonorgestrel-releasing intrauterine system consists of
a small polyethylene T-shaped frame with a cylindrical reservoir
containing levonorgestrel on its vertical arm. This cylinder slowly releases hormone through a rate-limiting membrane. The
LNG-IUS produces a weak foreign body reaction and endometrial changes that include endometrial decidualization and glandular atrophy. 8 Endometrial estrogen and progesterone
receptors are suppressed.9 Cervical mucus may become thickened, creating a barrier to sperm penetration.10 Ovulation may
be inhibited in some women.11,12
The World Health Organization (WHO) has developed a
list of absolute and relative contraindications to use of an
IUD.13
ABSOLUTE CONTRAINDICATIONS
• pregnancy
• current, recurrent, or recent (within past 3 months)
pelvic inflammatory disease (PID) or sexually transmitted infection (STI)
• puerperal sepsis
• immediate post-septic abortion
• severely distorted uterine cavity
• unexplained vaginal bleeding
• cervical or endometrial cancer
• malignant trophoblastic disease
• copper allergy (for copper IUDs)
• breast cancer (for LNG-IUS)
RELATIVE CONTRAINDICATIONS
• risk factor for STIs or human immunodeficiency virus
(HIV)
• impaired response to infection
- in HIV-positive women
- in women undergoing corticosteroid therapy
• from 48 hours to 4 weeks postpartum
• ovarian cancer
• benign gestational trophoblastic disease
INDICATIONS
In the absence of contraindications, the IUD may be considered for any woman seeking a reliable, reversible, coitally independent method of contraception. It is particularly suited for
women seeking long-term birth control or a method requiring
less compliance. Women who have contraindications or sensitivities to estrogen, or women who are breastfeeding, may be
good candidates for use of an IUD.
The copper IUD, in appropriately selected patients, may
be used for postcoital contraception in women presenting up
to 7 days after an act of unprotected intercourse.
The LNG-IUS has been shown to decrease menstrual flow
and cramping, and therefore has been used in women with
menorrhagia and dysmenorrhea.1 It should not be used for postcoital contraception.
NON-CONTRACEPTIVE BENEFITS
Intrauterine devices are used primarily for contraception, but
they also provide a number of non-contraceptive health
benefits.
Case-control studies provide some evidence that use of nonmedicated or copper IUDs reduces the risk of endometrial cancer.14 This protective effect is not related to the duration or
timing of use, and its mechanism is not well understood.
Menorrhagia responds favourably to use of the LNG-IUS,
with reported reductions in menstrual blood loss of 74 to
97%15-19 and favourable effects on hemoglobin levels.20 In 2
studies of women scheduled to undergo hysterectomy for menorrhagia, 64 to 80% of women randomized preoperatively to
LNG-IUS insertion subsequently cancelled their hysterectomy,
compared with 9 to 14% of women randomized to receive
other medical treatments.21,22 Dysmenorrhea may also improve
in LNG-IUS users.16,23
A randomized controlled study found that use of the LNGIUS protects against endometrial hyperplasia in women on
tamoxifen.24 Small reports support a beneficial effect in the
treatment of fibroid-related menorrhagia.25,26
Comparison of IUD and LNG-IUS Devices
Type of Device
Copper IUD (Nova-T)
LNG-IUS
Failure rate
per 100
womanyears1
(Pearl Index)
Ectopic rate
per 100
womanyears1
Duration of
action1
1.26
0.09
0.25
0.02
5 years
5 years
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SIDE EFFECTS
RISKS
1. BLEEDING
1. UTERINE PERFORATION
Irregular menstrual bleeding or an increase in the amount of
bleeding are the most common side effects of IUDs in the first
months after insertion. Menstrual blood loss in users of copper IUDs increases by up to 65% over non-users.27,28 Use of
non-steroidal anti-inflammatory agents (NSAIDs) or tranexamic acid may help to decrease the amount of menstrual
blood loss. The average number of days of spotting or bleeding appears to decrease over time. Users of copper IUDs have
an average of 13 days of bleeding or spotting in the first
month after insertion, decreasing to an average of 6 days at 12
months after insertion.1 The cumulative termination rates for
bleeding problems after 5 years of use are up to 20% for
copper IUDs.1
By contrast, users of the LNG-IUS experience a reduction
in menstrual blood loss of between 74 and 97%.15-18 Women
using the LNG-IUS have an average of 16 days of bleeding
or spotting at 1 month after insertion, and this decreases to an
average of 4 days by 12 months after insertion. The cumulative termination rates for bleeding problems after 5 years of use
are up to 14% for the LNG-IUS.20 Between 16 and 35% of
LNG-IUS users will become amenorrheic after one year of
use.1,20,29 Since information received in advance will improve
user satisfaction, patients should be carefully counselled regarding potential menstrual changes prior to IUD insertion.30
Uterine perforation is a rare complication of IUD insertion,
occurring at a rate of 0.6 to 1.6 per 1000 insertions.33,34 All uterine perforations, either partial or complete, occur or are initiated
at the time of IUD insertion. Risk factors for perforation include
postpartum insertion, an inexperienced operator, and a uterus
that is immobile, extremely anteverted or extremely retroverted.
2. INFECTION
Methodological flaws in early observational research exaggerated the risk of PID associated with IUD use. Evidence from large
cohort studies,35 case-control studies,36 and randomized controlled trials37 indicates that any risk of genital tract infection
after the first month of IUD use is small. There appears to be
an inverse relation between the risk of infection and the time
since IUD insertion. The Women’s Health Study data showed
a relative risk of PID of 3.8 in the first month after insertion,
reaching baseline risk after 4 months.36 Investigations by the
World Health Organization found the risk to be highest in the
first 20 days following insertion.37 Although insertion of an
IUD contaminates the endometrial cavity with bacteria, the
cavity becomes sterile soon afterwards. Exposure to STIs, and
not the use of the IUD itself, is responsible for PID occurring
after the first month of use.
It remains unclear whether the risk of PID is reduced in
users of the LNG-IUS compared to users of the copper
IUDs.1,38,39 IUD users should continue to use condoms for
protection against STIs.
2. PAIN OR DYSMENORRHEA
Up to 6% of copper IUD and LNG-IUS users will have
discontinued use at 5 years because of pain.1 Pain may be
a physiological response to the presence of the device, but the
possibility of infection, malposition of the device (including perforation), and pregnancy should be excluded. The
LNG-IUS has been associated with a decrease in menstrual
pain.16,23
3. EXPULSION
Expulsion of the IUD is most common in the first year of use
(2–10% of users). The 5-year cumulative expulsion rate for the
copper IUD is 6.7% and for the LNG-IUS is 5.8%.1 Risk factors for expulsion include insertion immediately postpartum,
nulliparity, and previous IUD expulsion.40 A woman who has
expelled one IUD has a 30% chance of expelling a subsequent
device.41
3. HORMONAL
The LNG-IUS appears to exert some systemic hormonal effects,
even though the daily dose of levonorgestrel is extremely low.
Hormonal side effects include depression, acne, headache, and
breast tenderness.1 Most studies report a low incidence of
such adverse effects, which appear to be maximal at 3 months
after insertion and then decrease. Although weight gain has been
reported as a side effect of LNG-IUS use, a large trial reported
no significant difference in weight gain over 5 years in LNGIUS users and copper IUD users.1
4. FAILURE
If a woman becomes pregnant with an IUD in situ, the possibility of ectopic pregnancy must be excluded.
The risk of spontaneous abortion is increased in women
who continue a pregnancy with an IUD in place. The UK Family Planning Research Network study found that 75% of
pregnancies aborted if a copper IUD was left in situ, but that
early removal virtually eliminated the risk of septic abortion.
If the IUD was removed, 89% of women had a live birth, compared to 25% of women who left the IUD in place.42 Although
the risk of spontaneous abortion appears to be normalized after
IUD removal, the risk of preterm delivery remains higher.43
4. FUNCTIONAL OVARIAN CYSTS
Functional ovarian cysts have been reported in up to 30% of
LNG-IUS users.31 Since these cysts usually resolve spontaneously,32 they should be managed expectantly.31
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These women are at higher risk of expulsion and uterine perforation.50 In most circumstances, it is best to wait to insert the IUD
until the uterus is completely involuted, usually at 4 to 6 weeks
postpartum. Women should wait until 6 weeks post-partum to
have the LNG-IUS inserted. An IUD can be safely inserted
immediately after a first trimester pregnancy termination.
The cost-effectiveness of screening for gonorrhea and
chlamydia infection prior to IUD insertion is unclear. The
cervix should be carefully inspected prior to IUD insertion, and,
if there is any evidence of mucopurulent discharge or pelvic tenderness, cervical swabs should be performed and IUD insertion
delayed until the results are known.
MYTHS AND MISCONCEPTIONS
1. Nulliparous women cannot use IUDs.
Fact: Nulliparity is not a contraindication to IUD use.44 In
carefully selected nulliparous women, IUDs may be successfully used.
2. IUDs increase the risk of ectopic pregnancy.
Fact: IUDs do not increase the risk of ectopic pregnancy.
Because IUDs work primarily by preventing fertilization,
IUD users have a lower risk of ectopic pregnancy than
women who are not using any form of birth control
(0.02–0.25/100 WY versus 0.12–0.5/100 WY). However,
in women who conceive with an IUD in place, the diagnosis of ectopic pregnancy should be excluded.
3. IUDs increase the risk of infertility.
Fact: IUDs do not increase the risk of infertility. Women who
discontinue use of an IUD in order to conceive are able to
conceive at the same rate as women who have never used an
IUD. Copper IUD use is not associated with an increase in
tubal factor infertility in nulliparous women.45
4. IUDs increase the long-term risk of PID.
Fact: The incidence of PID among IUD users is less than 2
episodes per 1000 years of use,37,46 similar to that of the general population. The increase in risk of PID associated with
IUD use appears to be related only to the insertion process.
After the first month of use, the risk of infection is not significantly higher than in women without IUDs.
5. IUDs are not effective contraceptives.
Fact: IUDs are a highly effective method of birth control. In
fact, in long-term users of IUDs, the failure rate approaches
that of tubal ligation.47
The LNG-IUS appears to be as effective as tubal ligation.48
ANTIBIOTIC PROPHYLAXIS
A Cochrane Collaboration review concluded that neither doxycycline nor azithromycin before IUD insertion conferred
benefit.51
According to the American Health Association’s 1997
guidelines for prevention of bacterial endocarditis (SBE), antibiotic prophylaxis is not necessary prior to IUD insertion if there
is no obvious infection.52 However, in the presence of infection,
removal of an IUD requires SBE antibiotic prophylaxis.
FOLLOW UP
A follow-up visit should be scheduled post-insertion. This allows
for the exclusion of infection, an assessment of bleeding patterns, an assessment of patient and partner satisfaction, and an
opportunity to reinforce the issue of condom use for protection
against STIs and HIV. After this visit, an IUD user should continue annual well-woman care as for any sexually active woman.
An IUD user should be instructed to contact her healthcare provider if any of the following occur:
• she cannot feel the IUD’s threads
• she or her partner can feel the lower end of the IUD
• she thinks she is pregnant
• she experiences persistent abdominal pain, fever, or
unusual vaginal discharge
• she or her partner feel pain or discomfort during intercourse
• she experiences a sudden change in her menstrual periods
• she wishes to have the device removed or wishes to conceive
INITIATION
Prior to insertion, informed consent should be obtained and
the patient should be aware of the risks, benefits, and alternative
methods of contraception. Patients should be counselled regarding the potential side effects associated with the IUD of choice,
particularly alterations in the menstrual cycle. Patients should also
be reminded that the IUD does not protect against STIs or HIV.
The IUD can be inserted at any time during the menstrual
cycle once pregnancy or the possibility of pregnancy can be
excluded. Although the advantages of inserting the IUD during or shortly after menses include ruling out pregnancy and
the masking of insertion-related bleeding, there is no evidence
to support the common practice of inserting the IUD only during menses. In fact, infection and expulsion rates may be higher when inserted during menses.46,49 The IUD can be removed
and replaced at the same time on any day of the menstrual cycle.
Postpartum women may be candidates for immediate IUD
insertion (within 10–15 minutes after delivery of the placenta).
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TROUBLESHOOTING
1. LOST STRINGS
If an IUD user is unable to palpate the IUD strings, a speculum exam should be performed. If the strings are not seen in
the cervical os, the device may have been expelled, may have
perforated the uterine wall, or the strings may have been drawn
up into the cervical canal. Pregnancy should be excluded. Once
pregnancy is excluded, the cervical canal should be explored
(with a cotton swab, cytobrush, forceps, or similar instrument)
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vres are needed, a paracervical block may be considered. A uterine sound can be passed into the endometrial cavity to localize
the IUD. Cervical dilation may be required. Once localized, the
IUD can be subsequently grasped with a small grasping instrument directed towards it. If removal is not easily performed,
direct visualization of the IUD with ultrasound or hysteroscopy
may be required. Occasionally general anesthetic may be needed to carry out IUD removal.
to see if the strings can be found. If the strings cannot be found,
ultrasound is the preferred method to identify the location of
the IUD. If the device is seen within the uterus, it can be left in
situ. If the device is not identified within the uterus or the pelvis,
a plain x-ray of the abdomen should be performed to determine
whether the device has perforated the uterine wall. Both the
LNG-IUS and the copper IUD are radio-opaque.
2. PREGNANCY WITH AN IUD IN PLACE
Once the diagnosis of an ectopic pregnancy has been excluded, the woman should be asked about her wishes for the pregnancy. If she wishes to terminate the pregnancy, the device
should be left in place until the procedure. If she wishes to continue with the pregnancy, the IUD should be removed if possible. If the strings are visible, gentle traction is applied to
remove the device. If the strings are not visible, gentle exploration of the cervical canal is performed. If no strings are found,
the possibility of perforation must be considered. This is best
excluded by pelvic ultrasound. Despite reports of successful
hysteroscopic IUD removal during the first trimester,53,54 if the
device remains in the uterus then usually no attempt is made
to remove it. Note should be made of recovery of the IUD at
the time of delivery.
6. STI IDENTIFIED WITH IUD IN PLACE
Appropriate antibiotic therapy should be initiated for an IUD
user (and her sexual contacts) found to have chlamydial or
gonoccocal cervicitis. If there is a suggestion of PID, the device
should be removed after pre-treating the woman with antibiotics. She should be counselled regarding the use of barrier contraceptive methods for STI prevention.
7. ACTINOMYCOSIS ON PAP SMEAR
Actinomycosis is considered a commensal vaginal organism55
but may be associated with frank infection. Up to 20% of cervical smears in long-term copper IUD users show evidence of
Actinomycosis, although this finding is only noted in up to
3% of LNG-IUS users.56 However, when cultures are performed, only 40% of women with Actinomyces-like organisms
found on Pap smears are shown to be colonized. Removal of the
device in women with Actinomycosis on their Pap smear may
not be necessary.55 In the asymptomatic woman, it is reasonable
to leave the IUD in place, follow her with annual Pap smears
and pelvic examinations, and warn her of potential symptoms
of PID. If the decision is made to treat, antibiotic therapy with
penicillin G, tetracycline, or doxycycline may be given. If the
woman is symptomatic, the IUD should be removed after antibiotic preloading. If the infection is severe, she should be hospitalized, treated for PID, and investigated for possible abscess.
3. AMENORRHEA OR DELAYED MENSES
Pregnancy must be excluded. Once pregnancy has been excluded, investigation should be as for a woman without an IUD.
Up to 35% of LNG-IUS users may experience amenorrhea.1,20,29 If proper positioning of the LNG-IUS is confirmed,
it is unnecessary to perform repeated pregnancy tests. If the
IUD user is post-menopausal, the device should be removed.
4. PAIN AND ABNORMAL BLEEDING
Increased menstrual bleeding with or without an increase in
menstrual cramping may occur in IUD users. In the event of
partial expulsion or perforation, the device should be removed
and consideration given to inserting another IUD. In the first
few months after insertion, pain and spotting can also occur
between menses. Once partial expulsion, perforation, pregnancy, and infection are ruled out, treatment with NSAIDs may be
helpful in treating these symptoms. The number of days of
bleeding or spotting usually decreases over time.1 If pain or bleeding persists or worsens, removing the IUD must be considered.
IUD users should be informed about potential changes in
bleeding patterns, as well as signs and symptoms of infection
prior to IUD insertion.
SUMMARY STATEMENTS
1. In women who are at low risk of acquiring STIs, the use of
an intrauterine device may be an excellent contraceptive
option. Efficacy rates for the levonorgestrel-releasing
intrauterine system approach those of surgical sterilization;
it is therefore an excellent alternative to surgical sterilization
for women who seek long-term contraception. (Level II-2)
2. The copper IUDs (Nova-T and Flexi-T 300) and the LNGIUS (Mirena) provide effective contraception for 5 years.
(Level I)
3. The risk of genital tract infection after the first month of IUD
use is small. There appears to be an inverse relation between
risk of infection and time since IUD insertion. Although the
relative risk of pelvic inflammatory disease (PID) in the first
month after insertion is increased slightly, the absolute risk
is still low. Exposure to sexually transmitted infections, and
5. DIFFICULTY REMOVING THE IUD
Grasping the string with a ring forceps and exerting gentle traction can usually accomplish removal of an IUD. If the strings
cannot be seen, manoeuvres such as those described above can
be used to assist in localizing the strings. If further manoeuJOGC
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MARCH 2004
not the use of the IUD itself, is responsible for PID occurring after the first month of use. (Level II-2)
4. Both types of IUDs provide excellent contraceptive efficacy
(Level 1). In addition, the copper IUD may decrease the risk
of endometrial cancer (Level II-2); the levonorgestrelreleasing IUS may provide an acceptable alternative to hysterectomy, by decreasing menorrhagia and increasing hemoglobin concentrations. (Level I)
15.
16.
17.
18.
RECOMMENDATIONS
1. Health-care professionals providing family planning services should be familiar with the use of the intrauterine
device (IUD). (Grade A)
2. Appropriately trained personnel in adequately equipped
facilities should be available in order to ensure that
women have access to the IUD if they desire this method
of contraception. (Grade A)
19.
20.
21.
REFERENCES
22.
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2. No author.The TCu380A,TCu220C, multiload 250 and Nova T IUDS at
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Milsom I, Andersson K, Jonasson K, Lindstedt G, Rybo G.The influence
of the Gyne-T 380S IUD on menstrual blood loss and iron status. Contraception 1995;52:175–9.
Larsson G, Milsom I, Jonasson K, Lindstedt G, Rybo G.The long-term
effects of copper surface area on menstrual blood loss and iron status
in women fitted with an IUD. Contraception 1993;48:471–80.
Luukkainen T, Allonen H, Haukkamaa M, Holma P, Pyorala T,Terho J, et al.
Effective contraception with levonorgestrel-releasing intrauterine
device: 12 month report of a European multinational study. Contraception 1987;36:169–79.
Backman T, Huhtala S, Luoto R,Tuominen J, Rauramo I, Koskenvuo M.
Advance information improves user satisfaction with the levonorgestrel
intrauterine system. Obstet Gynecol 2002;99:608–13.
Jarvela I,Tekay A, Jouppila P.The effect of a levonorgestrel-releasing
intrauterine system on uterine artery blood flow, hormone concentrations and ovarian cyst formation in fertile women. Hum Reprod
1998;13:3379–83.
Pakarinen PI, Suvisaari J, Luukkainen T, Lahteenmaki P. Intracervical and
fundal administration of levonorgestrel for contraception: endometrial
thickness, patterns of bleeding, and persisting ovarian follicles.
Fertil Steril 1997;68:59–64.
The World Health Organization. Mechanism of action, safety, and efficacy of intrauterine devices.Technical Report Series, 753.. Geneva:WHO;
1987.
Harrison-Woolrych M, Ashton J, Coulter D. Uterine perforation on
intrauterine device insertion: is the incidence higher than previously
reported? Contraception 2003;67:53–6.
Tietze C. Evaluation of intrauterine devices: ninth progress report of the
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Cooperative Statistical Program. Stud Fam Plann 1970;55:1–40.
36. Lee NC, Rubin GL, Ory HW, Burkman RT.Type of intrauterine device
and the risk of pelvic inflammatory disease. Obstet Gynecol
1983;62:1–6.
37. Farley TM, Rosenberg MJ, Rowe PJ, Chen JH, Meirik O. Intrauterine
devices and pelvic inflammatory disease: an international perspective.
Lancet 1992;339:785–8.
38. Toivonen J, Luukkainen T, Allonen H. Protective effect of intrauterine
release of levonorgestrel on pelvic infections: three years' comparative
experience of levonorgestrel and copper-releasing intrauterine devices.
Obstet Gynecol 1991;77:261–4.
39. Sivin I, Stern J, Coutinho E, Mattos CE, el Mahgoub S, Diaz S, et al. Prolonged intrauterine contraception: a seven-year randomized study of
the levonorgestrel 20 mcg/day (LNg 20) and the copper T380 Ag IUD.
Contraception 1991;44:473–80.
40. Bahamondes L, Diaz J, Marchi NM, Petta CA, Cristofoletti ML, Gomez
G. Performance of copper intrauterine devices when inserted after an
expulsion. Hum Reprod 1995;10:2917–8.
41. Zhang J, Feldblum PJ, Chi IC, Farr MG. Risk factors for copper-T IUD
expulsion: an epidemiological analysis. Contraception 1992;46:427–33.
42. United Kingdom Family Planning Research Network. Pregnancy
outcome associated with the use of IUDs. Br J Fam Plann 1989;15:7–10.
43. Chaim W, Mazor M. Pregnancy with an intrauterine device in situ and
preterm delivery. Arch Gynecol Obstet 1992;252:21–4.
44. Hubacher D, Lara-Ricalde R,Taylor DJ, Guerra-Infante F, GuzmanRodriguez R. Use of copper intrauterine devices and the risk of tubal
infertility among nulligravid women. N Engl J Med. 2001;345 (8): 561-7.
45. Grimes DA. Intrauterine devices and infertility: sifting through the
evidence. Lancet. 2001 Jul 7; 358(9275): 6-7.
46. Jovanovic R, Barone CM,Van Natta FC, Congema E. Preventing infection
related to insertion of an intrauterine device. J Reprod Med
1988;33:347–52.
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47. Peterson HB, Xia Z, Hughes JM,Wilcox LS,Tylor LR,Trussell J.The risk
of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol. 1996 Apr; 174(4):
1161-8.
48. Sturridge F, Guillebaud J. A Risk-Benefit Assessment of the Levonorgestrel-Releasing Intrauterine System. Drug Safety 1996;15(6):430-440.
49. White MK, Ory HW, Rooks JB, Rochat RW. Intrauterine device termination rates and the menstrual cycle day of insertion. Obstet Gynecol
1980;55:220–4.
50. Grimes D, Schulz K, van Vliet H, Stanwood N. Immediate post-partum
insertion of intrauterine devices (Cochrane Methodology Review). In:
The Cochrane Library 2003;(4).
51. Grimes DA, Schulz KF. Antibiotic prophylaxis for intrauterine
contraceptive device insertion (Cochrane Methodology Review). In:The
Cochrane Library 2001;(2).
52. Dajani AS,Taubert KA,Wilson W, Bolger AF, Bayer A, Ferrieri P, et al. Prevention of bacterial endocarditis: recommendations by the American
Heart Association. JAMA 1997;277:1794–1801.
53. Assaf A, Gohar M, Saad S, el-Nashar A, Abdel Aziz A. Removal of
intrauterine devices with missing tails during early pregnancy. Contraception 1992;45:541–6.
54. Hucke J, Campo RL, Kozlowski P, De Bruyne F. Experience with
hysteroscopy or ultrasound-controlled removal of an intrauterine spiral
with no visible thread in early pregnancy. Geburtshilfe Frauenheilkd
1991;51(1):31–3.
55. Lippes J. Pelvic actinomycosis: a review and preliminary look at
prevalence. Am J Obstet Gynecol 1999;180(2 Pt 1):265–9.
56. Merki-Feld GS, Lebeda E, Hogg B, Keller PJ.The incidence of
actinomyces-like organisms in Papanicolaou-stained smears of copperand levonorgestrel-releasing intrauterine devices. Contraception
2000;61:365–8.
254
MARCH 2004
No. 143 – Part 3 of 3, April 2004
CANADIAN CONTRACEPTION CONSENSUS
PRINCIPAL AUTHORS
CONTRIBUTING AUTHORS
Amanda Black, MD, FRCSC, Ottawa ON
Diane Francoeur, MD, FRCSC, Montréal QC
Timothy Rowe, MB, FRCSC,Vancouver BC
John Collins, MD, FRCSC, Mahone Bay NS
Dianne Miller, MD, FRCSC,Vancouver BC
PROJECT COORDINATOR
CONTRACEPTION GUIDELINES COMMITTEE
Elke Henneberg, Communications Message & More Inc., Montréal QC
Thomas Brown, PharmD,Toronto ON
Michèle David, MD, FRCPC, Montréal QC
Sheila Dunn, MD, CCFP(EM),Toronto ON
William A. Fisher, PhD, London ON
Nathalie Fleming, MD, FRCSC, Ottawa ON
Claude A. Fortin, MD, FRCSC, Montréal QC
Edith Guilbert, MD, MSc, Quebec City QC
Louise Hanvey, BN, MHA, Chelsea QC
André Lalonde, MD, FRCSC, Ottawa ON
Ruth Miller, MEd,Toronto ON
Margaret Morris, MD, FRSCS,Winnipeg MB
Teresa O’Grady, MD, FRCSC, St. John’s NL
Helen Pymar, MD, MPH, FRCSC,Toronto ON
Thirza Smith, MD, FRCSC, Saskatoon SK
Abstract
Objective: To provide guidelines for health-care providers on
the use of contraceptive methods to prevent pregnancy and
sexually transmitted diseases.
Outcomes: Overall efficacy of cited contraceptive methods,
assessing reduction in pregnancy rate, risk of infection, safety,
ease of use, and side effects; the effect of cited contraceptive
methods on sexual health and general well-being; and the cost
and availability of cited contraceptive methods in Canada.
Evidence: Medline and the Cochrane Database were searched
for articles in English on subjects related to contraception, sexuality, and sexual health from January 1988 to March 2003, in
order to update the Report of the Consensus Committee on
Contraception published in May–July 1998. Relevant Canadian
Government publications and position papers from appropriate
health and family planning organizations were also reviewed.
Values: The quality of the evidence is rated using the criteria
described in the Report of the Canadian Task Force on the
Periodic Health Examination. Recommendations for practice
are ranked according to the method described in this Report.
Key Words
Contraception, statistics, Canada, sexuality, sexual health, hormonal
contraception, emergency contraception, barrier methods of
contraception, contraceptive sponge, female condoms, contraceptive
diaphragm, cervical cap, spermicide, fertility awareness, abstinence,
tubal ligation, vasectomy, sterilization, intrauterine devices
Recommendations
Chapter 8: Barrier Methods
1. Health-care providers should promote the consistent and correct use of latex condoms to protect against pregnancy,
human immunodeficiency virus (HIV) infection, and other STIs.
(Grade A) Men and women should be provided with information on the male and female condom.
2. Women who use barrier methods of contraception should be
provided with emergency contraception and relevant counselling. (Grade B)
3. Health-care providers should educate women and men about
the correct use of barrier methods. They should emphasize
the need for dual protection against pregnancy and infections.
(Grade B)
4. The use of spermicide-coated condoms should no longer be
promoted. Nevertheless, the use of a nonoxynol-9 lubricated
condom is preferable to the use of no condom at all.
(Grade C)
5. Health-care providers should be encouraged to be familiar
with the technique of fitting a diaphragm. Diaphragms and cervical caps should continue to be available in Canada. (Grade C)
6. Nonoxynol-9 should not be used to reduce the risk of STIs
and HIV infection. Condoms should always be used to reduce
the risk of infections. (Grade A)
7. Since frequent use of nonoxynol-9 products may cause epithelial damage and increase the risk of HIV infection, women
who have multiple daily acts of intercourse should be advised
to avoid using nonoxynol-9 products. (Grade A)
Chapter 9: Natural Family Planning Methods
1. Health-care providers should respect the choice of a natural
family planning method and be able to provide resources to
support the correct use of this method. (Grade C)
2. The use of coitus interruptus (“withdrawal”) should be recognized as a risk-reduction strategy. When couples use coitus
interruptus or other natural family planning methods, healthcare providers should provide information about emergency
contraception. (Grade C)
3. Health-care providers should acknowledge and legitimize
abstinence as a valid contraceptive choice. (Grade B)
4. Comprehensive sex education should be available to all
Canadians. Education programs should provide information on
abstinence as well as on contraception and STI prevention.
(Grade B)
5. Health-care providers should be able to counsel postpartum
women about the contraceptive efficacy and correct use of
the lactational amenorrhea method. (Grade A)
Chapter 10: Sterilization
1. Couples choosing a sterilization procedure should be informed that vasectomy carries fewer risks than tubal ligation.
However, social, cultural, and individual considerations should
be taken into account before a choice of procedure is made.
(Grade A)
2. Before recommending a transcervical sterilization (cornual
occlusion technique), extensive counselling should be offered
and the permanence of the procedure reinforced. (Grade B)
3. Counselling before sterilization should include discussion of
alternative contraceptive methods. Counselling should address
the risks, complications, potential for regret, and failure rates
associated with the procedure. (Grade B)
4. New techniques of female and male sterilization should be
available to all Canadians. (Grade C)
Chapter 11: Contraception — Meeting Special Needs
Contraception in Perimenopause
1. Health-care providers should emphasize the need for effective
contraception in the perimenopausal woman. Non-contraceptive benefits of each method should be taken into account
when counselling these women. (Grade A)
Postpartum Contraception
1. Initiation of combined OC use should be delayed until breastfeeding is established, usually by 6 weeks postpartum. If the
woman is not breastfeeding, combined OCs can be started at
3 to 4 weeks postpartum. (Grade B)
2. Progestin-only methods should be considered as contraceptive
options for postpartum women, regardless of breastfeeding status, and may be introduced immediately after delivery. (Grade B)
Post-Abortion Contraception
1. Contraceptive counselling should be offered at the time of
abortion, and contraceptive methods should be provided
immediately following the procedure. (Grade A)
2. Canadian women should have access to safe abortion procedures regardless of geographical location. (Grade A)
Contraception for the Adolescent
1. Adolescents should have ready access to contraception and
methods of STI prevention. (Grade A)
2. Health-care providers should respect a patient’s right to confidentiality. (Grade A)
3. The health-care provider should help to ascertain that sexually active adolescents are involved in a consensual relationship
that is free of coercion and abuse. (Grade B)
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Contraception in Individuals with Intellectual Disabilities
1. Health-care providers should include sexual health in the
counselling of women and men with intellectual disabilities,
explore potential coercion and abuse and should provide
counselling to help them avoid coercive and abusive situations.
(Grade B)
J Obstet Gynaecol Can 2004;26(4):347–87.
CHAPTER 8: BARRIER METHODS
Diane Francoeur, MD, FRCSC,1 Louise Hanvey, BN,
MHA,2 Ruth Miller, MEd,3 Helen Pymar, MD, MPH,
FRCSC4
1Montréal
QC
QC
3Toronto ON
4Toronto ON
2Chelsea
Barrier methods of contraception use a mechanical or chemical barrier to obstruct the entry of spermatozoa into the upper
female genital tract. Some of these methods (condoms, spermicides, sponge) do not require consultation with a health-care
provider before use, and are widely available. Others
(diaphragm, cervical cap) require an initial visit to a health-care
provider for fitting. Each method provides variable protection
against both unplanned pregnancy and sexually transmitted
infection (STI).
1. CONDOMS
INTRODUCTION
When placed correctly over the penis, the condom acts as a
mechanical barrier that prevents contact between semen and
the sexual partner. Most condoms are made of latex, although
polyurethane, silicone, and lambskin condoms are available.
The latex condom is the most popular barrier method of
contraception.1 Latex condoms are 0.3–0.8 mm thick. Sperm
cannot penetrate condoms. Latex condoms are offered in a variety of shapes and colours. Novelty condoms, offered in sex toy
supply stores or catalogues do not offer pregnancy and STI prevention.
A number of polyurethane condoms have recently become
available in Canada. These new condoms may offer better physical properties than latex condoms, and thus may be stronger.
They transmit more body heat, allowing more sensitivity. They
can be formulated to feel thinner than they actually are, with a
less constricting fit. They are more resistant to deterioration.
Unlike latex condoms, polyurethane condoms are compatible
with oil-based lubricants. They can be used by those who are
sensitive or allergic to latex.2,3
Three polyurethane condom brands are currently available
in Canada: Avanti, Trojan Supra (lubricated with or without sper348
APRIL 2004
micide), and eZ.on. They cost twice as much as latex condoms.4
Plastic condoms manufactured from materials other than
polyurethane have also been developed. The Tactylon condom,
manufactured from a plastic material used in non-allergenic
examination gloves, was recently approved by the U.S. Food
and Drug Administration.2,5
Lambskin (also called sheepskin or natural membrane) condoms are made from a lamb’s intestine. While both latex condoms and lambskin condoms prevent pregnancy by blocking
the passage of sperm through their surfaces, lambskin condoms
are not recommended for protection against STI. Laboratory
tests have shown the passage of viruses, including hepatitis B,
herpes simplex virus and HIV through small pores on the surface of lambskin condoms.6
STI are inconclusive, but STI rates in populations have been
shown to decline when condoms are used. Condoms lubricated with spermicides are no more effective than latex condoms
without spermicide.11 Latex condoms decrease the risk of transmission of STI associated with vaginal discharge (chlamydia,
gonorrhea, trichomoniasis, and human immunodeficiency
virus).14-16 A lesser level of protection is provided for STI associated with genital ulcer or human papilloma virus (HPV),
because these infections may be transmitted by exposure to areas
such as infected skin or mucosal surfaces that are not covered
by the condom. The ability of condoms to prevent HPV infection is unknown because HPV is often only intermittently
detectable. Nevertheless, condom use has been associated with
lower incidence rates of cervical cancer, genital warts, and cervical dysplasia, all of which are HPV-associated conditions.17-20
Several carefully conducted studies have demonstrated in
vivo and in vitro that consistent condom use is a highly effective means of preventing human immunodeficiency virus
(HIV) transmission. From incidence estimates, consistent use
of condoms can decrease AIDS/HIV transmission by 85%.21-24
EFFICACY
LATEX CONDOMS
The efficacy of condoms refers to both pregnancy prevention
and prevention of sexually transmitted infection.
Condoms are very effective when used consistently and correctly. The percentage of women experiencing an accidental
pregnancy within the first year of perfect use of condoms is estimated at 3%, whereas the typical failure rate is approximately
14%.7 The highest failure rates are from age 20 to 24, while the
second-highest failure rate is under the age of 20.8 Non-use
probably accounts for most of the difference in condom failure
rates between typical and perfect users. Factors positively associated with delayed condom use include younger age, primary
partner, lack of partner support, and multiple recent sexual partners.9 Women identified a low perceived risk of pregnancy or
infection as the most common reason for not using condoms,
while men identified the inconvenience or unavailability of the
condom as the most common reason.10
Condoms used in conjunction with other methods of birth
control will provide additional protection against pregnancy
and possibly STIs, depending on the method used. Ideal use of
the condom with separate spermicide increases the contraceptive efficacy close to that of perfect use of combined oral contraceptives, which is 99.9%.11 The use of intravaginally applied
spermicide, in contrast to spermicide incorporated in condoms,
guarantees its presence in the vaginal region in the event of condom breakage or leakage.11
In 2000, the U.S. Centers for Disease Control and Prevention, the U.S. National Institutes of Health, the U.S. Food and
Drug Administration, and the United States Agency for International Development made clear recommendations regarding
the use of male latex condoms. A summary report was published
in July 2001,12 suggesting that correct and consistent use of
male latex condoms will reduce the risk of sexually transmitted
infections.11,13,14
The data regarding individual use of condoms and risk of
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POLYURETHANE AND OTHER PLASTIC CONDOMS
Comparisons between Avanti polyurethane condoms and latex
condoms showed equivalent levels of contraceptive protection,
but the polyurethane condoms had a higher frequency of breakage and slippage. These condoms may therefore confer less protection from STI than do latex condoms.25-27 The eZ.on
polyurethane condom has not been shown to be as effective as
the latex condom for pregnancy prevention, although the risk
of pregnancy in the polyurethane condom group lies in the
range of other barrier methods. Clinical failures (breakage and
slippage) are also higher for eZ.on polyurethane condoms than
for latex condoms.28,29
Polyurethane and other plastic condoms have not been well
studied for protection against STIs, but they are believed to provide protection similar to that of latex condoms. Studies of their
effectiveness are in progress.
TACTYLON CONDOMS
The Tactylon condoms are equivalent to latex condoms in risk
of slippage, but the breakage rate for the Tactylon condom is
three to five times higher than the latex condom. Fewer medical events (irritation, burning, itching, and genital pain) were
reported with Tactylon condoms than with latex condoms.30,31
LAMBSKIN CONDOMS
Lambskin condoms are no longer recommended because of
their lack of protection against STI.6
MECHANISM OF ACTION
The condom acts as a mechanical barrier to prevent exchange
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APRIL 2004
still common: 43% of users applied the condom after penetration, 15% removed it before ejaculation, 40% did not leave
space at the tip, 30% placed the condom upside down on the
penis and thus rolled it on inside out, and 32% were unable
to maintain erection.37
of fluid and semen and to decrease contact with genital lesions.
While both latex and lambskin condoms prevent pregnancy by
blocking the passage of sperm through their surfaces, lambskin
condoms are not recommended for protection against STIs.6
Laboratory tests have shown the passage of viruses, including
hepatitis B, herpes simplex, and HIV, through small pores on
the surface of lambskin condoms.6 Some condoms are supplied
pre-lubricated with either a water-based lubricant or a small
amount of spermicide. Condom choices include plain or reservoir-tipped, straight or shaped, smooth or textured, natural or
brightly coloured, and a variety of sizes. Some condoms tend to
fit better than others; optimal fitting requires trying a variety of
condoms.
MYTHS AND MISCONCEPTIONS
1. Everybody knows how to use a condom.
Fact: Women, and especially adolescents seem to expect that
all men know how to use the condom correctly to prevent
breakage or spillage, but this is untrue.
2. I can’t get a sexually-transmitted infection if I always use a
condom.
Fact: Some users believe that condoms prevent all STIs, and
they will have intercourse even in the presence of ulcers or
genital lesions. Any skin-to-skin contact can lead to transmission of STIs.
INDICATIONS
Condoms are indicated for the prevention of pregnancy, STI,
and cervical dysplasia. The chief motivation for condom use in
women is pregnancy prevention rather than STI.32
Ideally, condoms should be used in addition to another primary contraceptive method (dual protection), because condom
use potentially increases the contraceptive and STI protective
effects of other methods.
INITIATION
PROVISION OF CONDOMS
Innovative programs have been developed to improve access to
condoms for individuals who find them difficult or embarrassing to purchase. Whether condoms should be readily available
to young people through school-based clinics or dispensing
machines is a matter for debate. It is of interest that the lowest
unwanted pregnancy rates occur in those countries that have
more liberated sexual norms, mandated sex education, and provide easy access to family planning information and services
through school-based clinics.37
CONTRAINDICATIONS
The only contraindication to latex condom use is an allergy or
sensitivity to latex, or lanolin sensitivity in the case of lambskin
condoms. Effective use of condoms requires high motivation
and a strong sense of responsibility.
NON-CONTRACEPTIVE BENEFITS
PROPER USE AND PRECAUTIONS
Use of a condom increases the contraceptive and STI protective effects of other methods. When the use of a condom is
insisted upon, this may have a positive effect on the nature and
duration of the relationship.33
Packaged condoms that are stored dry and away from light and
heat can be kept for up to 5 years. The approved lifespan of spermicide-containing condoms is 2 years. The expiration date must
be respected. Condoms deteriorate more quickly when exposed
to temperatures over 37 degrees Celsius, high humidity, and air
pollution.38 Unpackaged condoms exposed to ultraviolet light
are weakened by 80% to 90% within 8 to 10 hours.39 The most
common error in using condoms is the additional use of oilbased lubricants, which, unlike water lubricants, have been
shown to affect condom integrity by reducing tensile strength,
elongation, burst pressure, and burst volume.40 Table 1 lists
lubricants that are safe or unsafe to use with condoms. Condoms should not be disposed of in toilets.
In case of condom breakage or leakage, emergency contraception should be provided, as well as STI testing if necessary.
SIDE EFFECTS
Side effects with condom use include allergy to latex and irritation. The use of spermicides increases the incidence of E. coli
urinary tract infection because of alteration of the vaginal
flora.34,35 Some men may complain of decreased sensation or
loss of erection.36
RISKS
Technical problems with condom use (occurrence of an unrecognized leak, slippage) are more common when men are not
used to the method.37 Condoms are not always available when
needed. A recent study in college men showed that errors are
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USING A CONDOM
When this is the only contraceptive method selected, a healthcare provider ideally should instruct both the woman and her
350
APRIL 2004
partner in the use of condoms, and should provide the woman
with a prescription for emergency contraception. (See Table 2.)
“USING A CONDOM INTERFERES WITH THE
SPONTANEITY OF SEX.”
Condom use may interfere with, or interrupt, foreplay and impair
erection. Encouraging the partner to put the condom on as a part
of sex play, eroticizing condom use, and using a condom during
sex play before intercourse often alleviates this problem.
TROUBLESHOOTING
The health-care provider should be prepared to deal with comments and concerns voiced by the patient regarding condom use.
Here are some suggestions for dealing with common complaints.
“I AM ALLERGIC TO LATEX.”
While sensitivity may be related to the spermicide or lubricant,
latex sensitivity is increasing, particularly among workers with
repeated exposure to latex medical devices.42 Lambskin condoms may be used for contraception, but polyurethane condoms should be used for STI prevention.
“I DON’T HAVE THE SAME FEELING WITH A
CONDOM.”
While condom use may reduce sensitivity, there is no objective
evidence for this. Reduced sensitivity may be an advantage for
some men by enhancing erection and preventing premature
ejaculation, but others find this frustrating and will stop using
a condom. To increase sensation, the male partner may use a
textured or ultra-thin condom, or place a water-soluble lubricant inside the reservoir of the condom.
“WHAT DO I DO ABOUT CONDOM BREAKAGE AND
SLIPPAGE?”
Most condoms (92%–98%) will neither break nor come off
completely during intercourse.43 The risk of pregnancy has been
estimated at one pregnancy in 23 episodes of condom breakage,
and the probability of HIV infection resulting from a single
exposure ranges from less than 0.1% to 10%, depending on the
type of transmission (male to male, male to female, or female to
male) and the presence or absence of genital ulcers.44,45 STI testing is recommended if there is any fear of infection.
Common reasons for breakage include rough handling of
condoms, the use of oil-based lubricants, and incorrect storage
or usage after the expiry date. While condoms rarely slip off
completely during intercourse, they may slide down the shaft
of the penis without falling off. The condom must be held at
the base of the penis during withdrawal.43 Excessive lubricant
inside the condom will increase the risk of slippage. Emergency
contraception should be recommended if there is doubt.
“I LOSE MY ERECTION WHEN USING A CONDOM.”
Making the application of the condom by the partner a routine
part of sex play — during oral sex or masturbation, for example
— may help overcome this obstacle.
Table 1.41 Lubricants and Products that are Safe or Unsafe to Use
with Condoms
Safe
Unsafe
Aloe-9
Aqua-Lube
Aqua-Lube Plus (spermicidal)
Astroglide
Carbowax
Condom-Mate
Contraceptive foams (e.g.,
Emko, Delfen, Koromax)
Contraceptive creams and gels
(e.g., PrePair, Conceptrol,
Ramses)
Duragel
Egg white
ForPlay lubricant
Glycerin USP
Intercept
Koromex Gel
Lubafax
Lubrin Insert
Norform Insert
Ortho-Gynol
Personal Lubricant
PrePair Lubricant
Probe
Saliva
Semicid
Silicones DC 360
Transi-Lube
Water
Baby oils
Burn ointments
Coconut oil/butter
Edible oils (e.g., olive, peanut,
corn, sunflower)
Fish oils
Haemorrhoid ointments
Insect repellants
Margarine, dairy butter
Mineral oil
Palm oil
Petroleum jelly (e.g., Vaseline)
Rubbing alcohol
Suntan oil
Vaginal creams/spermicides
(e.g., Monistat, Estrace,
Femstat, Vagisil, Premarin,
Rendell’s Cone, Pharmatex
Ovule)
Some sexual lubricants (e.g.,
Elbow Grease, Hot Elbow
Grease, and Shaft
JOGC
“I HAVE TROUBLE CONVINCING MY PARTNER THAT
WE SHOULD USE CONDOMS.”
Health-care providers can rehearse specific scenarios with their
Table 2. Using a Condom
• Put a drop or two of water-based lubricant or saliva inside the
condom
• Place the rolled condom over the tip of the hard penis
• Leave a half-inch space at the tip to collect semen
• If not circumcised, pull back the foreskin before rolling on the
condom
• Pinch the air out of the tip with one hand (friction against air
bubbles causes most condom breaks
• Unroll the condom over the penis with the other hand
• Roll it all the way down to the base of the penis
• Smooth out any air bubbles
• Lubricate the outside of the condom — pull out before the penis
softens
• Don’t spill the semen — hold the condom against the base of the
penis while you pull out
• Throw the condom away
• Wash the penis with soap and water before any further contact
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APRIL 2004
Table 3. How to Talk About Condoms with a Partner
If the partner says …
You can say …
“I’m on the pill. You don’t need a condom.”
“I want to use it anyway. We will be protected from infections we may
not realize we have.”
“What’s more romantic than making love and protecting each other’s
health at the same time?”
“As far as I know, I am disease-free too, but I still want to use a
condom since a person can’t always tell if they have an infection.”
“Maybe that way you’ll last even longer, and that will make up for it.”
OR “I think I am woman (man) enough to make you feel
something.”
“I can do something about that.”
“Condoms aren’t romantic.”
“I know I’m clean of disease. I haven’t had sex with anyone in ‘X’
months.”
“I can’t feel a thing when I use a condom. It’s like wearing a raincoat in
a shower.”
“I don’t stay hard when I put on a condom.”
“Putting it on interrupts everything and destroys the romantic
atmosphere.”
“But I love you.”
“Not if I help put it on.” OR “We can make it erotic together.”
“Then, if you love me, you’ll help me protect myself.”
“I guess you don’t really love me.”
“I do, but I’m not risking my future to prove it.”
“Just this once.”
“Once is all it takes.”
“You carry a condom around with you? You were planning on having
sex?”
“I won’t have sex with you if you insist on using a condom.”
“I always carry condoms because I care about myself and I care about
us.”
“OK. Let’s put it off until we can agree. Let’s satisfy each other without
intercourse.”
“I do.”
“I don’t have a condom with me.”
patients, walk through mentally when and how to purchase
condoms, where to carry them, and when and how to bring up
the subject of condom use. They should teach negotiating skills
when there is resistance to condom use. (See Table 3.)
J Sex Marital Ther 1999;25(3):217–25.
11. Kestelman P,Trussell J. Efficacy of the simultaneous use of condoms and
spermicides. Fam Plann Perspect 1991;23:226–7, 232.
12. National Institute of Allergy and Infectious Diseases, National Institutes
of Health, Department of Health and Human Services. Scientific evidence
on condom effectiveness for sexually transmitted disease (STD) prevention. Available at <www.niaid.nih.gov/dmid/stds/condomreport.pdf>.Web
site updated July 20, 2001. Accessed January 20, 2004.
13. Centers for Disease Control. Update. Barrier protection against HIV
infection and other sexually transmitted diseases. MMWR Morb Mortal
Wkly Rep 1993;42(30):589–91.
14. Kelaghan J, Rubin GL, Ory HW, Layde PM. Barrier-method contraceptives and pelvic inflammatory disease. JAMA 1982;248(2):184–7.
15. Zenilman JM,Weisman CS, Rompalo AM, Ellish N, Upchurch DM,
Hook EW III, et al. Condom use to prevent incident STDs: the validity
of self-reported condom use. Sex Transm Dis 1995;22(1):15–21.
16. Rosenberg MJ, Davidson AJ, Chen JH, Judson FN, Douglas JM. Barrier
contraceptives and sexually transmitted diseases in women: a comparison of female-dependent methods and condoms. Am J Public Health
1992;82(5):669–74.
17. Obasi A, Mosha F, Quigley M, Sekirassa Z, Gibbs T, Munguti K, et al.
Antibody to herpes simplex virus type 2 as a marker of sexual risk
behaviour in rural Tanzania. J Infect Dis 1999;179:16–24.
18. Manhart LE, Koutsky LA. Do condoms prevent genital HPV infection,
external genital warts, or cervical neoplasia? Sex Transm Dis
2002;29(11):725–35.
19. Ho GY, Bierman R, Beardsley L, Chang CJ, Burk RD. Natural history of
cervicovaginal papillomavirus infection in young women. N Engl J Med
1998;338(7):423–8.
20. Jamison JH, Kaplan DW, Hamman R, Eagar R, Beach R, Douglas JM Jr.
Spectrum of genital human papillomavirus infection in a female adolescent population. Sex Transm Dis 1995;22(4):236–43.
21. Allen S,Tice J,Van de Perre P, Serufilira A, Hudes E, Nsengumuremyi F,
et al. Effect of serotesting with counselling on condom use and
seroconversion among HIV discordant couples in Africa. BMJ 1992;
304(6842):1605–9.
22. de Vincenzi I. A longitudinal study of human immunodeficiency virus
transmission by heterosexual partners. N Engl J Med 1994;331:341–6.
23. Deschamps MM, Pape JW, Hafner A, Johnson WD Jr. Heterosexual
REFERENCES
1. Fisher W, Boroditsky R, Morris B.The 2002 Canadian Contraception
Study. J Obstet Gynaecol Can. In press 2004.
2. McNeill ET, Gilmore CE, Finger WR, Lewis JH, Schellstede WP.The latex
condom: recent advances, future directions. Available on-line at:
http://www.fhi.org/en/RH/Pubs/booksReports/latexcondom/index.htm.
Web site updated 2003. Accessed January 23, 2004.
3. Rosenberg MJ,Waugh MS, Solomon HM, Lyszkowski ADL.The male
polyurethane condom: a review of current knowledge. Contraception
1996; 53:141–6.
4. Health Canada. Listing of Medical Devices Licenses. Available on-line at:
<http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/mdlic_e.html>.Web site
updated November 27, 2003. Accessed January 23, 2004.
5. Food and Drug Administration, Department of Health and Human Services. Lubricated baggy condom: summary of safety and effectiveness,
Sensicon Corporation submission. Directory of Medical Devices; 1997.
6. Cates W, Stone KM. Family planning, sexually transmitted diseases, and
contraceptive choice: a literature update, part 1. Fam Plann Perspect
1992;24:75-84.
7. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
8. Trussell J. Contraceptive efficacy. In: Hatcher RA,Trussell J, Stewart F,
Cates W, Stewart GK, Guest F, et al, editors. Contraceptive technology.
17th ed. New York, NY: Ardent Media; 1998. p. 779–844.
9. Civic D, Scholes D, Ichikaw L, Grothaus L, McBride CM,Yarnall KS,
Fish L. Ineffective use of condoms among young women in managed
care. AIDS Care 2002;14(6):779–88.
10. Carter JA, McNair LD, Corbin WR,Williams M. Gender differences
related to heterosexual condom use: the influence of negotiation styles.
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Female Condom is the only product of this kind available in
Canada. Like the condom for men, the female condom can be
bought in pharmacies without prescription.
transmission of HIV in Haiti. Ann Intern Med 1996;125:324–30.
24. Saracco A, Musicco M, Nicolosi A, Angarano G, Arici C, Gavazzeni G,
et al. Man-to-woman sexual transmission of HIV: longitudinal study of
343 steady partners of infected men. J Acquir Immune Defic Synd
1993;6(5):497–502.
25. Frezieres RG,Walsh TL, Nelson AL, Clark VA, Coulson AH. Breakage
and acceptability of a polyurethane condom: a randomized, controlled
study. Fam Plann Perspect 1998;30(2):73–8.
26. Frezieres RG,Walsh TL, Nelson AL, Clark VA, Coulson AH. Evaluation
of the efficacy of a polyurethane condom: results from a randomized,
controlled clinical trial. Fam Plann Perspect 1999;31:81–7.
27. Frezieres RG,Walsh TL. Acceptability evaluation of a natural rubber
latex, a polyurethane, and a new non-latex condom. Contraception
2000;61(6):369–77.
28. Steiner MJ, Dominik R, Rountree RW, Nanda K, Dorflinger LJ. Contraceptive effectiveness of a polyurethane condom and a latex condom: a
randomized controlled trial. Obstet Gynecol 2003;101(3):439–47.
29. Cook L, Nanda K, and Taylor D. Randomized crossover trial comparing
the eZ.on plastic condom and a latex condom. Contraception 2001;
63(1):25–31.
30. Callahan M, Mauck C,Taylor D, Frezieres R,Walsh T, Martens M. Comparative evaluation of three Tactylon condoms and a latex condom during vaginal intercourse: breakage and slippage. Contraception 2000;
61(3):205–15.
31. Macaluso M, Blackwell R, Carr B, Meinzen-Derr J, Montgomery M,
Roark M, et al. Safety and acceptability of a “baggy latex condom.”
Contraception 2000;61(3):217–23.
32. Diaz S. Contraceptive technology and family planning services.
Int J Gynaecol Obstet 1998;63 Suppl 1:S85–90.
33. Hocking JE,Turk D, Ellinger A.The effects of partner insistence of condom usage on perceptions of the partner, the relationship, and the
experience. J Adolesc 1999;22(3):355–67.
34. Handley MA, Reingold AL, Shiboski S, Padian NS. Incidence of acute urinary tract infection in young women and use of male condoms with
and without nonoxynol-9 spermicides. Epidemiology 2002;13(4):431–6.
35. Hooton TM, Hillier S, Jonhson C, Roberts PL, Stamm WE. Escherichia
coli bacteriuria and contraceptive method. JAMA 1991;265(1):64–9.
36. Warner L, Clay-Warner J, Boles J,Williamson J. Assessing condom use
practices. Implications for evaluating method and user effectiveness. Sex
Transm Dis 1998;25(6):273–7.
37. Crosby RA, Sanders SA,Yarber WL, Graham CA. Condom use errors
and problems among college men. Sex Transm Dis 2002;29(9):552–7.
38. Carey RF. Background information, FDA testing of latex condoms. Distributed by KR Foster, Health and Welfare Canada; December 1992.
39. Duribon NE.The condom barrier. Am J Nurs 1987;87:1306–10.
40. Voeller B, Coulson A, Bernstein GS, Nokamura R. Mineral oil lubricants
cause rapid deterioration of latex condoms. Contraception 1989;
39:95–101.
41. Waldron T.Tests show commonly used substances harm latex
condoms. Contraceptive Technology Update 1989;10:20–1.
42. U.S. Food and Drug Administration. Allergic reactions to latex containing medical devices. March 29, 1991. Publication No.: MDA91-1.
43. Trussell J,Warner DL, Hatcher RA. Condom slippage and breakage
rates. Fam Plann Perspect 1992;24:20–3.
44. Hatcher RA, Hughes MS.The truth about condoms.The Sexuality Information and Education Council of the U.S. SIECUS Report 1998;17:1–9.
45. Liskin L,Wharton C. Blackburn R. Kestelman P. Condoms: now more
than ever. Pop Rep 1990;8, Series H.
EFFICACY
Contraceptive failure rates for the female condom vary across
studies. The use of the female condom for contraception is
approximately as effective as the use of the male condom, and
it is more effective than vaginal spermicidal methods. The
12-month pregnancy rate for perfect (correct and consistent)
use of the female condom is 5%, compared to 3% for the male
condom and 6% with use of the diaphragm.1 The 12-month
pregnancy rate for typical use is similar to the diaphragm with
spermicide (20%), but not as effective as the condom for men
(14%).1-5 These rates are much lower than those reported in
previous studies.6
MECHANISM OF ACTION
The female condom is a polyurethane sheath which is placed
in the vagina. It lines the vagina completely, preventing contact
between the penis and vagina. The condom traps semen and is
then discarded.
The female condom is 7.8 cm in diameter and 17 cm long.
It has 2 flexible rings, one attached to the sheath and one unattached. The attached external ring at the open end of the condom sits outside the vagina and provides some protection to the
perineum. The unattached ring lies within the closed end of the
pouch, allowing the condom to be inserted into the vagina and
kept in place. The sheath is coated on the inside with a siliconebased lubricant. The condom can be placed in the vagina up to
8 hours before intercourse.4,7
The polyurethane used in the female condom is less likely
to tear or break than the latex in male condoms. In a study of
post-intercourse leakage designed to detect pinholes and tears
after actual condom use, 3.5% of male latex condoms showed
leakage when tested after use, compared with 0.6% of female
condoms.8 The female condom does not deteriorate with exposure to oil-based products, and withstands storage better than
latex. It has a longer shelf-life (of up to 5 years) than the male
condom. It should be noted that the female condom is not
intended for use with a male condom, because the two condoms may adhere to one another and slip or become displaced.
INDICATIONS
2. FEMALE CONDOM
The female condom prevents semen from contacting the vagina. A woman who finds spermicides irritating, or does not like
the messiness of other vaginal barrier methods, may prefer to
use the female condom.
Advantages of the female condom include the following:
INTRODUCTION
The female condom is a soft, loose-fitting polyurethane sheath
which acts as an intravaginal barrier. (See Figure 1.) The Reality
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• A woman can place it autonomously and has full control
of the effectiveness.
• When used correctly, it can provide a high level of protection.
• It adjusts well to the anatomy of the vagina.9
Disadvantages of the female condom include
• the need to practise insertion and to use the device several
times before becoming confident with its use
• the inner ring may cause discomfort during coitus9
• cost
• noise during coitus16
Promotion of use of the female condom has been met with
challenges such as the perceived high cost (approximately $3.00
per condom in Canada). There is also evidence of bias against
the method on the part of health-care providers .17 Their attitudes may improve through more positive and well-designed
training programs.18
CONTRAINDICATIONS
Some conditions prohibit the use of the female condom.
They are:
• Allergy to polyurethane
• Abnormalities in vaginal anatomy that interfere with a
satisfactory fit or stable placement
• Inability to learn the correct insertion technique.
INITIATION
Women who plan to use female condoms do not require a fitting, but they need to:
• understand how to use them correctly
• insert them just prior to intercourse or up to 8 hours
before
• use a new condom for each act of intercourse
• remove the female condom immediately after intercourse,
squeezing and twisting the outer ring to keep semen
inside the pouch, before standing up
NON-CONTRACEPTIVE BENEFITS
PROTECTION FROM SEXUALLY TRANSMITTED
INFECTION
Polyurethane is impenetrable in vitro to organisms the size of the
human immunodeficiency virus (HIV).10 The female condom
provides protection from sexually transmitted infection (STI) that
is similar to that of the male condom, although specific clinical
evidence is limited. The incidence of STI in sex workers given the
choice of using male or female condoms has been reported lower
than the incidence in women using male condoms only.11,12
TROUBLESHOOTING
If the female condom slips or breaks, women should be counselled to use emergency contraception.
WOMEN’S EMPOWERMENT
One of the most important features of the female condom is
that it is a female-controlled method of contraception and STI
prevention.9,13-15
ACCEPTABILITY
Acceptability varies with study groups. For example, female condoms are well-accepted in sex workers, a group in which as
many as 98% were satisfied with the method.16 The percentage of satisfaction went down to as little as 65.2% in a survey
of volunteers from hospital staff.19
SIDE EFFECTS, RISKS, AND CHALLENGES
Problems are uncommon with the use of the female condom.
Slippage has been cited as a problem specific to the use of the
female condom.7
COST
Like the male condom, the female condom is made for single
use only, so the cost of sustained use can be prohibitive. In
Canada the average cost is $3.00 per condom. Re-using the
female condom has been considered as one approach to make
the female condom more cost-effective; the safety and feasibility of re-use is currently the subject of research.20,21
REFERENCES
1. The World Health Organization. Improving access to quality care in
family planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
2. Bounds W, Guillebaud J, Stewart L, Steele SJ. A female condom
(Femshield): a study of its user-acceptability. Br J Fam Plann, 1988;14:83–7.
3. Farr G, Gabelnick H, Sturgen K, Dorflinger L. Contraceptive efficacy and
acceptability of the female condom. Am J Public Health 1994;84(12):1960–4.
Figure 1. The Female Condom
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which is the most common; the arcing spring; and the flat
spring. The coil spring diaphragm has a sturdy rim which folds
easily for insertion. It remains in a straight line when pinched
at the edges. Women need good pelvic support to feel comfortable with this type of diaphragm, because it is difficult to
secure the posterior edge into the cul-de-sac over the cervix. It
is often preferred by parous women.
The arcing spring diaphragm slips more easily past the
cervix and is easier to use for most women.1 It is more suitable
for nulliparous women.
A flat spring diaphragm (also called a wideseal diaphragm)
made of silicone is an option for women who are allergic to
latex, and is available over the Internet.2
Ultimately, the choice of diaphragm will be based on individual preferences for comfort and ease of checking for position.
A diaphragm can be inserted into the vagina with an introducer, but the manual method of insertion is superior because it
offers the user the opportunity to check for fit. (See Figure 2.)
4. Gilliam ML, Derman RJ. Barrier methods of contraception. Obstet
Gynecol Clin North Am 2000;27(4):841–58.
5. Family Health International.Technical update on the female condom.
Available on-line at <http://www.fhi.org/en/RH/Pubs/booksReports
/fcupdate.htm>.Web site updated December 18, 2001. Accessed
January 26, 2004.
6. Trussell J, Sturgen K, Strickler J, Dominik R. Comparative contraceptive
efficacy of the female condom and other barrier methods. Fam Plann
Perspect 1994;26(2):66–72.
7. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al,
editors. Contraceptive technology. 17th ed. New York, NY: Ardent
Media; 1998.
8. Leeper MA, Conrardy M. Preliminary evaluation of Reality, a condom
for women to wear. Adv Contracept 1989;5(4):229–35.
9. Gollub EL.The female condom: tool for women’s empowerment. Am J
Public Health 2000;90(9):1377–81.
10. Drew WL, Blair M, Miner RC, Conant M. Evaluation of the virus permeability of a new condom for women. Sex Transm Dis 1990;17(2):110–2.
11. Fontanet AL, Saba J, Chandeying V, Sakhondavat C, Bhiraleus P, Rugpao S.
Increased protection against sexually transmitted diseases by granting
sex workers in Thailand the choice of using the male or female
condom: a randomized controlled trial. AIDS 1998;12:1851–9.
12. Welsh MJ, Feldblum PJ, Kuyoh MA, Mwarogo P, Kungu D. Condom use
during a community intervention trial in Kenya. Int J STD AIDS
2001;12(7):469–74.
13. Musabe E, Morrison CS, Sunkutu MR,Wong EL. Long-term use of the
female condom among couples at high risk of human immunodeficiency
virus infection in Zambia. Sex Transm Dis 1998;25:1–5.
14. Artz L, Macaluso M, Brill I, Kelaghan J, Austin H, Fleenor M, et al. Effectiveness of an intervention promoting the female condom to patients
at sexually transmitted disease clinics. Am J Public Health 2000;90:
237–44.
15. Latka M, Gollub E, French P, Stein Z. Male and female condom use
among women after counselling in a risk reduction hierarchy for STD
prevention. Sex Transm Dis 2000;27(8):431–7.
16. Zachariah R, Harries AD, Buhendwa L, Spielman MP, Chantulo A,
Bakali E. Acceptability and technical problems of the female condom
amongst commercial sex workers in a rural district of Malawi.Trop
Doct 2003;33(4):220–4.
17. Latka M. Female-initiated barrier methods for the prevention of
STI/HIV: where are we now? where should we go? J Urban Health
2001;78(4):571–80.
18. Mantell JE, Hoffman S,Weiss E, Adeokun L, Delano G, Jagha T, et al.The
acceptability of the female condom: perspectives of family planning
providers in New York City, South Africa, and Nigeria. J Urban Health
2001;78(4):658–68.
19. Sapire KE.The female condom (Femidom): a study of user acceptability.
S Afr Med J 1995;85(10 Suppl):1081–4.
20. International Planned Parenthood Federation. IMAP statement on barrier methods of contraception. IPPF Med Bull 2001;35(4):1.
21. World Health Organization.The safety and feasibility of female condom
reuse: report of a WHO consultation. Geneva:WHO; 2002.
EFFICACY
Efficacy rates vary depending on the study and the methodology used. The WHO failure rate for the diaphragm in the first 12
months of use is 20% with typical use and 6% with perfect use.3
While consistent and correct use of the diaphragm is essential for effectiveness, approximately one-half of method failures
occur despite diligent use. Therefore, a woman’s ability to accept
an unplanned pregnancy may be a determinant in her suitability for this barrier method.
A recent study found use of the diaphragm and spermicide
to provide significantly more effective contraception than use
of the contraceptive sponge.4
MECHANISM OF ACTION
The diaphragm serves as a physical barrier between sperm and
the cervix and should always be used in conjunction with a spermicide. The spermicidal action of the jelly or cream used
increases the contraceptive effect. In addition, the use of a
diaphragm is associated with a reduced incidence of cervical
neoplasia,1,6 dysplasia,6,7 gonorrhea,8 pelvic inflammatory disease,9 and tubal infertility.10
The use of a diaphragm without the addition of a spermicidal agent shows variable contraceptive effectiveness.11,12 A
recent review found no rigorous studies which were able to distinguish the effectiveness of the device with as opposed to without spermicide.13 Diaphragms should always be used together
with a spermicide.14
A diaphragm can be inserted up to 6 hours before intercourse.5 Each repeated act of intercourse requires the application
of extra spermicide (an applicator is necessary for this repeat
insertion).
3. DIAPHRAGM
INTRODUCTION
The diaphragm is an intravaginal barrier method of contraception that is used in conjunction with a spermicide (jelly or
cream). It consists of a latex dome with an encased flexible steel
ring around its edge. It fits into the vagina to cover the cervix.
Diaphragms are available in a variety of sizes and types. The
three types of diaphragm available in Canada are the coil spring,
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A refitting of the diaphragm is required after childbirth,
surgery, or if the woman gains or loses at least 10 pounds.
diaphragm’s rim on the urethra and the concurrent use of spermicides.15 Of these, the use of a spermicide may be a more
important cause.1
The diaphragm is contraindicated for women or their partners who have allergies or sensitivities to latex, rubber, or spermicides.
Use of a diaphragm can be associated with toxic shock syndrome
(TSS). Toxic shock syndrome, caused by toxins released by some
strains of Staphylococcus aureus, is a rare but serious disorder. The
risk of TSS, although low, is increased in women who use vaginal barrier methods of contraception.
INDICATIONS
Diaphragms are well suited for those women who do not wish
to use hormonal contraception or for whom hormonal contraception is contraindicated.1 Diaphragms can also be used by
breastfeeding women.
CONTRAINDICATIONS AND CAUTIONS
The health-care provider must rule out the presence of a large
cystocele, rectocele, or marked uterine prolapse,10 which would
reduce the efficacy of the method.
Some women are sensitive to spermicides and to latex.
There is also evidence of an increased risk of developing
bacterial vaginosis in diaphragm users. 15 Women with
recurrent urinary tract infections (UTI) may need postcoital
prophylaxis with antibiotics, since there is a 2 to 3 fold
increase in UTI risk with the use of spermicides. This is
probably related to changes in the vaginal flora and
increased growth of E. coli.16,17
MYTHS AND MISCONCEPTIONS
1. All barrier methods protect against HIV infection.
Fact: Protection from HIV is limited because of the exposure of vaginal mucosa.
2. Using a diaphragm alone (without spermicide) is equally
effective.
Fact: Studies suggest a decreased efficacy when used alone.14
INITIATION
A pelvic examination by a qualified clinician is required for fitting diaphragms. (See Table 4.) Fitting rings are produced by
diaphragm manufacturers in various sizes and with different rim
types. Sizes range from 50 to 105 mm in diameter. The fitting
rings are most commonly available as flat spring or coil spring
rim types. It is important to fit the woman with the rim type
that she will ultimately use, and to have her practise with it
under the supervision of the clinician.
A sample sized diaphragm or fitting ring can then be inserted into the correct position in the vagina. The diaphragm
should fit snugly in the upper half of the vagina, immediately
behind the pubic bone, with its rim in contact with the lateral
walls of the vagina and the posterior fornix.1
Before a woman can successfully use the diaphragm or cervical cap, she will require detailed instructions for insertion, the
opportunity to practise, and reassurance from the clinician.
Reinforcement of the correct procedures is valuable, as are tips
to becoming more comfortable with one’s body. Providing
information about the menstrual cycle will help women use
their barrier method more effectively. Providing information
NON-CONTRACEPTIVE BENEFITS
The use of a diaphragm offers potential protection from STIs
and their consequences by decreasing cervical exposure to the
causative organisms. Protection from HIV transmission is limited because of the exposure of the vaginal mucosa during the
use of this method. The use of the diaphragm is also associated
with a reduced incidence of cervical neoplasia.6,7
RISKS AND SIDE EFFECTS
The use of a diaphragm may also increase the risk of persistent
or recurrent UTI, possibly because of pressure from the
Table 4. Fitting for a Diaphragm
The correct diaphragm size can be estimated by
• inserting the index and middle fingers into the vagina until the
posterior wall is reached (by middle finger);
• marking the point at which the index finger touches the pubic
bone with the tip of the thumb; and
• removing the fingers, then placing rim of diaphragm on tip of
the middle finger. The opposite side rim should be lying just in
front of the thumb.
Figure 2. Diaphragm
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about the availability of emergency (post-coital) contraception
will also be essential.
Diaphragm users do not require any special follow-up other
than a refitting after a full-term pregnancy, pelvic surgery, or
abortion, or if they have a significant change in weight.
4. CERVICAL CAP
INTRODUCTION
The cervical cap is a barrier method of contraception used
intravaginally in conjunction with a spermicide (jelly or cream).
(See Figure 3b.) The only cervical cap approved by Health
Canada is the Ovès contraceptive cap, which is available
through the Internet.1
TROUBLESHOOTING
If a diaphragm user is experiencing recurrent UTIs, a refit or
change of rim type may help, but the problem may be due to
spermicide exposure. Post-coital voiding or prophylactic antibiotic may help.17 For some women, having recurrent UTIs may
be a contraindication to diaphragm use.
EFFICACY
The World Health Organization cites a contraceptive failure
rate of 20% with typical use and 9% with perfect use in nulliparous women. The failure rate for multiparous women in the
first 12 months of use of the cap is 40% with typical use and
26% with perfect use.2
REFERENCES
1. Speroff L, Darney PD. A clinical guide for contraception. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2001. p. 259–95.
2. Available on-line at <http://www.milexproducts.com/products/other
/diaphrams.asp>. Accessed January 28, 2003.
3. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
4. Kuyoh MA,Toroitich-Ruto C, Grimes DA, Schultz KF, Gallo MF. Sponge
versus diaphragm for contraception: a Cochrane review. Contraception
2003;67(1):15–8.
5. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al,
editors. Contraceptive technology. 17th ed. New York, NY: Ardent
Media; 1998. p. 371–404.
6. Wright NH,Vessey MP, Kenward B, Mc Pherson K, Doll R. Neoplasia
and dysplasia of the cervix uteri and contraception: a possible protective effect of the diaphragm. Br J Cancer 1978;38(2):273–9.
7. Becker TM,Wheeler CM, McGough NS, Stidley CA, Parmenter CA,
Dorin MH, et al. Contraceptive and reproductive risks for cervical
dysplasia in southwestern hispanic and non-hispanic white women.
Int J Epidemiol 1994;23(5):913–22.
8. Keith L, Berger G, Moss W. Prevalence of gonorrhea among women
using various methods of contraception. Br J Venereal Dis 1975;51:
307–9.
9. Keleghan J, Rubin GL, Ory HW, Layde PM. Barrier method contraceptives and pelvic inflammatory disease. JAMA 1982;248:184–7.
10. Kost K, Forrest JD, Harlap S. Comparing the health risks and benefits of
contraceptives choices. Fam Plann Perspect 1991;23:54–61.
11. Ferreira AE, Araujo MJ, Regina CH, Diniz SG. Effectiveness of the
diaphragm, used continuously, without spermicide. Contraception
1993; 48(1):29–35.
12. Smith C, Farr G, Feldblum PJ, Spence A. Effectiveness of the nonspermicidal fit free diaphragm. Contraception 1995;51:289–91.
13. Cook L, Nanda K, Grimes D. Diaphragm versus diaphragm with
spermicides for contraception. Cochrane Database Syst Rev 2003;(1)
CD002031.
14. Craig S, Hepburn S.The effectiveness of barrier methods of
contraception with and without spermicide. Contraception
1982;26:347–59.
15. Hooton TM, Finh SD, Johnson C, Roberts PL, Stamm WE. Association
between bacterial vaginosis and acute cystitis in women using
diaphragms. Arch Intern Med 1989;149(9):1932–6.
16. Hooton TM, Hillier S, Johnson C, Roberts P, Stamm WE. Escherichia coli
bacteriuria and contraceptive methods. JAMA 1991;265:64–9.
17. Finh SD, Latham RH., Roberts P, Running K, Stamm WE. Association
between diaphragm use and urinary tract infection. JAMA
1985;254:240–5.
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MECHANISM OF ACTION
The Ovès cap is made of silicone and places a physical barrier
between sperm and the cervix; the spermicidal action of the jelly
or cream increases the contraceptive effect. The cap is held in
place over the cervix by suction and must therefore be snugly
fitted. It can be left in place for up to 72 hours.
INDICATIONS
Women who do not wish to use hormonal contraception, or
for whom it is contraindicated, may choose to use this barrier
method. It must be used consistently and correctly. A woman’s
ability to accept an unplanned pregnancy may be a determinant
in her suitability for a barrier method such as the cervical cap.
Cervical caps can be used by lactating women.
CONTRAINDICATIONS AND CAUTIONS
The cervical cap should not be used in women with a current
vaginal or cervical infection, current pelvic inflammatory disease,
cervical or uterine cancer or dysplasia, or in women with allergy
or sensitivity to spermicides. Additionally, it is not recommended in a woman who has recurrent vaginal, cervical, or urinary tract
infections, who does not feel comfortable touching her genital
area; or who has difficulty applying the cap to the cervix.
The cervical cap cannot be used within 6 weeks of a delivery, after a recent miscarriage or an abortion, or during any vaginal bleeding including menstruation.
NON-CONTRACEPTIVE BENEFITS
The cervical cap offers potential protection from gonorrheal
and chlamydial infections and their consequences.3
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RISKS AND SIDE EFFECTS
MYTHS AND MISCONCEPTIONS
Use of the cervical cap may aggravate symptoms in women with
sexually transmitted infections and vaginitis. The risk of toxic
shock syndrome is increased. Cervical caps may cause more
vaginal odour and discharge than diaphragms, and can be dislodged during intercourse. Concerns about abnormal cervical
cytology associated with cervical cap use have been shown to be
unfounded.4,5
1. Cervical caps increase the risk of cervical dysplasia.
Fact: Cervical caps are not associated with an increased risk
of cervical cancer, although inflammatory changes have been
reported.3-5
2. It is impossible to obtain a cervical cap in Canada.
Fact: Cervical caps are available in Canada in some family
planning clinics and they can also be ordered through the
Internet.1
Table 5. Fitting for a Contraceptive Cervical Cap
Most women will use the 28 mm cervical cap. The rim of the
cervical cap should be seated in the vaginal fornices around the
entire base of the cervix with a snug seal and no laxity.
Table 6. Instructions for Inserting a Cervical Cap
1. Wash your hands carefully before inserting or removing the
cap.
2. To make it easier to insert or remove the cap, stand with one
leg supported higher than the other (using a chair or the edge
of the bath) or use a squatting position.
3. Remove the cap from its protective sachet.
4. It is recommended that the cap be used with a spermicidal
gel or cream. Place a small amount of the spermicide
recommended by your health-care professional inside the
dome.
5. No additional spermicide is required during the 72-hour
wearing period.
6. Locate the cervix by inserting a finger inside your vagina.
7. Pinch the cap at its base with the dome facing downwards.
8. Introduce the cap into the vagina and push it toward the
cervix.
9. When the bottom of the cap comes into contact with the
cervix, position the cap so that it covers the cervix correctly.
10. When the cap cannot be pushed any further, you will know
that it is placed correctly.
11. Now carefully remove your finger without disturbing the
position of the cap.
Figure 3a. Inserting a cervical cap
Table 7. Instructions for Removing a Cervical Cap
1. The cap must not be removed until at least 6 hours after the
most recent sexual intercourse.
2. Introduce the index finger into the vagina and find the cervix
covered by the cap.
3. Run your finger around the base of the cap until you locate the
loop.
4. Hook the loop of the cap with the end of the index finger.
5. Remove the cap using a slow steady movement.
6. Remove the cap, wash it with warm soapy water and store the
cap in a dark and cool place.
The cap may stay in place for a minimum of 6 hours after the last
intercourse but no longer than 2 days. If an odour develops
after 6 hours, a break and a bath are recommended.
After cleaning and drying the device it can be used again as
described.
A woman with a very busy sex life who cannot wait should
consider another method.
The cervical cap can be reused until it is damaged.
Figure 3b. Cervical caps
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pregnated with a combination of spermicidal agents
(nonoxynol-9, benzalkonium chloride, and sodium cholate).1
The Today Sponge is pillow-shaped and contains nonoxynol-9.
The concave dimple on one side is designed to fit over the cervix
and to decrease the chance of dislodgement during intercourse.
The other side of the sponge incorporates a woven polyester loop
to facilitate removal. (See Figure 4.)
INITIATION
A bimanual pelvic examination must be performed by a qualified clinician to ascertain the position and size of the uterus
and cervix. Some abnormalities of the cervix, such as a large
Nabothian follicle, may interfere with the ability of the cervical cap to cover and adhere to the cervix. Three sizes of cervical caps are available: these are 26, 28, and 30 mm in diameter.
Women can bring a “fitting pack” containing one of each size
cap to the examination to be sure they are fitted with the correct size.
Before a woman can successfully use the cervical cap, she
will require detailed instructions for insertion, the opportunity
to practise, and reassurance from the clinician. (See Figure 3a,
Tables 6 and 7.) Providing information about the availability of
emergency (post-coital) contraception will also be essential. The
combination of a female barrier method with a male latex condom will provide additional contraception and additional protection from sexually transmitted infection.
EFFICACY
The Protectaid sponge has a theoretical efficacy rate of 90%2 in
nulliparous women, but it is much less effective in parous
women — 20% of whom conceive unexpectedly within the
first year of “perfect” use. The actual failure rates for typical users
are 18% for nulliparous women and 36% for parous women.3,4
The Today Sponge has a theoretical efficacy rate of 91% in
nulliparous women, but 20% of parous women conceive unexpectedly within the first year of “perfect” use. The actual failure
rates for typical users are 40% in parous users and 20% in
nulliparous women.3 As with other female barrier methods, efficacy rates can be increased by using the sponge in combination
with a male condom.3 A recent review of clinical trials found
that the sponge was less effective than the diaphragm in preventing pregnancy, and discontinuation rates were higher.5
TROUBLESHOOTING
The manufacturer recommends that cervical cap users have a
health-care provider check the fitting of the cap after a miscarriage, term delivery, abortion, or after gaining or losing 3 kg or
more in weight.
Cervical caps users should be monitored for cervical inflammation and abnormal Pap smears, since inflammatory changes
have been reported.3
MECHANISM OF ACTION
The contraceptive action of the sponge is primarily provided by
the action of the impregnated spermicide, augmented by its
ability to absorb and trap sperm. The sponge acts as a sustainedrelease spermicidal reservoir for a period of 12 hours.
REFERENCES
1. <www.birthcontrol.com>. Accessed January 27, 2004.
2. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
3. Kelaghan J, Rubin GL, Ory HW, Layde PM. Barrier method contraceptives and pelvic inflammatory disease. JAMA 1982;248:184–7.
4. Richwald GA, Greenland S, Gerber MM, Potik R, Kersey L, Comas MA.
Effectiveness of the cavity-rim cervical cap: results of a large clinical
study. Obstet Gynecol 1989;74:143–8.
5. Gollub EL, Sivin I.The Prentif cervical cap and Pap smear results: a critical appraisal. Contraception 1989;40:343–9.
INDICATIONS
The sponge may best meet the needs of women who wish to
or must avoid hormonal contraception. 3 Some women
choose the sponge because of its prolonged 12 hours of protection. It is less messy than spermicide used alone or with a
5. CONTRACEPTIVE SPONGE
INTRODUCTION
The contraceptive sponge is an intravaginal one-size-fits-all barrier method which does not require a visit to a physician or birth
control clinic. The sponge is available in pharmacies.
There are 2 forms of the contraceptive sponge available in
Canada — both are small, disposable polyurethane foam devices
intended to fit over the cervix. The Protectaid sponge is imJOGC
Figure 4. Contraceptive Sponge
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cervical cap or diaphragm. The sponge may be used with
other barrier methods such as the male condom to increase
its efficacy.
Douching after intercourse is not recommended. If sponge
users choose to douche, they should wait for at least 6 hours
after intercourse to avoid the removal of spermicide. They can
use male condoms with the sponge for added protection against
both pregnancy and sexually transmitted infection.
Before insertion, the Today Sponge should be moistened
with about 2 tablespoons of clean water and squeezed once. The
user should insert the dimpled side so that it faces the cervix,
with the loop away from the cervix. She can use her finger to
confirm that the sponge covers the cervix.
CONTRAINDICATIONS
The sponge should not be used by women who have
• an allergy to spermicide
• abnormalities in vaginal anatomy that interfere with satisfactory or stable placement of the sponge
• an inability to learn correct insertion technique
• a history of toxic shock syndrome
• repeated urinary tract infections
• a need for protection from HIV infection
• had a full-term delivery within the past 6 weeks, a recent
spontaneous or induced abortion, or abnormal vaginal
bleeding3
TROUBLESHOOTING
Recurrent vaginal yeast infections or bacterial vaginosis must be
appropriately treated. This may require switching to another
method of contraception.3,8
REFERENCES
RISKS AND SIDE EFFECTS
1. Courtot AM, Nikas G, Gravanis A, Psychoyos A. Effects of cholic acid
and “Protectaid” formulations on human sperm motility and ultrastructure. Hum Reprod 1994;9(11):1999–2005.
2. Guerrero E.The new Protectaid contraceptive sponge: a scientific
update. Press Release.Toronto; February 13, 1996.
3. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al,
editors. Contraceptive technology. 17th ed. New York, NY: Ardent
Media; 1998.
4. Creeatsas G, Guerrero E, Guilbert E, Drouin J, Serfaty D, Lemiex L, et al.
A multinational evaluation of the efficacy, safety and acceptability of the
Protectaid contraceptive sponge. Eur J Contracept Reprod Health Care
2001;6(3):172–82.
5. Kuyoh MA,Toroitich-Ruto C, Grimes DA, Schulz KR, Gallo MG. Sponge
versus diaphragm for contraception (Cochrane Review). Contraception
2003;67:15–8.
6. Schwartz B, Gaventa S, Broome CV, Reingold AL, Hightower W,
Perlman JA, et al. Nonmenstrual toxic shock syndrome associated with
barrier contraceptives: report of a case-control study. Rev Infect Dis
1989;11 Suppl 1:S43–8.
7. Daly CC, Helling-Giese GE, Mati JK, Hunter DJ. Contraceptive methods
and the transmission of HIV: implications for family planning. Genitourin
Med 1994;70:110–7.
8. Mengel MB, Davis AB. Recurrent bacterial vaginosis: association with
vaginal sponge use. Fam Pract Res J 1992;12(3): 283–8.
The risk of toxic shock syndrome (TSS) is increased in women
who use vaginal barrier methods of contraception; they have an
annual incidence of 2 to 3 cases per 100 000 women. The overall health risks attributable to TSS are very low. These cases of
TSS would result in less than 1 death (0.18) annually for every
100 000 vaginal barrier users.6
Women using the sponge must be aware of the symptoms
and signs of TSS, and must receive instructions consistent with
recommended TSS precautions.
MYTHS AND MISCONCEPTIONS
1. Sponges offer protection against STIs.
Fact: The contraceptive sponge may potentially damage vaginal mucosa and thus may enhance HIV transmission.7
INITIATION
Women using the contraceptive sponge need to know how to
insert and use it correctly. They should
• be aware that the sponge provides effective contraceptive
protection for 12 hours, regardless of the number of acts
of intercourse.
• wash their hands carefully with soap and water before
inserting, checking, or removing the sponge.
• remove and discard the sponge after use; sponges should
not be reused.
• ensure that the device is in place before the penis enters
the vagina.
• be familiar with the signs of toxic shock syndrome.
• discuss problems of recurring bladder infections or vaginal yeast infections with their health-care provider.
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6. SPERMICIDES
INTRODUCTION
Spermicides are composed of a spermicidal agent in a carrier
that allows dispersion and retention of the agent in the vagina.
Nonoxynol-9 (N-9) is the most commonly used spermicidal
agent in Canada. Spermicides are easily obtained without a prescription and have no systemic effects. Spermicides are also
important contributors to the efficacy of the contraceptive
sponge, diaphragm, and cervical caps.
The use of a spermicide alone provides less effective contraception than using it in combination with a barrier method.1
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contraindication to its use. Spermicides should not be used in
the presence of any condition that prohibits proper placement
high in the vagina over the cervix. Such genital tract abnormalities as a vaginal septum or double cervix will make the
correct placement of spermicide difficult, and are potential
contraindications to its use. Women who are uncomfortable
touching their genital area will likely be uncomfortable using
spermicides. If there is a personal or medical need for highly
effective contraception, spermicides should not be the first
contraceptive choice. Spermicides with nonoxynol-9 should
also not be recommended to sex workers or to women with
an increased risk of human immunodeficiency virus (HIV)
infection.4-6
Spermicides are available as film, jelly, suppository, cream, tablet,
and as a foam.
The Vaginal Contraceptive Film (VCF) is a 2-by-2 in. sheet
of film containing 28% nonoxynol-9. It must be inserted at
least 15 minutes before intercourse in order to melt and disperse. If more than one hour has elapsed before intercourse,
another film must be inserted. Inserting the film correctly
requires practice. Women who are accustomed to douche after
intercourse must be advised not to do so for at least 6 hours after
intercourse.1
Advantage 24 is a bioadhesive jelly that adheres to the cervix
and vagina, slowly releasing nonoxynol-9. It can be inserted up
to 24 hours before intercourse, but a repeat application is required
prior to each additional act of intercourse. Each application comes
separately packaged in inserters that resemble tampon inserters.1
Spermicidal foam is effective immediately and for up to one
hour after insertion. This preparation contains 12.5% nonoxynol-9.
It is inserted in the vagina using a supplied applicator. A repeat
application is required prior to each additional act of intercourse.
Spermicidal jellies (e.g., Orthogynol ll, K-Y Plus, Sure-seal
Gel) are intended for use with a diaphragm.
The Encare suppository, containing nonoxynol-9, must be
inserted 10 to 15 minutes prior to intercourse.
NON-CONTRACEPTIVE BENEFITS
The foams, creams, and jellies may be used as lubricants with
condoms.
RISKS AND SIDE EFFECTS
Genital irritation could lead to easier transmission of HIV.4-7
The use of spermicides has also been associated with an
increased risk of urinary tract infection.8
EFFICACY
MYTHS AND MISCONCEPTIONS
Studies are difficult to compare and vary widely in size,
focus, and quality.2 Failure rates in the first year of use vary
from 26% with typical use to 6% with perfect use.3
1. Use of a spermicide alone provides contraception that is as
reliable as the use of a barrier method.
Fact: Spermicides used alone have a substantially higher failure rate than other contraceptive methods.3,9
2. Nonoxynol-9 lubricated condoms are more effective than
regular condoms.
Fact: Condoms lubricated with or without N-9 are similarly effective in preventing pregnancy.10
3. Spermicides are effective microbicides.
Fact: Nonoxynol-9 is not an effective microbicide; in fact,
its use may increase the risk of sexually transmitted infection (STI) or infection with HIV.4-7,11 Spermicides appear
to have no protective effect against chlamydial and gonorrheal infections.7
Most of the clinical evidence on the risk of HIV infection
with use of N-9 comes from studies conducted among women
who were either sex workers or attending STI clinics. It is not
known whether these results also apply to situations in which
the dosage or frequency of N-9 use is lower.4-6
In keeping with the World Health Organization’s statements,10 it is recommended that:
• nonoxynol-9 not be used for the purpose of preventing
STI or HIV infection. Condoms should always be used
to prevent infection.
• although nonoxynol-9 has been shown to increase the risk
MECHANISM OF ACTION
Spermicides are composed of a spermicidal agent in a carrier that allows dispersal and retention of the agent in the vagina. Spermicides are surfactants that destroy the sperm cell
membrane by altering the lipid layer; the spermatozoon thus
becomes permeable and swells, with breakage of plasma and
acrosomal membranes.
INDICATIONS
The use of spermicides is only recommended as an adjunct
with other methods of contraception. Spermicide can be
used alone when fertility is naturally reduced. Spermicides
are also used as a backup contraceptive with the use of condoms, the diaphragm, and the cervical cap; it is also used as
a backup method in lactating women.
CONTRAINDICATIONS
An allergy to a spermicide or its carrier is the only absolute
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of HIV infection when used frequently by women at high
risk of infection, it remains a contraceptive option for
women at low risk.
• since high-frequency use of nonoxynol-9 products may
cause epithelial damage and increase the risk of HIV
infection, women who have multiple daily acts of intercourse should be advised to choose another method of
contraception.
• condoms lubricated with nonoxynol-9 are no more effective in preventing pregnancy or infection than are condoms lubricated with other products. Since adverse effects
due to the addition of nonoxynol-9 to condoms cannot
be excluded, such condoms should no longer be promoted. However, it is better to use a nonoxynol-9 lubricated condom than no condom at all.
• nonoxynol-9 should not be used rectally.
SUMMARY STATEMENTS
Instructions should be read and followed carefully, especially the
length of time from insertion of the spermicide to intercourse,
and the duration of effectiveness. (See Table 8.) Fertility awareness will increase the likelihood that another barrier method of
contraception will be added to the spermicide at the fertile time
of the cycle, thus enhancing efficacy. However, use of a spermicide may interfere with the assessment of cervical mucus.
Spermicide users should be counselled about the use of
emergency contraception in the event that they fail to use the
spermicide correctly.
1. Latex condoms, used consistently and correctly, will provide
protection against pregnancy (Level II-2) and STIs, including HIV infection (Level II-1). However, no barrier contraceptive method can provide 100% protection from all STIs.
2. Polyurethane and other non-latex condoms have an
increased incidence of breakage and slippage compared to
latex condoms; hence, the protection they provide against
STIs and HIV infection is inferior to that of latex condoms
(Level I). Polyurethane condoms remain important options
for reducing the risk of STIs in the presence of latex allergies. Lambskin condoms do not protect against HIV
infection.
3. The use of spermicide-coated condoms is associated with an
increased incidence of urinary tract infections. (Level II-1)
4. The effectiveness of barrier methods will be complemented
by the use of emergency contraception and fertility awareness. (Level III)
5. Condoms lubricated with nonoxynol-9 are no more effective in reducing the risk of pregnancy or infection than condoms lubricated with other products. (Level III)
6. Spermicides used alone are not a highly effective contraceptive method, although their efficacy may be enhanced when
used in combination with another contraceptive method.
(Level II-2)
7. The frequent use of nonoxynol-9 products may cause vaginal epithelial damage and may increase the risk of HIV infection. (Level 1)
TROUBLESHOOTING
RECOMMENDATIONS
INITIATION
1. Health-care providers should promote the consistent and
correct use of latex condoms to protect against pregnancy,
human immunodeficiency virus (HIV) infection, and
other STIs. Health-care providers should provide men
and women with information on the male and female
condom. (Grade A)
2. Women who use barrier methods of contraception
should be provided with emergency contraception and
relevant counselling. (Grade B)
3. Health-care providers should educate women and men
about the correct use of barrier methods. They should
emphasize the need for dual protection against pregnancy and infections. (Grade B)
4. The use of spermicide-coated condoms should no longer
be promoted. Nevertheless, the use of a nonoxynol-9
lubricated condom is preferable to the use of no condom
at all. (Grade C)
5. Health-care providers should be encouraged to be
familiar with the technique of fitting a diaphragm.
Diaphragms and cervical caps should continue to be
available in Canada. (Grade C)
Inserting a spermicide should be practised before coitus takes
place, in order to increase comfort with use. If genital irritation develops, steps must be taken to rule out an STI, vaginal
moniliasis, and bacterial vaginosis. If there is an unpleasant
genital odour, cultures should be taken and any specific
infection treated.
If “messiness” is a problem, spermicidal film or bioadhesive
jelly should be recommended.
If lack of spontaneity is an issue, bioadhesive jelly can be
inserted up to 24 hours before intercourse.
Table 8. How to Use Spermicides
•
•
•
•
•
Read and follow the package instructions.
Insert spermicide high in the vagina to cover the cervix.
Use the appropriate amount of spermicide.
Wait the recommended time between insertion and intercourse.
Insert an additional application of spermicide with every act of
intercourse.
• Do not douche for at least 6 hours after intercourse.
• Always have additional supply of spermicides.
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coitus in order to reduce or eliminate the potential for conception to occur. This understanding is also used to maximize
the potential for conception in couples who wish to conceive.
Natural family planning methods include fertility awareness,
coitus interruptus (withdrawal), and abstinence.
6. Nonoxynol-9 should not be used to reduce the risk of
STIs and HIV infection. Condoms should always be used
to reduce the risk of infections. (Grade A)
7. Since frequent use of nonoxynol-9 products may cause
epithelial damage and increase the risk of HIV infection,
health-care providers should advise women who have
multiple daily acts of intercourse to avoid using
nonoxynol-9 products. (Grade A)
1. FERTILITY AWARENESS
INTRODUCTION
REFERENCES
Some natural family planning methods use fertility awareness
as their basis. Fertility awareness methods identify the woman’s
fertile period and thereby the days on which intercourse should
be avoided or carefully protected with barrier methods. Couples can use this information to guide their efforts to avoid or
achieve pregnancy.1,2
The 3 primary fertility signs are changes in cervical mucus,
basal body temperature (BBT), and cervical position. In addition to methods that observe biological signs of fertility, some
methods rely only on calculations using the calendar.
1. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al,
editors. Contraceptive technology. 17th ed. New York, NY: Ardent
Media; 1998. p. 216–7.
2. Family Health International. How effective are spermicides? Network
2000:20(2). Available on-line at: <http://www.fhi.org/en/RH/Pubs
/Network/v20_2/NWvol20-2spermicids.htm> Web site updated 2003.
Accessed January 29, 2004.
3. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
4. Hoffman T,Taha TE, Martinson F. Adverse health event occurring during
an n-9 gel pilot study: Malawi. 13th International AIDS Conference; July
9–14, 2000; Durban, South Africa. Abstract No.TuPpC1171.
5. VanDamme L, Ramjee G, Alary M,Vuylsteke B, Chandeying V, Rees H,
et al. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1
transmission in female sex workers: a randomized controlled trial.
Lancet 2002;360:971–7.
6. Wilkinson D, Ramjee G,Tholandi M, Rutherford G. Nonoxynol-9 for
preventing vaginal acquisition of sexually transmitted infections by
women from men. (Cochrane Review). Oxford: Update Software.
Cochrane Database Syst Rev 2002;(4): CD003939.
7. Roddy RE, Zekeng L, Ryan KA,Tamoufem U,Weir SS,Wong EL. A controlled trial of nonoxynol 9 film to reduce male-to-female transmission
of sexually transmitted diseases. New Engl J Med 1998;339:504–10.
8. Hooton TM, Scholes D, Hughes JP, Winter C, Roberts PL, Stapleton AL,
et al. A prospective study of risk factors for symptomatic urinary tract
infection in young women. New Engl J Med 1996;335:468–74.
9. Sangi-Haghpeykar H, Poindexter AN III, Levine H. Sperm transport and
survival post-application of a new spermicide contraceptive. Advantage
24 Study Group. Contraception 1996;53:353–6.
10. World Health Organization.Technical consultation on nonoxynol-9:
meeting report. Geneva:WHO; October 9–10, 2001. Available
on-line at <http://www.who.int/reproductive-health/rtis/N9_meeting
_report.pdf>.Web site updated June 25, 2002. Accessed January 29,
2004.
11. Health Canada. Centre for Infectious Disease Prevention and Control.
Nonoxynol-9 and the risk of HIV transmission. HIV/AIDS Epi Update.
Ottawa: Health Canada; April 2002. Available on-line at <http://www
.hc-sc.gc.ca/pphb-dgspsp/publicat/epiu-aepi/hiv-vih/nonoxynol_e.html>.
Web site updated May 7, 2003. Accessed January 29, 2004.
EFFICACY
The effectiveness of NFP methods is difficult to calculate. Most
published studies are flawed in design and calculate pregnancy
rates incorrectly. Reports of effectiveness do not usually include
data on methods of teaching, content of teaching, time spent
teaching, and whether one or both partners were taught.1 The
World Health Organization cites a failure rate of 20% for common use and 1% to 9% for perfect use.3
MECHANISM OF ACTION
FERTILITY AWARENESS AND THE SYMPTOTHERMAL
METHOD
This method uses all 3 fertility signs.
CERVICAL MUCUS
The woman is taught to monitor the volume and changes in
quality of cervical mucus before ovulation. The mucus becomes
clearer and more elastic (described as showing spinnbarkeit) as
ovulation approaches. After ovulation, the mucus becomes viscid, opaque, and impenetrable to sperm, and mucus volume
reduces abruptly. Three days after “peak” (clearest and most elastic) mucus, the woman enters the less fertile phase. Although
there may be a first infertile phase starting with the first day of
menses, it varies in length depending on the rapidity of the ovarian follicular response. If the follicular response is very rapid,
there may be mucus present during menstruation. Although
the timing of ovulation may be unpredictable, observing cervical mucus changes can alert women to its approach.
CHAPTER 9: NATURAL FAMILY PLANNING METHODS
Ruth Miller, MEd,1 Louise Hanvey, BN, MHA2
1Toronto
2Chelsea
ON
QC
Natural family planning (NFP) refers to methods of controlling
fertility that do not involve the use of contraceptive devices or
chemicals. It relies on an understanding of the physiology of the
menstrual cycle and on the timing of ovulation to schedule
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BASAL BODY TEMPERATURE
Body temperature is measured orally or vaginally, using a special BBT thermometer, after at least 6 hours of sleep. Following the post-ovulatory elevation of progesterone, basal
temperature should rise in the luteal phase of the cycle by at
least 0.5ºC. Given that this temperature rise follows ovulation,
it indicates that the fertile period has ended. However, for
women who wish to conceive, it may reveal a pattern of ovulation for future cycles. To avoid pregnancy, unprotected intercourse should be delayed until after 3 consecutive days of
temperature elevation.
16 days before the onset of the next menses, that sperm
remain viable for up to 5 days, and that the oocyte survives
unfertilized for 24 hours. Based on this method, a couple
would avoid intercourse or use another contraceptive method
during an 8- to 10-day period in each cycle. The woman must
chart a menstrual calendar over several months. Her fertile
period is determined by subtracting 20 days from the length
of her shortest cycle (to establish when the fertile period
begins) and subtracting 10 days from the length of her longest
cycle (to establish when the fertile period ends.) This method
is not recommended as a sole method of contraception.
CERVICAL POSITION
Women are taught to detect the changes in the position of the
cervix and in the size of the cervical os. The cervix can be felt
close to the introitus post-menstrually, and its position rises
appreciably within the vagina during the follicular phase. It
reaches its highest point at ovulation. The consistency of the
cervix becomes soft and the os more open. During the luteal
phase it descends within the vagina and becomes firm, closed,
and closer to the introitus. This sign is the most difficult to assess
for most women.
OVULATION PREDICTOR KITS
Most research on ovulation prediction and detection devices
has focused on helping women who wish to conceive. Most
ovulation-predictor home test kits detect a specific level of
luteinizing hormone (LH) in urine or saliva which will be present on the day before or the day of ovulation. Women seeking
to conceive can time intercourse to coincide with these days (or
earlier in the fertile time if she is using a fertility awareness-based
method). Two fertility indicator kits available in Canada monitor saliva patterns which correlate with serum estradiol levels
and ovarian follicular activity. All of these products are marketed as aids for women to determine the best time for conception
— not for contraception.7,8
A new test kit has been developed to help women avoid
pregnancy. The test uses a small hand-held electronic monitor
and disposable urine test sticks. The monitor measures a
urinary metabolite of estrogen and LH.9,10 An independent
prospective study showed a method failure rate of 6.2%,11,12
although others consider it to be higher.13 It is available in some
countries in Europe.
BILLINGS OVULATION METHOD
The Billings method relies on cervical mucus changes only, as
described above. It is used primarily by couples for whom the
teachings of the Roman Catholic Church allow no recourse to
barrier methods. In those for whom pregnancy would be undesired, reliance on the second infertile phase only (post-ovulation) is advised.4
TWO-DAY ALGORITHM
This is a simple method for identifying the fertile window. It
classifies a day as “fertile” if the cervical secretions are present
on that day or were present on the previous day. This method
may be useful in populations where other NFP methods are difficult to implement due to lack of trained NFP teachers or to
the cost and availability of BBT thermometers.5
LACTATIONAL AMENORRHEA METHOD
The lactational amenorrhea method (LAM) of contraception
is highly effective as a temporary postpartum method in
a variety of cultures, health-care settings, socio-economic
strata, and in both industrial and developing country locales.14
The method is based on the physiological infertility of
breastfeeding women caused by hormonal suppression of
ovulation.
This method is 98% effective for a breastfeeding woman if
1. her menses have not returned and
2. she is fully or nearly fully breastfeeding (i.e., the only additional intake is infrequent water, juice, or vitamins); and
3. her baby is under 6 months of age.
Intervals between breastfeedings should not exceed 4 hours
during the day and 6 hours at night.15 Since the pregnancy rate
increases in women whose infants are receiving supplementary food,16 despite continued lactational amenorrhea, a
supplementary contraceptive method should be used by these
women if they wish to avoid conception.
STANDARD DAY METHOD
This method defines menstrual cycle days 8 to 19 as the fertile
window.6 During this time the couple abstains from intercourse.
This method is only useful for women with cycles ranging from
26 to 32 days in length. It requires a long period of abstinence
but can be combined with a barrier method. It is not as reliable
as methods that chart fertility signs, as it does not account for
circumstances that would affect the timing of ovulation such as
stress or illness.
CALENDAR METHOD
Women must calculate the onset and duration of their fertile
period based on the assumptions that ovulation occurs 12 to
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INDICATIONS
INITIATION
Natural family planning may be a contraceptive option for
• couples who wish to avoid using barrier or hormonal
methods of contraception
• couples who wish to increase the effectiveness of barrier
methods or withdrawal during the fertile phase
• couples for whom an accidental pregnancy would be
acceptable
Please note: One additional indication for LAM is being postpartum which is a contra-indication for the other natural family planning methods.
Instruction in NFP is recommended, although women can learn
this method from a number of reference books — the most comprehensive of which is Taking Charge of Your Fertility.18 Courses
may be given in the community, although potential users should
be aware that some organizations teach natural family planning
within a religious context and do not condone the use of barrier
methods as an adjunct to this method (e.g., the Serena organization). This organization uses a couple-to-couple approach to teach
the Symptothermal method of NFP within a religious framework.
When fertility signs are difficult to assess (such as in the
presence of a vaginal discharge), either barrier contraceptives or
abstinence should be used. A woman who has intercourse within the fertile period could use emergency contraception.
The Billings ovulation method is taught by Billings certified instructors who work within the framework of the Roman
Catholic Church.
CONTRAINDICATIONS
Natural family planning may not be a suitable option for
• couples who are unwilling or unable to be diligent about
observing and charting the signs of fertility, and about
complying with the rules to prevent pregnancy
• women whose menstrual cycles are erratic
• women post-partum (except for LAM)
• women who have difficulty assessing cervical mucus
because of vaginal infection or use of vaginal agents
(e.g., lubricants, spermicides)
TROUBLESHOOTING
Couples who chose NFP should be counselled about emergency
contraception.
REFERENCES
NON-CONTRACEPTIVE BENEFITS
1. Lamprecht V,Trussell J. Natural family planning effectiveness: evaluating
published reports. Adv Contracept 1997;13:155–65.
2. Stanford JB,White GL, Hatasaka H.Timing intercourse to achieve
pregnancy: current evidence. Obstet Gynecol 2002;100:1333–41.
3. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
4. Guillebaud J. Contraception: your questions answered. 3rd ed.
Edinburgh: Churchill Livingstone; 1999. p. 23–37.
5. Dunson DB, Sinai I, Colombo B.The relationship between cervical
secretions and the daily probabilities of pregnancy: effectiveness of the
two-day algorithm. Hum Reprod 2001;16:2278–82.
6. Aravalo M, Sinai I, Jennings V. A fixed formula to define the fertile window of the menstrual cycle as the basis of a simple method of natural
family planning. Contraception 1999;60:357–60.
7. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al.,
editors. Contraceptive technology. 17th ed. New York: Ardent Media;
1998. p. 309–23.
8. Health Canada. Listing of medical devices licenses. Available on-line at
<http://www.pigscanfly.ca/~adouglas2/CMBES_Website_pages/daffodil
.hc-sc.gc.ca_8080/adouglas/CMBES_healthcanada_page.html>.Web site
updated September 25, 2003. Accessed February 10, 2004.
9. May K. Monitoring reproductive hormones to detect the fertile period:
development of Persona – the first home-use system. Adv Contracept
1997;13:139–41.
10. Pyper CM, Knight J. Fertility awareness methods of family planning: the
physiological background, methodology, and effectiveness of fertility
awareness methods. J Fam Plann Reprod Health Care 2001;27:103–9.
11. Bonnar J, Flynn A, Freundl G, Kirkman R, Royston R, Snowden R. Personal hormone monitoring for contraception. Br J Fam Plann 1999;24:
128–34.
12. Bonnar J, Freundl G, Kirkman R. Personal hormone monitoring for
contraception. Br J Fam Plann 2000;26:178–9.
Women who monitor or chart their fertility signs often have
greater awareness of their own gynaecological health and are
better able to discern the difference between normal and
abnormal cervical secretions. As well, charting fertility signs
can alert women to factors that may contribute to infertility,
such as anovulation.4 Incorporating this information into family planning programs generally would greatly benefit
women.17
RISKS AND SIDE EFFECTS
There is a high probability of failure with all fertility awareness methods if they are not used consistently and correctly.
Also, for the protection against STIs condoms need to be used
in addition to NFP.
MYTHS AND MISCONCEPTIONS
1. Most women know when they are fertile.
Fact: Numerous studies have shown that many women are not
well informed about when they are fertile during each month.17
2. NFP is unreliable.
Fact: These methods can be quite reliable when used
correctly. The World Health Organization cites a failure rate
of 20% for common use and 1% to 9% for perfect use.3
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transmitted infection (STI).
Women who need to avoid pregnancy should not rely on
this method alone.
13. Trussell J. Contraceptive efficacy of the personal hormone monitoring
system Persona. Br J Fam Plann 1999;24:134–5.
14. Labbok MH, Hight-Laukaran V, Peterson AE, Fletcher V, von Hertzen H,
Van Look PF. Multicenter study of the lactational amenorrhea method
(LAM): 1. efficacy, duration and implications for clinical application.
Contraception 1997;55(6):327–36.
15. Institute for Reproductive Health. Guidelines: breastfeeding, family
planning and the lactational amenorrhea method (LAM). Washington,
DC: Georgetown University, Department of Obstetrics and Gynecology
(2115 Wisconsin Avenue NW, 6th Fl., 20007); 1994. p. 3–5.
16. Kennedy KI,Visness CM. Contraceptive efficacy of lactational amenorrhoea. Lancet 1992;339:227–30.
17. Seidman M. Requirements for NFP service delivery: an overview.
Adv Contracept 1997;13:241–7.
18. Weschler T. Taking charge of your fertility: the definitive guide to
natural birth control, pregnancy achievement, and reproductive health.
Revised ed. New York: Quill, Harper Collins; 2002.
NON-CONTRACEPTIVE BENEFITS
There are no costs involved. Theoretically, withdrawal reduces the risk of male-to-female transfer of human immunodeficiency virus (HIV) because the virus is concentrated in
semen.5
RISKS AND SIDE EFFECTS
Use of withdrawal requires self-control. The man must have the
ability to recognize impending ejaculation and to resist the urge
to pursue coital movement.
Theoretically, the pre-ejaculate contains no spermatozoa.
One study has shown the presence of a small number of
clumped spermatozoa in the pre-ejaculate, presumably from a
prior ejaculation.5 In HIV-infected men, the pre-ejaculate may
contain HIV-infected cells.6 Other STIs may also be transferred,
if they are transmitted by mucosal or skin contact.
2. COITUS INTERRUPTUS (WITHDRAWAL)
INTRODUCTION
Coitus interruptus is probably more widely used for contraception than is acknowledged. Up to 9% of sexually active women in
Canada report using withdrawal as a method of contraception.1
Family planning professionals and survey respondents may not
regard coitus interruptus as a legitimate contraceptive method, and
may therefore fail either to ask about or to acknowledge its use. It
is widely used in both developed and developing countries.2
MYTHS AND MISCONCEPTIONS
It is difficult to accurately assess the effectiveness of this method
because data are lacking.3 Failure rates for the first year of using
withdrawal have been described as 4% with perfect use and
19% with typical use, although the estimate of failure with typical use is probably high.4
1. Withdrawal is not an effective method of contraception.
Fact: This method is widely used around the world and can
be effective if followed carefully.
2. The pre-ejaculate contains enough sperm to achieve a
pregnancy.
Fact: Although there have been few studies in this area, existing research suggests that the pre-ejaculate does not contain
sperm.6
MECHANISM OF ACTION
INITIATION
During coitus the male withdraws the penis from the vagina
prior to ejaculation.
Health care providers should make people aware that withdrawal
should not be used permanently. Other options of contraception
should be offered. The patient should know about all the risks
involved since the withdrawal requires considerable self-control.
EFFICACY
INDICATIONS
Withdrawal may be a contraceptive option when
• no other contraception is available
• the couple prefers to avoid hormonal, barrier, and permanent methods of contraception
• religious considerations preclude the use of other methods
• intercourse is infrequent
TROUBLESHOOTING
The couple should be counselled about emergency contraception, should there be inadvertent contact between the ejaculate
and the vagina or external genitalia.
REFERENCES
CONTRAINDICATIONS
1. Fisher W, Boroditsky R, Morris B.The 2002 Canadian contraception
study. J Obstet Gynaecol Can. In press 2004.
2. Gillebaud J. Contraception: your questions answered. 3rd ed. Edinburgh:
Churchill Livingstone; 1999. p. 39–43.
Since intromission occurs, this method of contraception
should not be used if there is a known risk of sexually
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3. Rogow D, Horowitz S.Withdrawal: a review of the literature and an
agenda for research. Stud Fam Plann 1995;26:140–53.
4. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
5. Pudney J, Oneta M, Mayer K, Seage G, Anderson D. Pre-ejaculatory fluid
as potential vector for sexual transmission of HIV-1. Lancet 1992;
340:1470.
6. Zukerman Z,Weiss DB, Orvieto R. Does pre-ejaculatory penile secretion originating from Cowper’s gland contain sperm? J Assist Reprod
Genet 2003;20(4):157–9.
deliberately choose to abstain at a number of times throughout
their lives.1
CONTRAINDICATIONS
Both partners in a relationship should choose this method to
avoid frustration on the part of one.
NON-CONTRACEPTIVE BENEFITS
Non-contraceptive benefits of abstinence include
• freedom from the threat of STI and HIV infection if there
is no exchange of body fluids
• no physical side effects
• no need to visit a health-care provider. However, healthcare providers can offer valuable support, information,
and alternative options should individuals wish to consult about this method
• no cost, unless condoms and dams are used
3. ABSTINENCE
INTRODUCTION
Abstinence is defined by some as refraining from all sexual
behaviour, including masturbation; by some as refraining from
sexual behaviour involving genital contact; and by others as
refraining from penetrative sexual practices.1
Giving and receiving sexual pleasure without penetration is
an important part of sexual expression for both men and
women and is effective in decreasing the risk of sexually transmitted infection (STI) and pregnancy.
RISKS AND SIDE EFFECTS
Risks and side effects include concern that abstinence
• may be too restrictive for some couples
• does not encourage the use of other methods of contraception, if behaviour patterns change
EFFICACY
If the goal of abstinence is to avoid unwanted pregnancy, this
method is very effective and allows people to be involved in
other forms of sexual expression without increasing the risk of
pregnancy. However, if the goal is to avoid STIs, then oralgenital sex, anal-genital sex, and other activities that expose the
partner to pre-ejaculatory fluid, semen, cervical-vaginal secretions, or blood must be avoided.
Although very few cases of human immunodeficiency
virus (HIV) transmission have been reported if the only transmission of fluid has been during oral sex,2,3 it is possible to
transmit gonorrhea, syphilis, hepatitis B, herpes simplex virus,
and chlamydia by mouth-to-penis contact (fellatio).4 Mouthto-vulva contact (cunnilingus) can transmit herpes and
syphilis.4,5
MYTHS AND MISCONCEPTIONS
1. “Just say no,” or abstinence-only education, is an effective
approach to sex education for young people.
Fact: No abstinence-only sex education program has been
shown to increase the likelihood that young people will delay
first intercourse for any longer than those who do not receive
such programs.6 This is in contrast to the results of “abstinence-plus” programs that strongly encourage youth to be
abstinent but also encourage youth to use condoms and contraceptives if they do have intercourse; these programs have
been found to delay first intercourse for an appreciable time
period.6 Many studies with very strong research designs have
demonstrated that programs with common characteristics,
(such as that they clearly focus on reducing specific sexual
risk-taking behaviours, provide directly relevant information, give students the opportunity to develop the motivation and personal insight to use the information, and help
them develop the necessary behavioural skills), can delay sexual intercourse, reduce its frequency, and increase use of condoms and other contraceptives.7,8
2. Once people have had sexual intercourse, they will not willingly choose abstinence.
Fact: Once young men and women have satisfied their initial
curiosity about intercourse, and once they feel socially
ADDITIONAL DEVICES
The use of a dry latex condom during fellatio or a dam during
cunnilingus can be effective. Spermicidal condoms are not recommended, since they are unlikely to provide better protection,
and the taste is very often unpleasant.
INDICATIONS
Primary abstinence (i.e., abstaining from some or all sexual
behaviour by a person who has not yet been sexually active) is
not uncommon among young people. Indeed, people of all ages
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comfortable with their level of sexual sophistication, they may
decide to become abstinent, removing themselves at least temporarily from the health risks of intercourse. Health-care
providers can help young people learn that the door between
abstinence and sexual activity opens in both directions.1
RECOMMENDATIONS
1. Health-care providers should respect the choice of a natural family planning method and be able to provide
resources to support the correct use of this method.
(Grade C)
2. The use of coitus interruptus (“withdrawal”) should be
recognized as a risk-reduction strategy. When couples use
coitus interruptus or other natural family planning
methods, health-care providers should provide information about emergency contraception. (Grade C)
3. Health-care providers should acknowledge and legitimize
abstinence as a valid contraceptive choice. (Grade B)
4. Comprehensive sex education should be available to all
Canadians. Education programs should provide information on abstinence as well as on contraception and
STI prevention. (Grade B)
5. Health-care providers should be able to counsel postpartum women about the contraceptive efficacy and correct
use of the lactational amenorrhea method. (Grade A)
INITIATION
Asking individuals what they define as abstinence is an important question with clinical implications.
Couples and individuals practising abstinence deserve
respect, encouragement, and non-judgemental support. They
should be offered education about other methods of birth control and safer sex to help them if their sexual agenda changes.
Assisting with communication skills to transmit intentions to
partners can be valuable, especially for young people. Those
who practise abstinence should be informed about emergency
contraception and its availability in their community.
TROUBLESHOOTING
REFERENCES
Health-care providers should determine with those choosing
abstinence why they made this choice, what sexual activities
they will say “yes” to, and whether they have discussed these
with their partner. It is important to help them avoid high-pressure sexual situations and teach them techniques for saying “no.”
It is also important to suggest that condoms be readily available in case they change their minds; in addition, they must be
aware of options for emergency contraception.
1. Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al.,
editors. Contraceptive technology. 17th ed. New York: Ardent Media;
1998. p. 297.
2. Bratt GA, Berglund T, Glantzberg BL, Albert J, Sandstrom E.Two cases
of oral-to-genital HIV-1 transmission. Intl J STD AIDS 1997;8:522–5.
3. Robinson ED, Evans BG. Oral sex and HIV transmission. AIDS 1999;
16(6):737–8.
4. Edwards S, Carne C. Oral sex and transmission of non-viral STIs. Sex
Transm Infect 1998;74(2):95–100.
5. Ostergaard L, Agner T, Krarup E, Johansen UB,Weismann K, Gutschik E.
PCR for detection of Chlamydia trachomatis in endocervical, urethral,
rectal, and pharyngeal swab samples obtained from patients attending
an STD clinic. Genitourin Med 1997;73(6):493–7.
6. McKay A. Common questions about sexual health education. SIECCAN
(Sexuality Information and Education Centre Canada) Newsletter,
Summer 2000;35:1.
7. Kirby D. Do abstinence-only programs delay the initiation of sex among
young people and reduce teen pregnancy? Washington, DC: National
Campaign to Prevent Teen Pregnancy; 2002.
8. Fisher WA, Fisher JD. Understanding and promoting sexual and reproductive health behaviour: theory and method. Annu Rev Sex Res
1998;9: 39–76.
SUMMARY STATEMENTS
1. Natural family planning methods may provide effective contraception when used diligently and selectively. (Level II-2)
These methods may be appropriate methods of contraception for couples who are willing to accept a potentially
higher rate of contraceptive failure. (Level III)
2. Fertility awareness may be used in combination with nonhormonal methods of contraception to enhance the effectiveness of these other methods. (Level III)
3. Coitus interruptus (“withdrawal”) is preferable to no contraception at all, but failure rates may be high and it does not
provide protection against STIs. (Level II-2)
4. The lactational amenorrhea method is an effective method
of contraception for the first 6 months postpartum in
women who are exclusively breastfeeding and have not yet
resumed menstrual cycling. (Level II-2)
5. Abstinence is a valid contraceptive choice. Although programs have been introduced to promote abstinence among
young people, there is no evidence that abstinence-only programs are successful in delaying first intercourse among adolescents. (Level I)
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CHAPTER 10: STERILIZATION
Claude A. Fortin, MD, FRCSC,1 Edith Guilbert, MD, MSc2
1Montreal
2Quebec
QC
City QC
INTRODUCTION
It is important that individuals who consult for sterilization
want no more children, or want to remain childless, and they
need a highly effective contraceptive method. To make an
informed decision, these individuals should have an accurate
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understanding of sterilization and should consider their own
needs and those of their family. The decision should be made
without pressure or coercion from anyone else.1
laparoscopically are the application of tubal clips or rings, or
electrocautery of a portion of tube.
Interval sterilizations may also be performed via a small
(“mini”) laparotomy incision, or they may be performed at
the time of a laparotomy done for an unrelated indication.
With a laparotomy approach, any of the laparoscopic techniques for occlusion may be used; more commonly, an intervening segment of tube is excised and the ends ligated (the
Pomeroy method). The vaginal colpotomy approach to interval tubal ligation has now been largely abandoned because of
increased risks of infection and post-sterilization failure and
dyspareunia.7
The frequency of concurrent sterilization and abortion is
unknown, but effective counselling is mandatory and has to be
provided with expertise.8
Post-partum sterilization must also be performed after careful counselling. Post-partum sterilization should be performed
either within 7 days of delivery or postponed until at least 4
weeks after delivery.9 Usually a tubal excision method will be
used rather than an occlusive method. Tubal ligation may also
be performed by an excisional technique at the time of Caesarean section. If partial salpingectomy is performed, the
superior long-term success appears to be higher.2
1.TUBAL LIGATION
EFFICACY
Although in theory tubal ligation will prevent pregnancy
absolutely, conceptions do occur. Failure of tubal ligation continues to occur well beyond the first year after surgery, and at
10 years post-surgery, the overall figure rises to 1.8%.2 In one
Canadian province, the failure rate of tubal ligation at 20
years was 0.9%.3
The 10- and 20-year cumulative probabilities of failure are
affected by age at tubal ligation. The probability of failure for
women sterilized at age 28 or less is greater than for women sterilized beyond age 34, for all methods of sterilization except for
interval partial salpingectomy.2,3 Tubal ligation performed vaginally may be technically difficult, and may therefore carry a
higher chance of failure. A New Zealand review4 described a
failure rate after vaginal tubal ligation of 4.8%, compared with
a rate of 1.2% after Filshie clip application, 1.4% after application of Falope rings, and 3.4% after application of Hulka clips.
Two randomized controlled trials comparing use of Hulka and
Filshie clips for sterilization showed 24-month cumulative pregnancy rates of 28.1/1000 women and 9.7/1000 women, respectively — although this difference was not statistically
significant.5 The World Health Organization cites a failure rate
after tubal ligation of 0.5%.6
TRANSCERVICAL STERILIZATION
As of 2002, a new transcervical approach for tubal occlusion
has gained popularity and received acceptance by the Canadian Therapeutic Products Directorate and the U.S. Food and
Drug Administration.10 It is a method of sterilization that
involves accessing the tubes through hysteroscopic or blind
placement of a device or occlusive material that blocks the
tubes.
The procedure offers numerous potential advantages over
other sterilization methods: no incision is required; it is performed under local anaesthesia or minimal sedation, in an office
setting with a rapid recovery; and it has been shown to be highly reliable and cost-effective.11 However, health professionals
need special training to perform this technique, and women
must use another method of birth control for at least 3 months
before the technique is felt to be fully reliable.
The only device available for clinical use in Canada is the
Essure System. The device consists of an expandable outer nitinol coil, containing polyester fibres and a stainless steel inner
coil that dynamically expands into the proximal portion of the
fallopian tube. Over a 3 month period, tissue grows over the
device to occlude the tubes completely. In women in whom
both tubes were accessible and the devices properly placed, no
pregnancies and a low complication rate have been reported.11
Other transcervical approaches are currently under different phases of trials or animal studies. These include the Adiana
system, the Intratubal Ligation Device, and the use of
MECHANISM OF ACTION
Tubal ligation techniques result in the occlusion of the fallopian tubes, preventing the ovum and spermatozoa from meeting.
The choice of occlusion method depends upon the surgeon’s training, personal experience, and the technical facilities.
It will also depend on whether the sterilization is performed
remote from a pregnancy (interval sterilization), or post-abortion, or post-partum.
Interval sterilizations are most commonly performed via
laparoscopy. The techniques used for tubal ligation performed
Table 1. 10-Year Failure Rates (Crest Study)2
Method
Rate (%)
Bipolar tubal coagulation
Unipolar tubal coagulation
Silicone ring
Spring clip (Hulka)
Interval partial salpingectomy
Postpartum partial salpingectomy
2.48 (1.63–3.33)
0.75 (0.11–1.39)
1.77 (1.01–2.53)
3.65 (2.53–4.77)
2.01 (0.47–3.56)
0.75 (0.27–1.23)
All methods
1.85 (1.51–2.18)
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quinacrine pellets or erythromycin tablets for tubal occlusion.12
Effects of the presence of any of these devices on the success of
subsequent in vitro fertilization are unknown.
lihood of expressing regret, requesting information about reversal of sterilization, and obtaining reversal, increase over the years
following sterilization.3,18-21 During a follow-up interview within 14 years of tubal sterilization, 20.3% of women who have
been sterilized before age 30 expressed regret about undergoing
the procedure, compared to 5.9% of those sterilized after age
30.18 The probability of reversal in one Canadian province, over
20 years, was respectively 4.2% and 3.9% for women and men
who were sterilized before age 30, and 0.4% and 1.0% for those
sterilized in their late 30s.3 Other known risk factors for regret
and reversal are having young children; experiencing couple
disharmony; and being sterilized at the time of Caesarean section or shortly after delivery, spontaneous or induced abortion.3,18-24 Common reasons given for requesting reversal are:
“did not receive enough information,” “was pushed into this
procedure,” sexual side effects from sterilization, the establishment of a new relationship, improvement in housing or financial circumstances, or the loss of a child.22-24
INDICATION
Assessing the needs of individuals who consult for a sterilization procedure is crucial, because the procedure should be
considered permanent. Reversal of sterilization, although feasible, is difficult to obtain, involves riskier surgery than sterilization itself, is expensive, and often does not succeed in
restoring fertility.13,14 There are contraceptive methods other
than sterilization that are easily available to both men and
women, and the sterilization procedure may have unwanted
side effects.
Health care providers should be aware of the legal requirements for obtaining informed consent for sterilization, including an explanation of benefits and risks, options, and
determination of whether the person is competent to understand the information.15 When the person has a mental disability, it is even more difficult for the physician to determine
their capacity to provide informed consent.16 Contraceptive
sterilization of an incompetent, mentally disabled person is
illegal.17
NON-CONTRACEPTIVE BENEFITS
Tubal ligation, although somewhat invasive, provides women
with a very private and cost-effective method of contraception,
with no significant long-term side effects, no compliance issues,
and no interference with intercourse.
SPECIAL CONSIDERATION
WITH THE TRANSCERVICAL PROCEDURE
SIDE EFFECTS
Since reversibility of this procedure is virtually impossible,
appropriate counselling is extremely important. Women with
uterine or tubal disease, who are ambivalent about sterilization,
or who feel uncomfortable about having a device or materials
inserted into their fallopian tubes should not be offered this
technique. Women who have a contraindication to laparoscopic
sterilization (obese or severe medical conditions), and who are
over age 30 with no uterine or tubal anomaly, might be eligible
for transcervical sterilization. Long-term efficacy and potential
hidden side effects are not known for this method.
The following are possible short-term side effects from tubal
ligation:
• shoulder tip pain secondary to usage and remaining of
some gas (CO2) inside the peritoneal cavity
• lower abdominal pain or cramps
• bruising, bleeding from incisions
• post-operative nausea and light-headedness
RISKS
SHORT-TERM COMPLICATIONS
The incidence of complications depends on the procedure performed (laparoscopy or laparotomy, mechanical or thermal),
the anaesthesia used (local or general), and the experience of the
surgeon.2
Potential complications include the following:
• anaesthesia-related risks
• wound infection
• bruising
• hematoma formation
• urinary complications
• mesosalpingeal tears and trans-section of the tube from
ring or clip application (may require laparotomy to control bleeding)
CONTRAINDICATIONS
The following are considered contraindications to performing
tubal ligation:
1. systemic health problems, especially cardiopulmonary conditions that may be aggravated by general anaesthesia
2. pregnancy (unless the sterilization procedure is done at the
time of abortion or immediately postpartum)
3. the presence of pelvic infection, or inability to access the fallopian tubes at surgery
4. uncertainty about whether permanent contraception is
desired
The major concern with sterilization is regret. The cumulative likeJOGC
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Fact: A single study found an increased risk of hysterectomy
in women who underwent sterilization between the ages of
20 and 29, but not among women sterilized over the age of
30.33 No biological basis for these results has been found.33,34
• mechanical trauma, including uterine perforation with
uterine elevator
• injury to blood vessels, intestines or other organs (incidence approximately 0.6 per 1000 cases).25 Bowel burns
complicating tubal electrocoagulation may result in
delayed perforation and peritonitis.
INITIATION
Taking a medical and a contraceptive history is essential. Key
elements in the medical history are the patient’s age, marital status, spouse’s age, type of relationship, number and age of children, contraceptive experience, reasons for sterilization, and
systemic health problems. The medical history will emphasize
any history of pelvic disease, previous abdominal or pelvic
surgery, heart or lung disease, bleeding problems, allergies, medication, and previous problems with general anaesthesia.
A complete physical examination must be performed shortly before sterilization.
Laboratory evaluation may be limited to measurement of
haemoglobin level. Effective contraception must be used until
the time of the tubal ligation.
Since post-sterilization regret is common, careful pre-surgery
counselling with awareness of risk factors is essential. Information about the type of operation — including risks and benefits,
the availability of alternative methods of family planning, the
possibility of failure, and the possibility of reversal — must all
be discussed so that the individual can provide informed consent for surgical sterilization. A consent document, readily understandable in the individual’s own language, must be signed. It is
recommended that the sterilization be performed a few weeks
after the initial interview, to allow more consideration of the
choice of sterilization. Written information may be useful.
POTENTIAL RISKS WITH USE OF THE
TRANSCERVICAL PROCEDURE
Some risks that are possible with the transcervical procedure
include the following:
• perforation or dissection of fallopian tube or uterine cornu
• uterine perforation by the hysteroscope
• placement of micro-insert into the myometrium or into
the distal tube
• subsequent procedures such as electrocautery, endometrial biopsy, dilatation and curettage, or endometrial ablation potentially could dislodge a micro-insert or interrupt
its ability to prevent pregnancy11
LONG-TERM COMPLICATIONS
ECTOPIC PREGNANCY
Ectopic pregnancy should be ruled out whenever a woman
shows signs of pregnancy following tubal occlusion. The
CREST study demonstrated a 10-year cumulative probability
of ectopic pregnancy of 7.3 per 1000 women for all methods
combined.2 A report from Korea of ectopic pregnancies following sterilization showed an approximately 3-fold greater incidence of ectopic pregnancies after electro-coagulation than after
the use of silastic rings or clips.26 Ectopic pregnancy was most
often related to the following: utero-peritoneal fistula after
unipolar electro-coagulation; inadequate coagulation or recanalization after bipolar procedures; recanalization or fistula formation after Pomeroy, tubal ring, or clip procedures.27
TROUBLESHOOTING
REVERSAL
Reversal of tubal ligation requires major surgery and special surgical skills. Some women are not appropriate candidates because
of the way the sterilization was performed. Success cannot be
guaranteed and reversal surgery is usually expensive. There are
operative risks due to anaesthesia and the usual risks of major
abdominal surgery. The risk of ectopic pregnancy is about 5%
following reversal surgery and depends on the type of tubal ligation.2 Pre-reversal assessment includes exclusion of male possible infertility factors, female ovulation disorders and laparoscopic assessment of the tubal segments.
Rates of subsequent term delivery vary, but they are highest after reversal of occlusion techniques that damage a small
segment of the tube (such as with a tubal clip or ring) and lowest after electrocoagulation. (See Table 2.) The occurrence of
ectopic pregnancy after reversal surgery may be due to pre-existing abnormal tubal function, or to factors arising from the surgical technique used. In vitro fertilization (IVF) may be an
MENSTRUAL PATTERN CHANGES
Abnormal menstrual patterns have been thought to occur following sterilization, and a “post-tubal ligation syndrome” has
been proposed. There is no supportive evidence.28-31
A recent review of the literature comparing sterilized and
control women found no difference in hormones levels and little difference in menstrual cycle characteristics.32
PSYCHOSEXUAL PROBLEMS
No evidence of psychological problems or detrimental longterm effects on sexuality has been demonstrated.
MYTHS AND MISCONCEPTIONS
1. The risk of having a hysterectomy is increased after tubal
ligation.
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• No-scalpel vasectomy38,47 is done through a tiny puncture opening in the scrotal skin; the rest of the technique is identical to the conventional procedure. No skin
sutures are needed. The operating time is reduced to
about one-half of the time of the conventional method.38
Other approaches to male sterilization involve percutaneous
chemical occlusion of the vas,48 or use of silver, silicone rubber–silver, or tantalum ring clips — the latter of which is
compatible with reversible vasectomy.1,47
option for women who are poor candidates for reversal
surgery.23
IN VITRO FERTILIZATION AND FAILED REVERSAL
In 37 couples in whom reversal of sterilization either failed or
was not attempted, the probability of pregnancy after IVF related more to patient age than to previous fertility. Compared to
a control group of women with tubal pathology, women who
underwent tubal ligation below age 38 produced a similar number of oocytes and an identical number of embryos for transfer.26
INDICATIONS
2.VASECTOMY
This method is suitable only for men who seek a permanent
method of contraception.
EFFICACY
Pregnancy rates following vasectomy vary from 0% to 2.2%
with any occlusion method.35,36 No carefully controlled studies have compared the different occlusion methods.36
Failure rate of vasectomy is also measured through the occurrence of recanalization. Because spermatozoa persist in the seminal vesicles, and thus in the ejaculate, for 2 to 3 months or 10 to
30 ejaculations after vasectomy, recanalization cannot be assessed
before such time or number of ejaculations have passed.37,38
Recanalization occurs in up to 2.6% of cases within 3 months
after vasectomy.35-37,39-42 It is important to realise that the main
reason for conception post-vasectomy is the failure of couples to
use back-up contraception immediately after the procedure.35,36
Use of an electrocoagulation technique,40,41 fascial interposition,41,43 removing a larger piece of vas,40 and experience
on the part of the physician44 may increase the efficacy of vasectomy, although well-controlled trials are yet to be done to confirm the importance of these factors. Sterile water irrigation of
the vas deferens does not seem to increase efficacy or reduce the
possibility of lingering sperm.45,46
CONTRAINDICATIONS
MECHANISM OF ACTION
RISKS AND SIDE EFFECTS
There are 2 principal techniques for vasectomy:
• Conventional vasectomy1 involves making 1 or 2
incisions in the scrotal skin; exposing, isolating, and dividing the vas; removing a 1.5-cm segment from each side;
sealing the ends of the vas with non-absorbable suture,
cautery-induced burn, or clips; and finally closing the
scrotal incision.
SIDE EFFECTS
Contraindications of the vasectomy include the following:
1. systemic health problems, such as allergy to local anaesthetics, immunosuppression, acute infectious diseases, or coagulation problems that cannot be controlled with vasopressin
2. local infection
3. local genital abnormalities impairing adequate localization
of the vas deferens, such as hernia, varicocele, hydrocele, or
tumour
4. uncertainty about permanent contraception
5. sexual dysfunction
NON-CONTRACEPTIVE BENEFITS
Vasectomy provides the same advantages as tubal ligation. In
addition, it is a simple intervention with very few complications, is easy to perform and to obtain, and does not require
general anaesthesia.
The side effects of the vasectomy include
• local pain and
• scrotal ecchymosis and swelling.
SHORT-TERM COMPLICATIONS
The following complications are less common with the noscalpel vasectomy38 and the use of suturing clips49:
• vasovagal reaction: up to 30%50,51
• hematoma: 1% to 10%40,44,49-51
• infection38,40,44,51: 0.4% to 16% (from mild erythema
and stitch abscess to fulminant Fournier’s gangrene)52
• granuloma formation from extruded sperm, either at the
vas or in the epididymis: 1% to 50% 40,42,51; this is
reduced when the proximal vas is left open.53,54 It pre-
Table 2. Probability of Pregnancy Following Reversal of Tubal
Ligation23
Technique
Clip
Ring
Pomeroy
Monopolar cautery
Pregnancy Rate (%)
90
76–80
67
52
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disposes to recanalisation51 and may cause significant pain
with palpation or during intercourse and ejaculation
• epididymitis and vasitis: 0.1% to 8%49,51,55
results is likely to be explained by bias, such that the studies with bias operating will have higher risk estimates than
those in which the bias has been adequately controlled.36
To date, there is no obvious biological mechanism for a relationship between vasectomy and prostatic cancer,75,78 and,
overall, the weight of evidence suggests that there is no association.
RARE COMPLICATIONS
• congestive epididymitis (reduced with open-ended vasectomy)53
• congestive orchalgia51
• vasocutaneous fistula51
• hydrocele49
• missed vas deferens or damage to scrotal structures49,51
• impotence and depression, which usually respond to psychological treatment51; improved psychosexual adjustment and enjoyment is usually reported following
vasectomy.56
INITIATION
Taking a medical and a contraceptive history is essential. Key
elements in the medical history are the patient’s age, marital status, spouse’s age, type of relationship, number and age of children, contraceptive experience, reasons for sterilization, systemic
health problems, and use of medication that may affect coagulation. It is important to inquire about genital anomalies or diseases and about sexual dysfunction. Examination of the genital
area is usually sufficient. Other tests and examinations are done
if medically necessary. Measurement of haemoglobin is usually
unnecessary for men before vasectomy.
Use of effective contraception is warranted until the time
semen analysis shows no spermatozoa. Since post-sterilization
regret is common, careful pre-surgery counselling to ensure
awareness of risk factors is essential. Information about the type
of operation — including risks and benefits, the availability of
alternative methods of family planning, the possibility of failure, and the possibility of reversal — must all be discussed so
that the individual can provide informed consent for surgical
sterilization. A consent document, readily understandable in
the individual’s own language, must be signed. It is recommended that the sterilization be performed a few weeks after
the initial interview, to allow more consideration of the choice
of sterilization. Written information may be useful.
LONG-TERM COMPLICATIONS
IMMUNOLOGICAL CONSEQUENCES
It is now well documented that one-half to two-thirds of vasectomized men develop circulating antibodies to sperm after
vasectomy,57 and that antibodies may persist for as long as 10
years after surgery.58 However, several studies55,57,58 did not
report any other laboratory abnormalities, nor immunological
diseases of any kind.57,59,60
CARDIOVASCULAR DISEASES
Following the identification of a marked increase of atherosclerosis in vasectomized cynomolgus monkeys fed high-cholesterol
diets,61,62 several large studies (more than 4000 men with observation over 20 years)59,60,63 explored the possible relationship
between cardiovascular diseases and vasectomy. None found any
significant association, and the estimates of relative risk were
always near the reference point.59,60,63-68 Stroke is the only vascular disease still requiring more long-term studies; at the present time, there does not seem to be any increased risk of stroke
in vasectomized men.36,58
MONITORING
No sports or physical strain should be undertaken for 7 days
post-operatively; sexual intercourse is prohibited for 5 days, and
local or systemic analgesia (ice pack, acetaminophen) can be
used if necessary. Post-operative warning signs should be
described, specifically extended scrotal edema, severe pain, or
fever. The physician should be made aware as quickly as possible if any of these conditions are present.
Standard practice is to require 2 consecutive azoospermic
samples, usually at 3 and 4 months, to confirm success.79
If the semen analysis shows the presence of motile spermatozoa in 2 consecutive samples, 3 months or more after vasectomy, a repeat procedure is required.44
If the semen analysis shows the presence of non-motile spermatozoa, one year or more after surgery, a cautious assurance
of sterilization can be given36; annual semen tests may be undertaken for additional reassurance.42
TESTICULAR CANCER
Although a few studies reported an association between vasectomy
and testicular cancer,69-71 most large studies did not find evidence
of any risk of testicular cancer in vasectomized men.36,58,59,72,73
MYTHS AND MISCONCEPTIONS
1. Vasectomy increases the risk of prostate cancer.
Fact: In population-based or hospital-based case-control
studies, odds ratios for the risk of prostate cancer in vasectomized men ranged from 0.5 to 6.7,36,74-76 while in large
cohort studies the relative risks varied from 0.8 to 2.1.36,77
The findings concerning the association between vasectomy
and prostate cancer suggest that the heterogeneity of study
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choice of procedure is made. (Grade A)
2. Before recommending a transcervical sterilization (cornual occlusion technique), extensive counselling should
be offered and the permanence of the procedure reinforced. (Grade B)
3. Counselling before sterilization should include discussion of alternative contraceptive methods. Counselling
should address the risks, complications, potential for
regret, and failure rates associated with the procedure.
(Grade B)
4. New techniques of female and male sterilization should
be available to all Canadians. (Grade C)
TROUBLESHOOTING
REVERSAL
Vasectomy reversal may be performed under local, regional, or
general anaesthesia.14 Various techniques are used (vasovasostomy or vasoepididymostomy, microsurgery or macrosurgery,
one-layer or two-layer), and success depends on the patency of
both ends of the vas and on the sperm quality.14,80 The sperm
count rises slowly after vasectomy reversal, and usually reaches
a plateau by 6 months after surgery. The chance of effective
recanalization and pregnancy declines with increasing time from
the original procedure14,80 (see Table 3); however, even after prolonged obstructive intervals or in men with older female partners,81 vasectomy reversal may offer comparable success rates
to intracytoplamic sperm injection. Before performing vasectomy reversal, counselling should focus on the fertility potential of the partner, potential complications, the probability of
success of the reversal, and cost-effectiveness.
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SUMMARY STATEMENTS
1. Vasectomy is a less invasive and more cost-effective sterilization procedure than conventional tubal ligation. (Level II-2)
2. Female sterilization using newer transcervical (cornual occlusion) techniques is effective, safe, and less invasive (Level II-2),
but virtually impossible to reverse. (Level III)
3. Although tubal ligation and vasectomy are considered safe
and very effective family planning methods, complications
may occur and failure is possible, even several years after the
procedure. (Level II-2)
4. Regret after sterilization is not infrequent, and is likely to be
associated with the following factors (Level II-2):
• young age at the time of sterilization
• having small children at the time of sterilization
• sterilization performed soon after delivery, Cesarean section, induced abortion, or the loss of a child
• when there is discord in the relationship
RECOMMENDATIONS
1. Couples choosing a sterilization procedure should be
informed that vasectomy carries fewer risks than tubal
ligation. However, social, cultural, and individual
considerations should be taken into account before a
Table 3. Probability of Pregnancy Following Vasectomy
Reversal14,80
Time Since
Vasectomy
Less than 3 years
3 to 8 years
9 to 14 years
More than 14 years
Sperm in the
Semen (%)
Pregnancy (%)
97
88
79
71
76
53
44
30
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1987;136:650.
18. Hillis SD, Marchbanks PA,Tylor LR, Peterson HB. Poststerilization
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20. Jamieson DJ, Kaufman SC, Costello C, Hillis SD, Marchbanks PA,
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21. Holman CD,Wisniewski ZS, Semmens JB, Rouse IL, Bass AJ. Populationbased outcomes after 28,246 in-hospital vasectomies and 1,902 vasovasostomies in Western Australia. BJU Int 2000;86(9):1043–9.
22. Potts JM, Pasqualotto FF, Nelson D,Thomas AJJR, Agarwal A. Patient
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24. Ekman Ehn B, Liljestrand J. A long-term follow-up of 108 vasectomised
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25. Lam A, Rosen DMB. Laparoscopic bowel and vascular complications:
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26. Sitko D, Commenges-Ducos M, Roland P, Papaxanthos-Roche A,
Horovitz J, Dallay D. IVF following impossible or failed surgical reversal
of tubal sterilization. Hum Reprod 2001;16(4):683–5.
27. Adair CD, Benrubi GI, Sanchez-Ramos L, Rhatigan R. Bilateral tubal
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1994;39(2):131–3.
28. Geber S, Caetano JP. Doppler colourflow analysis of uterinal and ovarian arteries prior to and after surgery for tubal sterilisation: a prospective study. Hum Reprod 1996;11(6):1195–8.
29. Taner CE, Hakverdi KU, Erden AC, Satici O. Menstrual disorders and
pelvic pain after sterilisation. Adv Contracept 1995;11(4):309–15.
30. Ruifang W, Zhenhai W, Lichang L, Fenger Z, Xinglin G. Relationship
between prostaglandin in peritoneal fluid and pelvic venous congestion
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31. Hakverdi KU,Taner CE, Erden AC, Satici O. Changes in ovarian function
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33. Stergachis A, Shy KK, Grothaus LC,Wagner EH, Hecht JA, Anderson G,
et al.Tubal sterilization and the long-term risk of hysterectomy. JAMA
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34. Santow G, Bracher M. Long term risk of hysterectomy among 80,007
sterilized and comparison women at Kaiser Permanente, 1971–1987.
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35. Population Information Program.Vasectomy: safe and simple. Population
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37. Richardson DW, Aitken RJ, Loudon NB.The functional competence of
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38. Nirapathpongporn A, Huber DH, Krieger JN. No-scalpel vasectomy at
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39. Alderman PM. General and anomalous sperm disappearance of sperm
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40. Denniston GC.Vasectomy by electrocautery: outcomes in a series of
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41. Esho JO, Cass AS. Recanalization rate following methods of vasectomy
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42. Alderman PM.The lurking sperm: a review of failures in 8879
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abnormalities, and perinatal and maternal mortality.4 Contraception should be recommended until menopause is confirmed
clinically (usually when amenorrhea has been present for 1 year).1
Most contraceptive options are open to women in perimenopause. This section will discuss some of the considerations
for perimenopausal women, but the details of the methods are
located in the respective sections of these guidelines. The choice
of method will be moderated by the possible desire for noncontraceptive benefits or the desire for permanent contraception.
Women who are not in a steady relationship may choose an intermittent method and may need the protection against sexually
transmitted infections (STIs) that a barrier method provides.
70. Thornhill JA, Conroy RM, Kelly DG,Walsh JJ, Fitzpatrick JM. An evaluation of predisposing factors for testis cancer in Ireland. Eur Urol
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71. Cale AR, Farouk M, Prescott RJ,Wallace IW. Does vasectomy accelerate
testicular tumour? Importance of testicular examination before and
after vasectomy. BMJ 1990;300:370.
72. Moller H, Knudsen LB, Lynge E. Risk of testicular cancer after vasectomy: cohort study of over 73 000 men. BMJ 1994;309:295–8.
73. Rosenberg L, Palmer JR, Zauber AG,Warshauer ME, Strom BL, Harlap S,
Shapiro S.The relation of vasectomy to the risk of cancer. Am J Epidemiol 1994;140(5):431–8.
74. Rosenberg, L, Palmer JR, Zauber AG,Warshauer ME, Stolley, PD,
Shapiro S.Vasectomy to the risk of prostate cancer. Am J Epidemiol
1990;132:1051–5.
75. John EM,Whittemore AS,Wu AH, Kolonel LN, Hislop TG, Howe GR,
et al.Vasectomy and prostate cancer: results from a multiethnic casecontrol study. J Natl Cancer Inst 1995;87:662–9.
76. Mettlin C, Natarajan N, Huben R.Vasectomy and prostate cancer risk.
Am J Epidemiol 1990;132:1050–61.
77. Giovannucci E, Ascherio A, Rimm EB, Colditz GA, Stampfer MJ,
Willet WC. A prospective cohort study of vasectomy and prostate
cancer in US men. JAMA 1993;269:873–7.
78. Howards SS. Possible biological mechanisms for a relationship between
vasectomy and prostatic cancer. Eur J Cancer 1993;29A:1061–4.
79. Harris NM, Holmes SA. Requests for vasectomy: counselling and
consent. J R Soc Med 2001;94(10):510–1.
80. Hendry WF. Vasectomy and vasectomy reversal. Br J Urol
1994;73(4):337–44.
81. Deck AJ, Berger RE. Should vasectomy reversal be performed in men
with older female partners? J Urol 2000;163:105–9.
ORAL CONTRACEPTIVES
The use of combined oral contraceptives (OCs) is no longer
contraindicated in non-smoking women over age 35.5,6 Noncontraceptive benefits may be especially helpful in this age
group. Low-dose OCs containing 20 to 35 µg of ethinyl estradiol offer many benefits for the perimenopausal woman. A
combined OC containing 20 µg of ethinyl estradiol has been
shown to provide effective contraception, reduce menstrual
cycle irregularity, decrease bleeding, and relieve menopausal
symptoms.7 Important additional benefits of such treatment
include a decrease in the risk of ovarian cancer8 and endometrial cancer,9 reduced dysmenorrhea and menorrhagia,10 and a
lower risk of functional ovarian cysts.11,12 There is a decreased
risk of hereditary cancers.13 Longer duration of use is associated with decreased risk. The risk of colorectal cancer may also be
reduced with OC use.14,15
Women taking a combined OC may experience a return of
symptoms during the hormone-free interval, although supplementation during that time with a low dose of estrogen may be
helpful. Alternatively, combined OCs may be taken continuously; this may have a number of advantages, including a
decreased incidence of pelvic pain, headaches, bloating/swelling,
and breast tenderness for women who experience these symptoms during the hormone-free interval.16
CHAPTER 11: CONTRACEPTION —
MEETING SPECIAL NEEDS
Nathalie Fleming, MD, FRCSC,1 Margaret Morris, MD,
FRSCS,2 Helen Pymar, MD, MPH, FRCSC,3 Thirza Smith,
MD, FRCSC4
1Ottawa
ON
MB
3Toronto ON
4Saskatoon SK
2Winnipeg
At different stages of a woman’s reproductive life, or in the face
of disability, contraceptive needs require a unique approach.
The special needs of these circumstances are considered in the
following sections.
INTRAUTERINE DEVICE
1. CONTRACEPTION IN PERIMENOPAUSE
The intrauterine device (IUD) is an effective method of contraception that is well-suited to perimenopause. The copperbearing IUD has been shown to decrease the risk of endometrial
cancer.17 The levonorgestrel-containing intrauterine system
(LNG-IUS) decreases the amount of blood flow and may lead
to amenorrhea.18
Menorrhagia responds favourably to use of the LNG-IUS.
In 2 studies of women scheduled to undergo hysterectomy for
menorrhagia, 64% to 80% of women randomized pre-operatively to LNG-IUS insertion subsequently cancelled their hysterectomy, compared with 9% to 14% of women randomized
INTRODUCTION
Perimenopause is characterized by fluctuating hormone levels,
irregular menstrual cycles, and the onset of symptoms such as
hot flashes and insomnia that may increase in number and
severity as menopause approaches.1,2 While women over the
age of 40 may have difficulty in conceiving, most are still fertile and do not seek pregnancy.3
Pregnancy in perimenopause is associated with increased
obstetrical and genetic risks, including miscarriage, fetal
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to receive other medical treatments.19,20 Dysmenorrhea may
also improve in LNG-IUS users.21
2. Prior JC. Perimenopause: the complex endocrinology of the
menopausal transition. Endoc Rev 1998;19:398–428.
3. Schmidt-Sarosi C. Infertility in the older woman. Clin Obstet Gynecol
1998;30:24–9.
4. Hosseinzadeh M, Jolly EE. Fertility in the mature woman. J Obstet
Gynaecol Can 1997;19:611–8.
5. Inman WH,Vessey MP, Westerholm B, Engelund A.Thrombotic disease
and the steroidal content of oral contraceptives: a report to the Committee on Safety of Drugs. BMJ 1970;2:203–9.
6. Rosenberg L, Palmer JR, Rao RS, Shapiro S. Low-dose oral contraceptive
use and the risk of myocardial infarction. Arch Int Med 2001;161:
1065–70.
7. Casper RF, Dodin S, Reid RL; Study Investigators.The effect of 20 µg
ethinyl estradiol/1 mg norethindrone acetate (Minestrin), a low-dose
oral contraceptive, on vaginal bleeding patterns, hot flashes, and quality
of life in symptomatic perimenopausal women. Menopause 1997;4:
139–47.
8. Schlesselman JJ. Net effect of oral contraceptive use on the risk of cancer in women in the United States. Obstet Gynecol 1995;85:793–801.
9. Jick SS,Walker AM, Jick H. Oral contraceptives and endometrial cancer.
Obstet Gynecol 1993;82:931–5.
10. Derzko CM. Perimenopausal dysfunctional uterine bleeding: physiology
and management. J Soc Obstet Gynaecol Can 1997;19:589–600.
11. Speroff L. Management of the perimenopausal transition. Contemp
Obstet Gynecol 2000;10:14–37.
12. Shaaban MM.The perimenopause and contraception. Maturitas 1996;
23:181–92.
13. Narod SA, Risch H, Moslehi R, Dorum A, Neuhausen S, Olsson H, et al.
Oral contraceptives and the risk of hereditary ovarian cancer. N Engl J
Med 1998;339:424–8.
14. Fernandez E, La Vecchia C, Balducci A, Chatenoud L, Franceschi S,
Negri E. Oral contraceptives and colorectal cancer risk: a meta-analysis.
Br J Cancer 2001;84:721–7.
15. Troisi R, Schairer C, Chow WH, Schatzkin A, Brinton LA, Fraumeni JF Jr.
Reproductive factors, oral contraceptive use, and risk of colorectal cancer. Epidemiology 1997;8:75–9.
16. Sulak P, Kuehl T, Ortiz M, Shull B. Acceptance of altering the standard
21-day/7-day oral contraceptive regimen to delay menses and reduce
hormone withdrawal symptoms. Am J Obstet Gynecol 2002;186:
1142–9.
17. Benshushan A, Paltiel O, Rojansky N, Brzezinski A, Laufer N. IUD use
and the risk of endometrial cancer. Eur J Obstet Gynecol
2002;105:166–9.
18. Onyeka BA. Levonorgestrel-releasing (20 mcg/day) intrauterine systems
(Mirena) compared with other methods of reversible contraceptives.
Br J Obstet Gynaecol 2001;98:576–82.
19. Lahteenmaki P, Haukkamaa M, Puolakka J, Riikonen U, Sainio S,
Suvisaari J, et al. Open randomised study of use of levonorgestrel
releasing intrauterine system as alternative to hysterectomy. BMJ
1998;316:1122–6.
20. Hurskainen R,Teperi J, Rissanen P, Aalto AM, Grenman S, Kivela A, et al.
Quality of life and cost-effectiveness of levonorgestrel-releasing
intrauterine system versus hysterectomy for treatment of menorrhagia:
a randomised trial. Lancet 2001;357:273–7.
21. Barrington JW, Bowens-Simpkins P.The levonorgestrel intrauterine
system in the management of menorrhagia. Br J Obstet Gynaecol
1997;104:614–6.
22. Betsey EM;Task Force on Long-Acting Systemic Agents for Fertility
Regulation. Menstrual bleeding patterns in untreated women and with
long-acting methods of contraception. Adv Contracept 1991;7:257–70.
23. Sangi-Haghpeykar H, Poindexter AN III, Bateman L, Ditmore JR. Experiences of injectable contraceptive users in an urban setting. Obstet
Gynecol 1996;88:227–33.
24. Broome M, Fotherby K. Clinical experience with the progestogen-only
pill. Contraception 1990;42:489–95.
25. Hillis SD, Marchbanks PA,Tylor LR, Peterson HB. Post-sterilization
regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol 1999;93:889–95.
PROGESTIN-ONLY METHODS
The use of depot medroxyprogesterone acetate or the progestinonly pill are methods that can be used for contraception in perimenopause. These methods may be associated with
amenorrhea22 or irregular vaginal bleeding.23,24
BARRIER METHODS
Barrier methods may be appropriate for use in perimenopausal
women. Since an unplanned pregnancy may be more undesirable in this age group, the relatively lower contraceptive effectiveness of barrier methods may be a disadvantage.
PERMANENT CONTRACEPTION
In the perimenopausal age group, many couples choose male
or female sterilization if they are certain further pregnancy is
not desired. Post-sterilization regret is decreased in this age
group.25 Menstrual abnormalities are not usually worsened after
tubal ligation,26 but the positive effects of combined OCs, the
copper IUD, or the LNG-IUS will be lost once their use is discontinued.
Other contraceptive methods are not contraindicated solely by age and may also be valuable for some women.
SUMMARY STATEMENTS
1. In addition to providing effective contraception, low-dose
combined OCs provide non-contraceptive benefits for healthy,
non-smoking perimenopausal women. Non-contraceptive
benefits include suppression of vasomotor symptoms (Level I),
cycle control, decreased incidence of anemia (Level II-1), and
decreased incidence of endometrial cancer. (Level II-2)
2. The IUD may be a suitable contraceptive method for perimenopausal women. The levonorgestrel-releasing IUS
(LNG-IUS) decreases heavy bleeding and may eliminate the
need for hysterectomy. (Level I)
RECOMMENDATION
1. Health-care providers should emphasize the need for
effective contraception in perimenopausal women. Noncontraceptive benefits of each method should be taken
into account when counselling these women. (Grade A)
REFERENCES
1. North American Menopause Society. Clinical challenge of the
perimenopause: consensus opinion of The North American Menopause
Society. Menopause 2000;7:5–13.
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26. Peterson HB, Jeng G, Folger SG, Hillis SA, Marchbanks PA,Wilcox LS;
U.S. Collaborative Review of Sterilization Working Group.The risk of
menstrual abnormalities after tubal sterilization: findings from the U.S.
Collaborative Review of Sterilization. N Eng J Med 2000;343:1681–7.
INTRAUTERINE DEVICE
Women who are breastfeeding may be good candidates for
use of an intrauterine device (IUD). The IUD can be inserted
immediately postpartum (within 10–15 minutes after delivery
of the placenta). Women who have an IUD inserted immediately after delivery are at higher risk of expulsion and uterine
perforation than women who have an IUD inserted later.14 In
most circumstances, it is prudent to wait until the uterus is completely involuted, usually at 4 to 6 weeks postpartum, before
inserting an IUD. Women should wait until 6 weeks postpartum to have the LNG-IUS inserted.
2. POSTPARTUM CONTRACEPTION
Barrier methods of contraception and spermicides may be used
in breastfeeding and postpartum women when they are ready
to resume sexual activity. If a woman chooses a hormonal
method of contraception, certain restrictions may apply.1
COMBINED ORAL CONTRACEPTIVES
In breastfeeding women, use of combined oral contraceptives
(OCs) may diminish both the quality and quantity of breast
milk in the postpartum period. It is suggested that combined
OCs should not be used until after lactation is well established
(usually 6 weeks postpartum).2 A significant amount of progestational component is present in the breast milk when the
mother is taking combined OCs. Nevertheless, no adverse
effects have thus far been identified. In an 8-year follow-up
study of children breastfed by mothers using combined OCs,
no effect could be detected on diseases, intelligence, or psychological behavior.3,4
If the woman is not breastfeeding, combined OCs may be
introduced 3 to 4 weeks postpartum.2
LACTATIONNAL AMENORRHEA
Some women prefer to avoid all hormonal contraceptive methods while they breastfeed. For these women, it is important to
emphasize that only amenorrheic women who exclusively breastfeed at regular intervals, even during the night, have this contraceptive effect of lactation during the first 6 months. Supplements
increase the risk of ovulation even in the absence of menstruation.15 This method is dealt with in more detail in Chapter 9.
SUMMARY STATEMENTS
1. The use of combined OCs decreases breast milk production.
(Level I)
2. Use of progestin-only preparations has not been shown to
decrease breast milk production. The small amounts of
steroid hormones secreted into breast milk do not have an
adverse effect on the baby. (Level II-2)
PROGESTIN-ONLY PILLS
No adverse effects of contraceptive steroids secreted in breast
milk, from use of either combined OCs or the progestin-only
pill (POP), have been identified in infants.5-8 The POP provides a small increase in milk production and women using
them breastfeed a longer time.8
Progestins administered within the first 72 hours after delivery may theoretically interfere with the fall in serum progesterone levels that triggers lactogenesis, thereby interfering with
breast milk production. However, a prospective study did not
detect any adverse effect on breastfeeding when progestin-only
contraceptive methods were used within the first 72 hours after
delivery.7
RECOMMENDATIONS
1. Initiation of combined OC use should be delayed until
breastfeeding is established, usually by 6 weeks postpartum. If the woman is not breastfeeding, combined OCs
can be started at 3 to 4 weeks postpartum. (Grade B)
2. Progestin-only methods should be considered as contraceptive options for postpartum women, regardless of
breastfeeding status, and may be introduced immediately after delivery. (Grade B)
INJECTABLE PROGESTIN
REFERENCES
Administration of depot medroxyprogesterone acetate (DMPA)
has been shown to be an effective method of postpartum contraception with little or no effect on breast milk production or
on infant development.9-13
It may be preferable to wait until breast milk is established
before giving the first dose of DMPA. If the woman is not
breastfeeding, the first DMPA dose can be given immediately
after delivery.
JOGC
1. Briggs GG, Freeman RK,Yaffe SJ, editors. Drugs in pregnancy and lactation: a reference guide to fetal and neonatal risk. 6th ed. Philadelphia:
Lippincott Williams & Wilkins; 2001.
2. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
3. Shikary ZK, Betrabet SS, Patel ZM, Patel S, Joshi JV,Toddywala VS, et al.
ICMR (Indian Council of Medical Research) Task Force study on hormonal contraception: transfer of levonorgestrel (LNG) administered
through different drug delivery systems from the maternal circulation
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4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
termination often require contraceptive counselling at the time
of their procedure. Women may ovulate as early as 16 days after
the procedure.1 There is a rapid return (within 1 week) of estrogen and progesterone levels to near normal range after abortion.1
The patient’s visit at the clinic to seek an abortion offers a
good opportunity for the health-care provider to talk about contraceptive options.2,3 Women seeking abortion due to contraceptive failure or non-use of contraception should not leave the
clinic without receiving counselling on how to avoid unwanted pregnancy in the future. Advance provision of emergency
contraception should be considered for all post-abortion
patients. The following Table 1 lists the recommended timing
of initiation of contraceptive options after abortion.
into the newborn infant’s circulation via breast milk. Contraception
1987;35:477–86.
Betrabet SS, Shikary ZK,Toddywalla VS,Toddywalla SP, Patel D, Saxena BN.
ICMR Task Force study on hormonal contraception: transfer of norethisterone (NET) and levonorgestrel (LNG) from a single tablet into
the infant’s circulation through the mother’s milk. Contraception
1987;35:517–22.
Truitt ST, Frazer AB, Grimes DA, Gallo MF, Schulz KF. Combined
hormonal versus nonhormonal versus progestin-only contraception in
lactation (Cochrane Review). In:The Cochrane Library, Issue 4 2003.
Oxford: Update Software.
World Health Organization Task Force on Oral Contraceptives. Effects
of hormonal contraceptives on breast milk composition and infant
growth. Stud Fam Plann 1988;19(6 Pt 1):361–9.
Halderman LD, Nelson AL. Impact of early postpartum administration
of progestin-only hormonal contraceptives compared with
nonhormonal contraceptives on short-term breast-feeding patterns.
Am J Obstet Gynecol 2002;186:1250–8.
Tankeyoon M, Dusitsin N, Chalapati S, Koetsawang S, Saibiang S, Sas M,
et al. Effects of hormonal contraceptives on milk volume and infant
growth.WHO Special Programme of Research, Development, and
Research Training in Human Reproduction;Task Force on Oral Contraceptives. Contraception 1984;30:505–22.
Mishell DR Jr. Pharmacokinetics of depot medroxyprogesterone
acetate contraception. J Reprod Med 1996;41(5 Suppl):381–90.
SOGC Committee Opinion. Injectable medroxyprogesterone acetate
for contraception. Policy statement No. 94. J Soc Obstet Gynaecol Can
2000; August: 14–8.
Pardthaisong T,Yenchit C, Gray R.The long-term growth and development of children exposed to Depo-Provera during pregnancy or lactation. Contraception 1992;45:313–24.
Borgatta L, Murthy A, Chuang C, Beardsley L, Burnhill MS. Pregnancies
diagnosed during Depo-Provera use. Contraception 2002;66:169–72.
Hatcher RA, Schnare S. Ask the experts: progestin-only contraceptives.
Contracept Technol Update 1993;14:114–5.
Grimes D, Schulz K, van Vliet H, Stanwood N. Immediate post-partum
insertion of intrauterine devices (Cochrane Methodology Review). In:
The Cochrane Library, Issue 4 2003.
Visness CM, Kennedy KI, Gross BA, Parenteau-Carreau S, Flynn AM,
Brown JB. Fertility of fully breastfeeding women in the early postpartum period. Obstet Gynecol 1997;89:164–7.
SUMMARY STATEMENT
1. Legalized abortion is associated with a lower incidence of
abortion-related maternal mortality. (Level II-2)
RECOMMENDATIONS
1. Contraceptive counselling should be offered at the time
of abortion, and contraceptive methods should be provided immediately following the procedure. (Grade A)
2. Canadian women should have access to safe abortion procedures regardless of geographical location. (Grade A)
REFERENCES
1. Lahteenmaki P. Postabortal contraception. Ann Med 1993;25:185–9.
2. Garg M, Singh M, Mansour D. Peri-abortion contraceptive care: can we
reduce the incidence of repeat abortions? J Fam Plann Reprod Health
Care 2001;27:77–80.
3. Ortayli N, Bulut A, Nalbant H.The effectiveness of preabortion contraceptive counseling. Int J Gynecol Obstet 2001;74:281–5.
4. Paul M, Lichtenberg E, Borgatta L, Grimes D, Stubblefield P. A clinician’s
guide to medical and surgical abortion. Philadelphia, PA: Churchill Livingstone; 1999.
5. El-Tagy A, Sakr E, Sokal D, Issa A. Safety and acceptability of post-abortal
3. POST-ABORTION CONTRACEPTION
Women who have had a miscarriage or elective pregnancy
Table 1. Recommended Initiation of Contraceptive Options After Abortion
Contraceptive Method
Initiation (in Relation to Abortion)
Comment4
Female sterilization
Start at time of abortion for first and
early–second trimester; can be done
laparoscopically and by minilaparotomy for
second trimester.
Start anytime from evening of surgery to 5 days
after surgery.
Start on the day of abortion.
Consider interval for severe anemia.
Ensure adequate counselling.
Combination oral contraceptives
Progestin-only oral contraceptives
Injectable contraceptives
Start immediately after abortion, or up to 5
days afterwards.
IUD/IUS
Start at time of abortion in first trimester or
during/after first menses after abortion.
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Nausea may be confused with continuing
pregnancy if started right away.
Breakthrough bleeding may cause confusion
post-operatively.
Ensure plans for next injection are made.
Breakthrough bleeding may cause confusion
post-operatively.
No significant increase in bleeding,
perforation, pain with immediate vs. delayed
initiation in first trimester.5 Higher rates of
expulsion if greater than 12 weeks compared
with shorter gestations.6
However, to give valid consent for medical treatment, an
individual under the legal age of consent must be deemed to be
a “mature minor.” Determining whether or not an adolescent
is a “mature minor” requires an assessment of whether or not
the young person’s physical, mental, and emotional development will allow for full appreciation of the nature and consequences of a proposed treatment, including the consequences
of refusal of such treatment.6
IUD insertion and the importance of counseling. Contraception
2003;67:229–34.
6. Stanwood N, Grimes D, Schulz K. Insertion of an intrauterine contraceptive device after induced or spontaneous abortion: a review of the
evidence. Br J Obstet Gynaecol 2001;108:1168–73.
4. CONTRACEPTION FOR THE ADOLESCENT
Most contraceptive options are a good choice for adolescents.
Adolescents are commonly involved in serial monogamous relationships in which they are less likely to use a contraceptive
method on a regular basis. They are more willing to seek contraceptive advice in a steady relationship. In all these cases, double protection against pregnancy and sexually transmitted
infections (STIs) should always be recommended. In this specific age group it is also important to emphasize that the use of
barrier methods does not always prevent viral STIs such as herpes and the human papilloma virus (HPV).1,2
CLINICAL CONSIDERATIONS
The following should be considered in determining the optimal hormonal contraceptive method for a female adolescent:
• There is no evidence that the estrogen in current low-dose
combined OCs has any effect on growth.7
• In users of low-dose combined OCs, weight gain is minimal and is often related to normal weight gain for age in
the adolescent population. Combined OC users have not
been shown to have any significant weight gain on therapy.8-12
• Combined OC use appears to have a favourable effect on
bone mineral density.13-15
• In one study, 56% of DMPA users reported an increase
in weight (mean gain of 4.1 kg), while 44% either lost
weight or maintained their baseline weight (mean loss of
1.7 kg).16 Other studies have failed to find an effect of
DMPA on weight.17-19 Weight gain associated with
DMPA use is thought to be due to appetite stimulation
and a possible mild anabolic effect.20
• Adolescent mothers using DMPA for contraception have
a higher method continuation rate and a lower incidence
of repeat pregnancy at 12 months postpartum than those
selecting combined OCs during the same period.21
BACKGROUND
It is important to note that in Canada
• 11% of 15-year-olds, 27% of 16-year-olds, 42% of 17year-olds, and 55% of 18-year-olds have had sexual intercourse.3
• between 85% and 91% (depending on age) used contraception at the time of first intercourse.3
• among coitally experienced adolescents, none were currently using spermicidal methods, none were sterilized,
and none were using IUDs. As in other age groups, the
dominant methods used by coitally experienced teenagers
aged 15 to 18 were OCs (66%) and condoms (44%);
others included withdrawal (6%) and DMPA (6%); and
11% reported no current sexual activity.3
The most important reasons adolescents cite for not using
contraceptive methods when they are sexually active are as
follows4:
• sexual activity was unexpected and unplanned;
• a lack of information and knowledge about contraceptives and where to get them;
• fear of medical procedures;
• fear of judgmental attitudes and resistance from healthcare providers; and
• fear of lack of confidentiality.
ADHERENCE TO CONTRACEPTIVE CHOICE
The greatest challenges in adolescent users of combined OCs are
incorrect or inconsistent use and high discontinuation rates.22
Three months after beginning, 76% of teenage women
remain on oral contraceptives, and 50% continue after 12
months.23 The most common reason given for discontinuing
hormonal contraception is side effects,24 especially breakthrough
bleeding.20,23
Many adolescents believe that their risk of getting cancer or
blood clots while using hormonal contraception is very high. It
is possible that the adolescent sees unscheduled bleeding or
other side effects as an indication of a serious consequence such
as cancer. They may also believe that these effects are long-term,
lead to sterility, or affect the health of future offspring.24 As a
result, they will feel less confident about the efficacy of the contraceptive. This can lead to non-compliance and discontinuation of the contraceptive.25
LEGAL ASPECTS
There is no lower age limit for prescribing hormonal contraceptives. The medical and social risks of unplanned pregnancy
exceed the risks of taking hormonal contraceptives; the World
Health Organization states that age alone does not constitute a
medical reason for denying any available contraceptive method
to adolescents.5
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.cmpa-acpm.ca> Web site updated 2003. Accessed February 16, 2004.
7. Elgan C, Samsioe G, Dykes AK. Influence of smoking and oral contraceptives on bone mineral density and bone remodeling in young
women: a 2-year study. Contraception 2003;67(6):439–47.
8. Endrikat J, Gerlinger C, Cronin M,Wessel J, Ruebig A, Rosenbaum P,
et al. Body weight change during use of a monophasic oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene
with a comparison of the women who completed versus those who
prematurely discontinued intake. Eur J Contracept Reprod Health Care
2001;6(4):199–204.
9. Coney P, Washenik K, Langley RG, DiGiovanna JJ, Harrison DD.Weight
change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials. Contraception
2001;63(6):297–302.
10. Gupta S.Weight gain on the combined pill: is it real? Hum Reprod
Update 2000;6(5):427–31.
11. Vessey MP, Painter R, Powell J. Skin disorders in relation to oral contraception and other factors, including age, social class, smoking, and body
mass index: findings in a large cohort study. Br J Dermatol
2000;143(4):815–20.
12. Endrikat J, Hite R, Bannemerschult R, Gerlinger C, Schmidt W. Multicenter, comparative study of cycle control, efficacy, and tolerability of two
low-dose oral contraceptives containing 20 microg ethinylestradiol/100
microg levonorgestrel and 20 microg ethinylestradiol/500 microg
norethisterone. Contraception 2001;64(1):3–10.
13. Kuohung W, Borgatta L, Stubblefield P. Low-dose oral contraceptives
and bone mineral density: an evidence-based analysis. Contraception
2000;61(2):77–82.
14. Borgelt-Hansen L. Oral contraceptives: an update on health benefits
and risks. J Am Pharm Assoc 2001;41(6):875–86.
15. Jensen JT, Speroff L. Health benefits of oral contraceptives. Obstet
Gynecol Clin North Am 2000;27(4):705–21.
16. Polaneczky M, Guarnaccia M. Early experience with the contraceptive
use of depot medroxyprogesterone acetate in an inner-city clinic
population. Fam Plann Perspect 1996;28:174–8.
17. Moore LL,Valuck R, McDougall C, Fink W. A comparative study of oneyear weight gain among users of medroxyprogesterone acetate,
levonorgestrel implants, and oral contraceptives. Contraception
1995;52:215–9.
18. Mainwaring R, Hales HA, Stevenson K, Hatasaka HH, Poulson AM,
Jones KP, et al. Metabolic parameter, bleeding, and weight changes in
U.S. women using progestin-only contraceptives. Contraception
1995;51:149–53.
19. Taneepanichskul S, Reinprayoon D, Jaisamrarn U. Effects of DMPA on
weight and blood pressure in long-term acceptors. Contraception
1999;59:301–3.
20. Rees HD, Bonsall RW, Michael RP. Pre-optic and hypothalamic neurons
accumulate [3H]medroxyprogesterone acetate in male cynomolgus
monkeys. Life Sci 1986;39:1353–9.
21. Templeman CL, Cook V, Goldsmith LJ, Powell J, Hertweck SP. Postpartum contraceptive use among adolescent mothers. Obstet Gynecol
2000;95(5):770–6.
22. Hewitt G, Cromer B. Update on adolescent contraception. Obstet
Gynecol Clin North Am 2000;27(1):143–62.
23. Kalagian W, Delmore T, Loewen I, Herman J, Busca C. Adolescent oral
contraceptive use: factors predicting compliance at 3 and 12 months.
Can J Hum Sex 1998;7:1–8.
24. Clark LR.Will the pill make me sterile? Addressing reproductive health
concerns and strategies to improve adherence to hormonal contraceptive regimens in adolescent girls. J Ped Adoles Gynecol
2001;14(4):153–62.
25. Sucato G, Gold MA. New options in contraception for adolescents.
Curr Womens Health Rep 2001;1(2):116–23.
26. Cromwell PF, Daley AM. Oral contraceptive pills: considerations for the
adolescent patient. J Ped Health Care 2000;14(5):228–34.
27. Peremans L, Hermann I, Avonts D,Van Royen P, Denekens J. Contraceptive knowledge and expectations by adolescents: an explanation by
focus groups. Patient Ed Counsel 2000;40(2):133–41.
STRATEGIES TO IMPROVE ADHERENCE
A supportive, encouraging, and non-judgmental environment,
where confidentiality is assured, is essential when counselling adolescents. It is also important to counsel them about the value of
dual protection for the prevention of both pregnancy and STI.26,27
The following strategies will increase the probability of an
adolescent adhering to a contraceptive plan:
1. Explain how the hormonal method works.
2. Dispel myths and misconceptions.
3. Demystify the side effects, and reassure the adolescent that
the minor side affects are usually short-lived.
4. Emphasize the non-contraceptive benefits of the hormonal
contraceptive.
5. Schedule frequent follow-ups.
6. Provide written material that lists myths and misconceptions,
non-contraceptive benefits, and side effects.
SUMMARY STATEMENTS
1. Age alone is not a reason to deny any available contraceptive
methods to adolescents.
2. A health-care provider can supply contraception to a minor
without parental consent as long as informed consent can
be obtained from the individual.
3. A pelvic examination is not a prerequisite for providing contraception or emergency contraception. The timing of the
pelvic examination may be negotiated with the adolescent.
(Level III)
RECOMMENDATIONS
1. Adolescents should have ready access to contraception
and methods of STI prevention. (Grade A)
2. Health-care providers should respect a patient’s right to
confidentiality. (Grade A)
3. The health-care provider should help to ascertain that
sexually active adolescents are involved in a consensual
relationship that is free of coercion and abuse. (Grade B)
REFERENCES
1. Greydanus DE, Patel DR, Rimsza ME. Contraception in the adolescent:
an update. Pediatrics 2001;107(3):562–73.
2. Bury JK. Some social aspects of providing contraception for under-16year-olds. Fertil Contraception 1980:4(1):1–6.
3. Fisher W, Boroditsky R, Morris B.The 2002 Canadian contraception
study. J Obstet Gynaecol Can. In Press 2004.
4. Rivera R, Cabra de Mello M, Johnson SL, Chandra-Mouli V. Contraception for adolescents: social, clinical, and service-delivery considerations.
Int J Gynecol Obstet 2001;75(2):149–63.
5. World Health Organization. Improving access to quality care in family
planning: medical eligibility criteria for contraceptive use. 2nd ed.
Geneva:WHO; 2001.
6. Canadian Medical Protective Association. Consent: a guide for Canadian
physicians. 3rd ed. Ottawa: CMPA; 1996. Available on-line at <www
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5. CONTRACEPTION IN INDIVIDUALS WITH
INTELLECTUAL DISABILITIES
LEVONORGESTREL INTRAUTERINE SYSTEM
The use of this system in women with mental disabilities has
not been examined. It provides effective management of menstrual problems as well as reversible contraception.14 However,
a general anaesthetic or profound sedation for insertion of the
device may be necessary for many disabled women.15 The possibility that the system may induce amenorrhea or a major
decrease in bleeding16 is usually considered a positive aspect by
the parents or caregivers.
Finding the most appropriate contraceptive method for the
mentally disabled young woman poses a tremendous challenge
to the health-care provider.
Women with mental disabilities may be at risk for pregnancy, sexually transmitted infections, and/or abuse, since
they
• lack knowledge of sexuality and contraception;
• may be very affectionate and trusting;
• struggle to be accepted, and may become compliant to
sexual advances.1
The parents of these young women may be concerned
about their daughters’ ability to cope with menses, the risk of
sexual exploitation,2 and pregnancy.3
Many will request medication to arrest menses and offer
contraception, while others may request permanent sterilization. Reproductive health services should not be coercive;
informed consent is required for all contraceptive methods.4,5
Contraception can prevent pregnancy, but does not replace
the need for a safe environment for these women.3 In addition,
counselling and assertiveness training to help them avoid abusive situations are necessary.2,6
The literature regarding management of menstrual hygiene
and contraception in a woman with a mental disability is sparse.
However, several medical options are available to improve menstrual hygiene and to provide contraception: low-dose combined oral contraceptives (OCs), depot medroxyprogesterone
acetate (DMPA), levonorgestrel intrauterine system (LNGIUS), and sterilization.
STERILIZATION
Health-care providers should be aware of the legal requirements
for obtaining informed consent for sterilization, including an
explanation of benefits and risks, options, and determination
of whether the person is competent to understand the information.2 When the person has a mental disability, it is even
more difficult for the physician to determine their capacity to
provide informed consent.17 Contraceptive sterilization of an
incompetent, mentally disabled person is illegal.4 Physicians
need to be very respectful and provide comprehensive information for the parents of these individuals, since they are frequently concerned about their responsibility for any offspring
if their daughter conceives.
SUMMARY STATEMENT
1. The non-therapeutic sterilization of any individual who is
not competent to give informed consent is illegal in Canada.
RECOMMENDATION
1. Health-care providers should include sexual health in the
counselling of women and men with intellectual disabilities, explore potential coercion and abuse and
should provide counselling to help them avoid coercive
and abusive situations. (Grade B)
LOW-DOSE COMBINED ORAL CONTRACEPTIVES
Oral medications must be well tolerated for combined OCs to
be a useful option for these women. Oral contraceptives may
be used in a cyclical, tri-cyclic (63 days on, 7 days off), or continuous fashion.7-9
The risk of venous thromboembolism may be increased significantly if the woman is confined to a wheelchair.10 The dose
of combined OCs used may need to be adjusted if the woman
also takes anticonvulsants.11
REFERENCES
1. Price MM. Physically, mentally disabled teens require special contraceptive care. Contracept Technol Update 1987;8:154–6.
2. Best K. Mental disabilities affect method options. Network Int Commun
Libr Automation 1999;19:19–22.
3. Grover SR. Menstrual and contraceptive management in women with
an intellectual disability. Med J Aust 2002;176:108.
4. Canadian Medical Association; Committee on Ethics. Statement on
contraceptive sterilization of the mentally retarded. CMAJ
1987;136:650.
5. American Academy of Pediatrics; Committee on Bioethics. Sterilization
of minors with developmental disabilities. Pediatrics 1999;104:337–40.
6. Neufeld JA, Klingbeil F, Nelson-Bryen D, Silverman B,Thomas A. Adolescent sexuality and disability. Phys Med Rehabil Clin N Am 2002;13:
857–73.
7. Schwartz JL, Creinin MD, Pymar HC.The tri-monthly combination oral
DEPOT MEDROXYPROGESTERONE ACETATE
Use of DMPA should be considered if oral medications are not
well tolerated or are contraindicated. However, the potential for
a reduction in bone mineral density12 and an increase in
weight13 with this treatment may not be desirable. If a woman’s
family requests a hysterectomy for hygiene purposes, use of
DMPA provides a good long-term alternative for management
when it is well tolerated.
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8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
NATURAL FAMILY PLANNING
contraceptive regimen: is it cost-effective? Contraception 1999;60:
263–7.
Cachrimanidou AC, Hellberg D, Nilsson S,Waldenstrom U, Olsson SE,
Sikstrom B. Long-interval treatment regimen with desogestrel-containing oral contraceptive. Contraception 1993;48:205–16.
Rutter W, Knight C,Vizzard J, Mira M, Abraham S.Women’s attitudes to
withdrawal bleeding and their knowledge and beliefs about the oral
contraceptive pill. Med J Aust 1988;149:417–9.
Gaber TA, Kirker SG, Jenner JR. Current practice of prophylactic anticoagulation in Guillain-Barre syndrome. Clin Rehabil 2002;16(2):190–3.
Hatcher RA,Trussell J, Stewart F, Cates W, Stewart GK, Guest F, et al.,
editors. Contraceptive technology. 17th ed. New York, NY: Ardent
Media; 1998.
Gbolade B, Ellis S, Murby B, Randall S, Kirkman R. Bone density in longterm users of depot medroxyprogesterone acetate. Br J Obstet
Gynaecol 1998;105:790–4.
Moore LL,Valuck R, McDougall C, Fink W. A comparative study of oneyear weight gain among users of medroxyprogesterone acetate,
levonorgestrel implants, and oral contraceptives. Contraception
1995;52:215–9.
Luukkainen T.The levonorgestrel intrauterine system: therapeutic
aspects. Steroids 2000;65:699–702.
Zurawin R, Paransky OI.The role of surgical techniques in the
treatment of menstrual problems and as contraception in adolescents
with disabilities. J Ped Adol Gynecol 2003;16:51–4.
Barrington JW, Bowens-Simpkins P. The levonorgestrel intrauterine
system in the management of menorrhagia. Br J Obstet Gynaecol
1997;104:614–6.
Wingfield M, McClure N, Mamers PM,Weigall DT, Paterson PJ, Healy DL.
Endometrial ablation: an option for the management of menstrual problems in the intellectually disabled. Med J Aust 1994;160:533–6.
Natural methods of contraception include abstinence, coitus
interruptus, and the application of fertility awareness for the
timing of coitus.
Abstinence as a choice for contraception is unlikely to be a
widely applicable option to reduce the incidence of unplanned
pregnancy, given that it requires a continuous exertion of will
against instinct. There is considerable political will, particularly in the United States, to validate abstinence as an appropriate
sexual behaviour for young unmarried men and women, and
federal funding has been provided to “market” the idea —
although not without concern expressed by human rights
groups.1 Nevertheless, in California, a large randomized study
of strategies designed to enhance postponement of sexual
involvement showed no benefit; paradoxically, they even showed
potential for encouraging sexual involvement.2
Fertility awareness is based on knowledge of both male and
female reproduction and on a reliable ability to predict ovulation. Traditionally, predicting ovulation has been based on
symptoms, basal body temperature recordings, and the calendar. More recently, electronic hand-held devices have recorded
information about temperature and menstrual cycle characteristics in order to predict the fertile time and alert women to the
need for abstinence or the use of barrier methods of contraception. There are many kits available for predicting ovulation
through detection of increased urinary LH excretion, but the
range of prediction is only 12–24 hours — insufficient to allow
prevention of conception. The Persona kit offers women a home
monitoring system to measure urinary estrone-3-glucuronide
as well as LH in order to predict, more remotely, the fertile time
of the cycle.3
CHAPTER 12:THE FUTURE OF CONTRACEPTION
Timothy Rowe, MB, FRCSC
Vancouver BC
INTRODUCTION
Control of fertility is now an assumed fact of life for many people living in industrialized countries. The current generation of
women in the reproductive age group has, for the most part,
grown up with the assumption that they can have the families
that they want, when they want. There is a trend towards later
childbearing, with at least 20% of Canadian women having
their first child after age 35. Thus, a growing number of women
spend decades using contraception, much of which is intrusive,
messy, or associated with side effects.
Contraception ideally should be simple, inexpensive, readily available, highly effective, entirely safe, free of any symptoms
or adverse effects, immediately reversible, and coitally independent. In addition, since it is used mostly by healthy young
women, contraception should confer some health benefit as an
incentive for consistent use. Of the currently available approaches in Canada, hormonal contraception for women in one form
or another comes closest to the ideal; but there are many women
for whom no ideal contraceptive exists. Refinements of current
approaches, or new approaches, to the prevention of fertilization or implantation are still needed.
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BARRIER METHODS
These include condoms, spermicides, diaphragms, and cervical
occlusive devices. The potential for improvement in the design
or applicability of the last two categories is limited, although
improving these options remains desirable.
Spermicides tend to irritate the vagina, because their spermicidal action relies on a detergent effect on sperm which also
affects the vaginal flora. Future spermicides may focus on a
mode of action that interferes instead with the acrosome reaction of sperm, and does not affect the vaginal flora. A promising candidate with these properties is cellulose sulfate, which
has shown less genital irritation than nonoxynol-9 while still
providing antifertility and antimicrobial effects.4 Spermicides
that coincidentally have antiviral properties are highly desirable
in the era of the human immunodeficiency virus (HIV); unfortunately, a prospective study of a nonoxynol-9 gel (COL-1492)
did not demonstrate protection against HIV transmission in
high-risk women.5 The search for suitable agents continues.
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several preparations containing new progestins (e.g., dienogest,
drospirenone, chlormadinone acetate) are available in Europe
and may be released in Canada in the future. The newer progestins carry individual potential metabolic advantages over currently available progestins.14,15
It is unclear whether or not the dose of estrogen can be further reduced. The use of oral contraceptives by older women
will likely continue to expand, particularly to control perimenopausal symptoms, and expansion of use into the postmenopausal years has great potential.
Most future advances in hormonal contraception for
females will involve improvements in methods of administration. Once-a-month oral contraceptive preparations have been
available for some time in China, using a powdered preparation
at the time of menstruation to suppress ovulation in the subsequent cycle.16 Another approach, less successful, has been to
administer a preparation that causes luteolysis and induction of
menses. Mifepristone administered once per month has been
proposed as an example of this kind of contraceptive; this would
appeal to women having sporadic intercourse.17
Another approach in attempting to provide estrogen-free
hormonal contraception has been to administer sequentially an
antiprogestin (mifepristone) followed by a progestin (nomegestrol acetate); this treatment combination results in inhibition of ovulation and the development of an irregular secretory
endometrium. Use of this combination has reached the stage of
phase II trials.18
Routes of hormone administration other than oral have
potential for development. The use of depot injections such as
Depo-Provera for contraception in Canada is a recent innovation by global standards, and its ultimate level of use in Canada is still unknown. Contraceptive implants releasing either
estrogen and progestin or progestin alone are slow to develop,
test, and market, and none are currently available in the Canadian market. (Sales of Norplant, the only implant to have been
marketed in Canada, were discontinued in September 2002.)
Second-generation implant systems (Implanon and Jadelle) have
been developed to simplify insertion and removal, with use of
1 or 2 rods respectively in place of Norplant’s 6. (See Chapter
5’s section on progestin-only hormonal contraception.)
Implanon releases etonogestrel for reliable contraception over a
span of 2 years, while Jadelle releases levonorgestrel with reliable contraceptive effect over 3 years (and is under FDA review
as a 5-year contraceptive).19 Another system undergoing trials
releases a different progestin, nestorone, from silastic implants;
this may be used safely in lactating mothers, since nestorone is
rapidly metabolized after oral administration and has no apparent effect if ingested by a baby in breast milk.20
Progestin implants and depot injections are, however, all
associated with irregular menstrual bleeding and the potential
for changes in weight and mood. Bleeding patterns tend to be
more predictable and amenorrhea less common with use of
Condoms will continue to be a mainstay of contraception
and strategies to prevent sexually transmitted infections (STIs).
New condoms made from strong, thin polyurethane and other
new polymers should provide better sensitivity and less potential for allergic reactions — which is one of the major concerns
with currently available latex condoms. (See Chapter 8,
“1. Condoms.”) These new condoms would also be less prone
to degradation by lubricants.
Attempts to promote the female condom as a mainstream
contraceptive have been relatively unsuccessful.6 It provides
women with protection against STIs, but it has little aesthetic
appeal and because of this will require refinement to become
more popular.
INTRAUTERINE DEVICES
The perceived association of intrauterine devices (IUDs) with
pelvic inflammatory disease (PID) has led to a steady reduction
in IUD use in North America.7 This perception will be difficult to reverse, despite the realization that the risk of PID is associated only with insertion of the device.8 (See Chapter 7.)
Nevertheless, the appeal of the IUD remains: it is highly effective, requires no maintenance, and now can be left in place for
at least 5 years. The longer duration of placement reduces the
risks of insertion (infection and perforation). The risk of expulsion may be reduced by new frameless and flexible devices
which are fixed into the myometrium, and with these devices
the potential for cramps and excess bleeding is also reduced.9
Hormone-releasing devices, particularly those releasing levonorgestrel (e.g., Mirena), provide reliable contraception with
a dramatic reduction in menstrual bleeding.10 They offer potential for therapeutic applications beyond contraception. Despite
this, liability issues (while not major concerns for modern IUDs)
make industry cautious about becoming involved in this area
of contraception. These concerns discourage companies from
revising product labels containing highly conservative warnings
about IUD use. This conservative product labeling discourages
physicians from recommending use of an IUD.11
HORMONAL CONTRACEPTION
FEMALE HORMONAL CONTRACEPTION
Developments in oral contraception have led to a steady reduction in the daily dose of both estrogen and progestin and the
development of progestins with reduced metabolic impact.
Third-generation progestins were introduced with the aim of
reducing arterial disease in women,12 but the large-scale acceptance of preparations containing these progestins has been
affected by the controversy over whether or not they carry a
higher risk of venous thrombosis than older preparations.13 (See
Chapters 4 and 6.) This controversy has to some extent discouraged the release of new oral contraceptive preparations; but
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combined estrogen-progestin preparations such as Lunelle,21
although the inclusion of estrogen requires the same medical
considerations as the use of combined oral contraceptives.
Future possibilities for administration of contraceptive
steroids include the use of injectable microspheres containing both
estrogen and progestin22 and further development of vaginal
rings and transdermal patches delivering low doses of estrogen
and progestin. Each of these would offer better control of vaginal bleeding and theoretically superior compliance.
production of antibodies to HCG have been under investigation for several decades.
Fertilization-limiting vaccines under investigation are directed either against sperm surface antigens or against the zona pellucida. The idea of inducing antibodies in women against sperm
is an old one; in 1932, Baskin produced “temporary sterilization” in women by injecting them with their husband’s sperm.27
Investigations related to this approach did not continue. However, research to identify specific sperm surface antigens that
could be the basis for a fertility-regulating vaccine in males or
females has continued, and two of these (FA-1 and YLP(12))
show particular promise.28 Sperm surface antibodies are able to
affect sperm either before they leave the male or when they reach
the female, but only a small proportion of the sperm generated
in the male ever reach the site of fertilization in the female. Antibodies generated in the female therefore have to deal with significantly less sperm than do antibodies generated in the male.
Thus antisperm vaccines appear to have more potential for
effectiveness in females than in males.29
The vaccines stimulating antibody production against the
zona pellucida have the undesirable effect of causing oophoritis or ovarian failure through depletion of primordial follicles
from the ovary.30 Attempts to identify epitopes (specific antigenic determinants) that might allow a contraceptive effect of
such a vaccine without causing pathological effects within the
ovary are continuing.
Research carried out in India under the auspices of the
World Health Organization (WHO) in the 1970s resulted in
the development of a vaccine stimulating the production of
antibodies to the β-subunit of the human chorionic
gonadotropin (HCG) molecule (and, through linkage of antigens, coincidentally to Clostridium tetani).31 Because of potential cross-reactivity with LH, the WHO has sponsored research
using an antibody to a 37-amino acid section of the β-HCG
subunit in order to minimize the risk of autoimmune damage
to pituitary cells.29 These antibodies are only effective for a few
months and thus require frequent repeat immunizations. However, there has been no evidence of autoimmune damage to
pituitary cells, even where antibodies to the entire β-subunit of
HCG are generated; but there has been some evidence of unexpected cross-reactivity against pancreatic and pituitary cells with
antibodies raised against the carboxyl terminal of the β-subunit.
Long-term studies will be needed to learn whether this finding
is clinically significant.29
There is political opposition to the development of β-HCG
vaccines for contraception, since they could be considered
abortifacient.32 The developers maintain that, in human studies, the length of the menstrual cycle has been unaffected by the
development of anti-β-HCG antibodies, and that their effect
occurs before the completion of implantation.33 There is similarity to the concerns that have been expressed by some about
the mode of action of intrauterine devices.
MALE HORMONAL CONTRACEPTION
Regrettably, there does not appear to be a bright future for the
development of reliable and acceptable means of contraception
directed at suppression of sperm production. An agent which
will easily, safely, and reliably suppress sperm production
while leaving libido and erectile function intact has yet to be
developed.
Weekly injections of testosterone will induce oligo- or
azospermia after 3 months of treatment, but may be associated
with acne, mood change, adverse lipoprotein changes, and delay
in return of fertility.23 The need for weekly injections and the
potential for delay in return of fertility limit the appeal of this
method. The addition of a progestin may allow the use of lower
doses of testosterone, but the approach is not universally effective. Long-acting testosterone esters, delayed-release pellets of
testosterone and implants of androgen or progestin are being
explored as possible avenues for acceptable delivery of
steroids.24,25
An alternative approach in males is the use of a GnRH agonist to suppress testicular function combined with androgen
therapy to maintain libido and male habitus and sexual characteristics. This has not proven as successful as hoped,26 and the
expense of such an approach makes it an impractical option.
IMMUNOLOGICAL APPROACHES
The idea of using the induction of antibodies to components
of the reproductive process for contraception has been pursued
for more than 30 years. While there have been promising
achievements in animal and some human studies, there is a need
for considerable refinement of the approach before it can
become a practical option for widespread use. The ideal vaccine
for contraception should be safe and reliable; furthermore, in
order to be widely acceptable it should produce a long-lasting
effect and should be reversible.
FEMALE IMMUNOLOGICAL APPROACHES
Research in immunocontraception is currently focused upon
two areas of reproduction in the female: fertilization and maternal recognition of pregnancy. Producing a vaccine that will interfere with fertilization is limited by our understanding of the
molecular mechanisms involved, but vaccines stimulating
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cytotrophoblasts at the fetal-maternal interface. These circulating antigens have a capacity analogous to that of membranebound structures to inhibit natural killer (NK) cells. 39
Interference with the production or action of the HLA-G antigens would result in the establishment of an immune response
to the conceptus, involving NK cells.
MALE IMMUNOLOGICAL APPROACHES
Developing antibodies against GnRH or FSH to suppress
sperm production has been shown to be possible.34 However,
the use of suppressive therapy with androgens has been a more
practical approach to the induction of reversible oligo- or
azospermia, since it avoids the possibility of systemic immune
reactions.
Raising antibodies to sperm surface proteins should allow
sperm production to continue, but the sperm subsequently
would either be immobilized or rendered incapable of fertilization. However, developing antibodies to sperm proteins carries
a risk of stimulating testicular inflammation.29 In addition, as
described above, such antibodies would need to bind to the surface of considerably more sperm in the male genital tract than
at the site of fertilization in the female. Nevertheless, the characterization of human sperm surface antigens is in its infancy,35
and it may prove possible to develop vaccines generating
immune responses in the epididymis or secondary sexual glands
that are sufficient to have a contraceptive effect.
REFERENCES
1. Human Rights Watch.Vol. 14, No. 5 (September 2002). Available on-line
at <http://www.hrw.org/reports/2002/usa0902>. Accessed February 5,
2003.
2. Kirby D, Korpi M, Barth RP, Cagampang HH.The impact of the postponing sexual involvement curriculum among youths in California. Fam Plann
Perspect 1997;29:100–8.
3. Bonnar J, Flynn A, Freundl G, Kirkman R, Royston R, Snowden R.
Personal hormone monitoring for contraception. Br J Fam Plann
1999;24:128–34.
4. Mauck C,Weiner DH, Ballagh S, Creinin M, Archer DF, Schwartz J,
et al. Single and multiple exposure tolerance study of cellulose sulfate
gel: a phase I safety and colposcopy study. Contraception 2001;64:
383–91.
5. Van Damme L, Ramjee G, Alary M,Vuylsteke B, Chandeying V, Rees H,
et al; COL-1492 Study Group. Effectiveness of COL-1492, a nonoxynol-9 vaginal gel, on HIV-1 transmission in female sex workers: a
randomised controlled trial. Lancet 2002;360:971–7.
6. Latka M. Female-initiated barrier methods for the prevention of
STI/HIV: where are we now? where should we go? J Urban Health
2001;78:571–80.
7. Fisher WA, Boroditsky R, Bridges ML.The 1998 Canadian contraception
study. Can J Hum Sex 1999;8:161–216.
8. Farley TM, Rosenberg MJ, Rowe PJ, Chen JH, Meirik O. Intrauterine
devices and pelvic inflammatory disease: an international perspective.
Lancet 1992;339:785–8.
9. Anonymous. FDA approval sought for frameless, flexible IUD. Contracept Technol Update 1999;20:41–2.
10. Ronnerdag M, Odlind V. Health effects of long-term use of the
intrauterine levonorgestrel-releasing system: a follow-up study over 12
years of continuous use. Acta Obstet Gynecol Scand 1999;78:716–21.
11. Rivera R and Best K. Consensus statement on intrauterine contraception. Contraception 2002;65:385–8.
12. Anonymous. New progestins focus on eliminating side effects. Contracept Technol Update 1988;9:50–1.
13. Kemmeren JM, Algra A, Grobbee DE.Third generation oral contraceptives and risk of venous thrombosis: meta-analysis. BMJ 2001;323:1–9.
14. Ho PC,Yu Ng EH,Tang OS. Mifepristone: contraceptive and noncontraceptive uses. Curr Opin Obstet Gynecol 2002;14:325–30.
15. Rowlands S. Newer progestogens. J Fam Plann Reprod Health Care
2003;29:13–6.
16. Xiao B,Wang M. Birth control techniques in China. China Popul Newsl
1983;1:1–7.
17. Schramm G, Steffens D. A 12-month evaluation of the CMA-containing
oral contraceptive Belara: efficacy, tolerability and anti-androgenic properties. Contraception 2003;67:305–12.
18. Croxatto HB, Salvatierra AM, Fuentealba B, Massai R. Contraceptive
potential of a mifepristone-nomegestrol acetate sequential regimen in
women. Hum Reprod 1998;13:3297–302.
19. Meirik O, Fraser IS, d’Arcangues C;WHO Consultation on Implantable
Contraceptives for Women. Implantable contraceptives for women.
Hum Reprod Update 2003;9:49–59.
20. Sivin I, Moo-Young A. Recent developments in contraceptive implants at
the Population Council. Contraception 2002;65:113–9.
21. World Health Organization Task Force on Long-Acting Systemic Agents
for Fertility Regulation. A multicentred phase III comparative study of
two hormonal contraceptive preparations given once-a-month by
NEW APPROACHES TO CONTRACEPTION
ANTITESTICULAR AGENTS
Lonidamine is an indazole carboxylic acid compound used in
cancer treatment. Its development as an antispermatogenic contraceptive compound in the early 1980s was abandoned because
of renal damage, but recent derivatives have shown efficacy and
reversibility as contraceptive agents in animal studies, without
toxicity in either the liver or kidney.36 They have no effect on
the hypothalamic-pituitary-testicular axis; their effect in the
testis arises from their ability to cause germ-cell loss from the
seminiferous epithelium. Human studies of these compounds
have yet to begin.36
ANTI-IMPLANTATION STRATEGIES
Besides the generation of antibodies to β-HCG, strategies to
stimulate interference with key steps in implantation are being
explored. These key steps include angiogenesis and protection
of the conceptus from immune responses.
Fumagillin is an anti-angiogenic agent that has shown some
ability to prevent implantation when administered vaginally in
monkey studies.37 No human studies have been conducted, and
appear unlikely to occur until further evidence of anti-nidatory
effectiveness is available.
The peptide pre-implantation factor (PIF) is one of the earliest known signals for the recognition of pregnancy; it appears
to be produced even by 2-cell embryos.38 Its exact role in
implantation is unknown, but theoretically an analog of such a
peptide could be used to interfere with maternal recognition of
a conceptus, with consequent failure of implantation. Another
fundamental requirement for the establishment of a pregnancy
is the secretion of HLA-G antigens, produced primarily by
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22.
23.
24.
25.
26.
27.
28.
29.
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