Download The Management of Vaginal Atrophy: A Primer for Pharmacists

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A CONTINUING EDUCATION LESSON • 1.5 CEUs
Approved for 1.5 CE Units
Approved for 1.5 CE units
by the Canadian Council
on Continuing Education in
Pharmacy. File # 189-1104
Objectives:
Upon successful completion of this
lesson, you should be able to:
1. Identify the signs and symptoms of
vaginal atrophy.
2. Discuss the nonpharmacologic and
pharmacologic options for the treatment of vaginal atrophy.
3. Review the benefits and risks with
each of the options for the treatment of
vaginal atrophy.
4. Understand the pharmacist’s role in
the management of vaginal atrophy.
Author:
Nese Yuksel is a clinical pharmacist
with the Mature Women’s Clinic and
the Osteoporosis Clinic at the Grey
Nuns Hospital in Edmonton. She is also
an associate professor at the Faculty of
Pharmacy and Pharmaceutical Sciences
at the University of Alberta. Nese has
presented numerous times on the topics
of menopause, hormone replacement
therapy, and symptom management in
perimenopause and menopause.
Instructions:
1. After carefully reading this lesson,
study each question and select the one
answer you believe to be correct.
Circle the appropriate letter on the
attached reply card.
2. Complete the card and mail, or fax
to (416) 764-3937.
3. Your reply card will be marked and
you will be advised of your results in a
letter from Rogers Publishing.
4. To pass this lesson, a grade of 70%
(14 out of 20) is required. If you pass,
your CEU(s) will be recorded with the
relevant provincial authority(ies).
(Note: some provinces require individual pharmacists to notify them.)
The Management of
Vaginal Atrophy:
A Primer for Pharmacists
By Nese Yuksel, BScPharm, Pharm D
The author, expert reviewers and Pharmacy Practice magazine have each declared that
there is no real or perceived conflict of interest with the sponsor company.
Introduction
Vaginal atrophy is a common condition
that affects up to 50% of postmenopausal women.1 Vaginal atrophy is
defined as a deterioration in urogenital
tissue from both vaginal tissue aging and
lack of estrogen.1,2 Other terms for vaginal atrophy include atrophic vaginitis
and urogenital atrophy. The most common cause of vaginal atrophy is a decline
in estrogen levels with menopause.
Other causes include oopherectomy,
postpartum loss of placental estrogen,
breast-feeding, radiation, chemotherapy,
and certain medications such as
gonadotrophin-releasing (GnRH) agonist analogues (e.g. leuprolide, naferelin), danazol, tamoxifen, medroxyprogesterone, and anticholinergics.3 Since
smoking can increase the metabolism of
estrogens, smokers may see an earlier
occurrence and more severe symptoms of
vaginal atrophy.4
Many women do not feel comfortable
discussing symptoms of vaginal atrophy
with their physician or other health-care
professionals. In fact, only 25% of
women with symptoms will seek treatment.5 Pharmacists need to be aware of
the consequences associated with vaginal
atrophy as it can have a negative impact
on urogenital health and a woman’s sex-
uality. Symptoms of vaginal atrophy can
be uncomfortable and irritating. In
patients with severe symptoms such as
dyspareunia, normal sexual health can be
adversely affected. It can lead to a loss of
sexual interest and a decrease in selfesteem, potentially affecting a woman’s
relationship with her partner.6,7 All of
these factors can impact quality of life.6
The Society of Obstetrics and
Gynecology of Canada (SOGC) has
recently developed Clinical Practice
Guidelines for the Detection and
Management of Vaginal Atrophy.1 These
evidence-based guidelines were developed to support practitioners in the care
of women with symptoms of vaginal
atrophy. This lesson focuses on the treatment approaches for vaginal atrophy and
highlights the new SOGC clinical practice guidelines.
Pathophysiology
Estrogen is the primary hormone responsible for maintaining vaginal health.
Estrogen receptors exist throughout the
vagina, bladder, urethra, and pelvis.1
Other hormone receptors include progesterone receptors in the vagina, and androgen receptors in the vagina and suprapubic tissue.3 A number of physiologic
changes in the vagina are seen with
Supported by an educational grant from
This CE lesson is published by Rogers Media
Healthcare/Sante, One Mount Pleasant Rd., Toronto,
Ont., M4Y 2Y5. Tel.: (416) 764-3916 Fax: (416) 764-3931.
No part of this CE lesson may be reproduced, in whole
or in part, without the written permission of the publisher.
February 2005
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declining estrogen levels. The vaginal
epithelium becomes thinner, atrophies
and loses its rugal folds. Further changes
include fragmentation of elastic fibers and
degeneration of connective tissue, resulting in vagina narrowing and loss of elasticity. Blood flow to the vagina is reduced
and normal vaginal secretion decrease. All
of these changes contribute to vaginal
dryness, loss of normal lubrication, and
dyspareunia.
The decline in estrogen concentrations also impacts urinary function.
Normal vaginal pH is kept acidic (pH of
3.5 to 4.5) from the conversion of glycogen (from shed epithelial cells) to lactic
acid by vaginal lactobacilli.5 The cellular
thinning of the vaginal epithelium with
declining estrogen levels reduces the
amount of glycogen available, diminishing lactobacilli growth and increasing
vaginal pH. Normal vaginal flora is
altered leading to an increased susceptibility to vaginal and urinary tract infections. Further urogenital changes, such
as thinning urethral lining, weakening
bladder muscles, and atrophy of the
mucosal layer of the bladder, predisposes
a woman to urinary urgency, frequency
and incontinence.5,8
Symptoms
A decrease in vaginal lubrication is one
of the earliest changes seen with vaginal
atrophy. As vaginal atrophy progresses,
symptoms include vaginal dryness,
burning, itching, pressure, malodorous
discharge and loss of vaginal secretions.
Not all women will experience symptoms and the intensity of the symptoms
can vary between individuals. The prevalence of vaginal dryness has been reported to range up to 55% of postmenopausal women.7,9 It has also been
estimated that close to 40% of women
who are taking oral hormone replacement therapy may continue to have vaginal dryness.1,10
Normal sexual function can be significantly affected during this time.
Inadequate vaginal lubrication during
sexual intercourse can cause dyspareunia,
which has been reported in up to 41%
of post-menopausal women.7 In some
patients, vaginal atrophy can be severe
enough to cause post-coital bleeding and
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vaginismus (painful spasm of vaginal
muscles).1 A woman may experience anxiety with the expectation of pain on intercourse, and begin to avoid sexual intercourse. In addition, both a decrease in
estrogen and androgen levels can lead to
difficulties in sexual arousal and a lowered
libido.11 Sexual dysfunction is multifactorial. However, all of these factors can play
a part in interfering with a woman’s relationships with her partner.6,11
Common urinary symptoms associated with vaginal atrophy include urinary
urgency, frequency, stress incontinence
and recurrent urinary tract infections.
Management Options
The options for the management of vaginal atrophy are dependent on the needs of
the specific patient. Therapy should be
convenient and simple to use.12
LIFESTYLE MODIFICATIONS
It is important to identify all reversible
causes of vaginal atrophy. Obtaining a
good history of when symptoms started
in relation to precipitating factors may
help in recognizing potential causes.
Wherever possible, drugs that may have
contributed should be discontinued, and
exposure to any sensitizing chemicals (e.g.
douches, perfumed products, etc) avoided. Since smoking increases the metabolism of estrogen and may worsen vaginal
atrophy, women should be encouraged to
stop smoking.1 Regular sexual activity can
help maintain vaginal health in postmenopausal women. Sexual activity stimulates blood flow to the vagina. This
increases vaginal secretions and maintains
vaginal elasticity. Masturbation also has
similar benefits.13 Cranberry juice has
been traditionally used to prevent urinary
tract infections, however, a recent
Cochrane Review found no concluding
evidence that cranberry juice decreases
the risk of urinary tract infections.14
Instead, the SOGC Clinical Practice
Guidelines recommend the use of the
combination of cranberry-lingonberry
juice in women who experience recurrent
urinary tract infections (See Table 1).1
This recommendation is based on an
open label, randomized controlled trial,
which found the daily use of a cranberrylingonberry concentrate for six months
reduced the risk of urinary tract infections
by 20% as compared to placebo.15
NON-HORMONAL OPTIONS
Non-hormonal options for vaginal atrophy include vaginal moisturizers and
lubricants. Often considered as alternatives to hormone replacement therapy
(HT), both moisturizers and lubricants
can be used in conjunction with HT as
well. Replens™, a vaginal moisturizer,
is a bioadhesive, polycarbophil-based
polymer that attaches to mucin and
epithelial cells in the vaginal wall. The
polymer attracts water, maintains it close
to the epithelial surface of the vagina and
produces a moist film over the vaginal
wall.16 Regular use of the polymer can
help with symptoms of vaginal atrophy
such as vaginal dryness and dyspareunia.
The use of Replens™ three times weekly was found to have equivalent efficacy
to conjugated estrogen (CE) vaginal
cream 1.25 mg/day in improving symptoms of vaginal atrophy and decreasing
vaginal pH.17 Replens™ is applied
intravaginally with a disposable, prefilled
applicator. Replens™ should be used
every three days, and does not need to be
repeated prior to intercourse.
In comparison, vaginal lubricants
(i.e. Astroglide™, KY Jelly™) have a
short duration of action and should be
applied right before sexual intercourse.
Most of these agents come in a watersoluble base and are made of a combination of protectants and thickening
agents.3 These agents help with the irritation that occurs with intercourse.1
A variety of herbal therapies have
been suggested in the lay press to help
with vaginal dryness and dyspareunia.
These include phytoestrogens, black
cohosh, chaste tree, dong quai and wild
yam creams. There is no evidence to support chaste tree or wild yam creams.
Studies with dong quai as monotherapy
have shown no benefit.18 Studies with
black cohosh and phytoestrogens are
inconclusive.3
HORMONE THERAPY
EFFICACY
Vaginal Atrophy
In women who have no contraindications to HT, estrogen is the mainstay of
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TABLE 1: Recommendations from the SOGC Clinical Practice Guidelines for
the Management of Vaginal Atrophy.1
Lifestyle Modifications
1. Regular sexual activity should be encouraged to maintain vaginal health (II-2B)
2. Women experiencing recurrent urinary tract infections should be instructed
that consumption of pure cranberry-lingonberry juice, rather than cranberry
juice, will decrease their risk of urinary tract infections. (I-A)*
Vaginal Moisturizers
1. Vaginal moisturizers applied on a regular basis have an efficacy equivalent to
local hormone replacement for the treatment of local, urogenital symptoms
such as vaginal itching, irritation and dyspareunia, and should be offered to
women wishing to avoid use of hormone replacement therapy. (I-A)
Hormone Therapy
1. Women experiencing vaginal atrophy can be offered any of the following
effective vaginal estrogen replacement therapy: conjugated estrogen (I-A),
a sustained-release intravaginal estradiol ring (I-A), or a low-dose estradiol
tablet. (I-A)
2. Although systemic absorption of estrogen can occur with local preparations,
there is insufficient data to recommend annual endometrial surveillance in
asymptomatic women using local estrogens. (III-C)
Treatment of Urinary Tract Infections
1. For menopausal women experiencing recurrent urinary tract infections and
who have no contraindications to local hormone replacement, vaginal
estrogen therapy should be offered. (I-A)
The information provided in the brackets refers to the quality of the evidence
rated using the criteria described by the Canadian Task Force on the Periodic
Health Examination (Table 1A)
TABLE 1A: Evaluation of Evidence Criteria and Classification of
Recommendations Used in the SOGC Clinical Practice Guidelines1
Level of Evidence
Classification of Recommendation
I
A
There is good evidence to support the
recommendation that the condition
be specifically considered in a
periodic health examination.
II-1 Evidence from well-designed
controlled trials without
randomization.
B
There is fair evidence to support the
recommendation that the condition
be specifically considered in a
periodic health examination.
II-2 Evidence obtained from welldesigned cohort (prospective or
retrospective) or case-control
studies, preferably from more
than one centre or research
group.
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.
II-3 Evidence obtained from comparison between times or places
with or without intervention.
Dramatic results in uncontrolled
experiments can also be
included in this category.
D
There is fair evidence to support the
recommendation that the condition
not be considered in a periodic
health examination.
III
E
There is good evidence to support
the recommendation that the condition be excluded from consideration
in a periodic health examination.
Evidence obtained from at least
one properly randomized
clinical trial.
Opinions of respected authorities, based on clinical experience, descriptive studies, or
reports of expert committees.
February 2005
therapy for vaginal atrophy. Estrogens
have been shown to have an overall beneficial effect on urogenital health.
Estrogens enhance blood flow to the
vagina, boost vaginal mucosal maturation, thicken vaginal mucus, and
increase secretions.3,11,19 A number of
routes of administration are available for
HT including oral, transdermal and
intravaginal. All routes of administration
have been found to be effective for the
treatment of vaginal atrophy.20 A recent
systematic review of 16 trials involving
intravaginal estrogens concluded that
vaginal conjugated estrogen (CE) cream,
vaginal estradiol tablets and estradiol
vaginal ring were equally effective.21
Urinary Tract Infections
Estrogens restore normal vaginal acidic
pH. This helps increase the proportion
of lactobacilli, and potentially reduce the
risk of urinary tract infections (UTIs).
Intravaginal estrogen has been shown to
decrease the rate of recurrent urinary
tract infections.22-24 Trials with the estradiol ring,22 intravaginal estradiol tablet,23
and estriol cream24 have all demonstrated
a lower incidence of urinary tract infections as compared to placebo. Information on the efficacy of systemic estrogens
on the incidence of urinary tract infections is lacking.25 In the Heart and
Estrogen/Progestin Replacement Study
(HERS), the combination of oral estrogen and progestin (0.625 mg CE and
2.5 mg medroxyprogesterone) did not
reduce the risk of UTI.26
Urinary Incontinence
The role of estrogens for urinary incontinence is controversial. A meta-analysis
of estrogens used in urinary incontinence showed a subjective but not objective benefit in patients with stress incontinence.27 However, since this publication, randomized controlled trials with
oral estrogens for the treatment of stress
incontinence have showed no improvement of estrogen replacement therapy
over placebo.28 The information on
estrogens and urge incontinence is also
difficult to interpret. A recent Cochrane
Review suggested that estrogen therapy
may improve urge incontinence, however,
it is difficult to make a conclusion
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because of the small sample sizes in the
trials and the inconsistency in estrogen
products, dosages and durations.29
Several recent studies have also suggested
that oral and transdermal estrogens, with
or without progestin, may increase
development of urinary incontinence.29-31
The role of HT in the treatment of urinary incontinence remains unclear.
PRODUCT CHOICES
Systemic Estrogens
Since the publication of the Women’s
Health Initiative (WHI), there has been
a great deal of controversy regarding the
risks and benefits of oral hormone therapy.32 The estrogen and progestin arm of
the WHI was stopped early in July 2002
because the increased risks of non-fatal
MIs, venous thromboembolism, stroke
and breast cancer with combined CE
0.625 mg and medroxyprogesterone 2.5
mg daily, outweighed the potential benefits of reducing the risk of fractures and
colorectal cancer.33 The WHI was
designed to assess the prevention of
chronic diseases (primarily of coronary
heart disease) with HT. More recently,
the estrogen-alone portion of the WHI
was halted in March 2004 after close to
7 years were completed of the planned 8year follow-up.34 The study was stopped
early because the investigators felt there
was sufficient data to assess the risks and
benefits of estrogen, and that the study
results would not be altered with one
more year of data. Estrogen-alone therapy
had no effect on coronary heart disease
(nonfatal MIs or CHD death), which
was the primary outcome. The risk of
breast cancer was reduced by 23% in the
estrogen-alone arm, however this was
not statistically significant. There was an
increased risk of stoke by 39% (absolute
increased risk of 12 strokes per 10,000
women-years), and increased risk of
deep vein thrombosis (DVT) by 33%
(absolute increased risk of 7 DVT per
10,000 women-years). A decreased risk
of hip fractures by 39% (absolute
decreased risk of 6 hip fractures per
10,000 women-years) and vertebral fractures by 38% (absolute decreased risk of
6 vertebral fractures per 10,000 womenyears) were also statistically significant.35
There was no effect on the risk of colCE 4
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TABLE 2: Vaginal Estrogen Products Available in Canada
Estrogen Preparation
Strengths
Administration
Conjugated estrogen
vaginal cream
(Premarin Cream™)
0.625 mg
per gram
0.5 gm (0.3 mg) daily for the first
14 days, and then 0.5 gm q
2 – 3 times weekly.
17 beta-estradiol vaginal tablet 25 µg
(Vagifem™)
1 tablet daily for the first 14 days,
and then 1 tablet twice weekly.
17 beta-estradiol vaginal ring
(Estring™)
1 ring every 90 days
2 mg
per ring
orectal cancer. The results of both arms
of the WHI has helped clarify that estrogen-alone therapy and the combination
of estrogen and progestin together
should not be used to prevent chronic
diseases such as coronary heart disease.
Recent position statements from the
SOGC36 and the North American
Menopause Society (NAMS)37 recommend HT for the treatment of moderate
to severe menopause symptoms such as
hot flushes, sleep disturbances and vaginal dryness. The position statement
from NAMS recommends avoiding
extrapolating the results from the WHI
to women younger than aged 50 years, as
these women were not studied in these
trials. In addition, NAMS recommends
extended use at the lowest effective dose
for women for whom the benefits outweigh the risks and who continue to
have symptoms after an attempt to withdraw the HT.37
Systemic estrogen therapy is an
option in women who are experiencing
symptoms of vaginal atrophy along with
other menopausal symptoms such as hot
flushes, night sweats, and sleep disturbances. A variety of systemic estrogen
products are available in Canada including oral tablets, transdermal patches and
transdermal gel. Women with an intact
uterus on systemic estrogens should also
be on progestin therapy to prevent
endometrial hyperplasia. The lowest
dose of systemic estrogens required to
relieve symptoms of vaginal atrophy is
not completely clear and likely should be
individualized to each woman. In one
study, an ultra-low-dose estrogen patch,
12.5 mg, was found to be more effective
than placebo in improving vaginal dryness.38 Some women on systemic estrogens may require co-administration with
an intravaginal estrogen product.
Common side effects of systemic hormone replacement therapy include
breast tenderness, fluid retention, nausea
and vaginal bleeding. Absolute contraindications to systemic estrogen therapy include unexplained vaginal bleeding, acute liver disease, active thromboembolism, and known or suspected
breast cancer.39
Vaginal Estrogen Products
With vaginal products, estrogen can be
given locally to the vaginal tissue at lower
doses (See Table 2). The latest position
statement from the North American
Menopause Society recommends that in
women who are considering HT solely
for the symptoms of vaginal atrophy, that
vaginal estrogens be considered.12,37
There may be systemic absorption of
estrogens with vaginal products, however
the circulating estrogen levels are very
low and therefore, associated with
insignificant systemic side effects. The
absorption of estrogen across the vagina
is higher at the start of treatment, however as the vaginal mucosa normalizes, less
absorption is seen.40 Side effects with the
vaginal estrogens are mild and include
vaginal spotting and discharge, vaginal
irritation and itching, and skin rash. It is
believed that vaginal products are safe
on the endometrial lining at the doses
currently recommended.1,25
Conjugated estrogen vaginal cream
Each gram of conjugated estrogen
(CE) vaginal cream (Premarin Vaginal
Cream™) contains 0.625 mg of conjugated estrogens. The efficacy of CE vaginal cream on improving vaginal atrophy
symptoms is well documented.41-43
Estrogen may be absorbed into the sysFebruary 2005
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temic circulation from the CE cream,
but the systemic absorption is dosedependent and minimal at the current
recommended doses (See Table 2).42,43
Dosages of the cream, as low as 0.3 mg
conjugated estrogen, have been shown to
be effective.43 Handa et al demonstrated
that 0.3 mg CE intravaginally daily for
14 days, and then followed by 3 times
weekly for 6 months, relieved symptoms
of vaginal atrophy and improved vaginal
cytology.43 There were no significant
increases in estrogen concentrations
from baseline and only one patient
developed endometrial proliferation.
Cases of endometrial hyperplasia have
been reported with studies using higher
doses of CE vaginal cream.44,45 Ten percent of patients on a 3-weeks-on and 1week-off cycle of 1.25 mg CE cream
daily had mild endometrial hyperplasia
after 12 weeks.44 Another study using
similar high doses of CE cream resulted
in 2 cases of endometrial hyperplasia and
7 cases of proliferative endometrium.45 A
study using lower dosages of CE cream
of 0.625 mg for 6 months found no
cases of endometrial proliferation by
ultrasound.46 There have been no reports
of endometrial cancer with CE cream.1
The SOGC Clinical Practice Guidelines
do not recommend the use of progestin
therapy or performing annual endometrial ultrasound or biopsies for women
using low doses of vaginal CE cream.1
The current recommended dose for
maintenance therapy is 0.3 mg CE
cream inserted intravaginally 2 to 3
times weekly. Women can start with an
initial dose of 0.3 mg daily for the first
14 days, and then switch to the maintenance dose. CE cream is applied with a
reusable plastic applicator. The easiest
way to administer is to have the patients
lie down with their knees bent, insert
the applicator deep into the vagina, and
then press the plunger of the applicator
to deliver the cream. The applicator and
plunger should be washed with warm,
soapy water and then rinsed well with
plain water. It is recommended to apply
the cream at bedtime, to avoid possible
leaking of the cream. A panty-liner may
be suggested to avoid staining of underwear. For external irritation or dryness, a
small amount of the CE cream can be
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applied to the outer skin folds of the
vagina.
Sustained-release vaginal estradiol ring
The sustained-release vaginal estradiol
ring (Estring™) is a flexible, silicone
ring containing 2 mg 17beta-estradiol in
the core. When placed in the vagina, the
ring delivers 7.5 µg 17beta-estradiol a
day for 12 weeks. The vaginal ring is
inserted into the upper third of the vagina vault and has the advantage of providing a uniform and sustained release of
estradiol directly to the vaginal tissue. In
studies, the ring has resulted in low systemic estrogen levels that have been similar to the baseline mean of postmenopausal women.47 The estradiol
vaginal ring has been shown to relieve
symptoms of vaginal atrophy48 and
decrease the occurrences of UTIs.22 In a
study by Ayton et al, the estradiol ring
had similar efficacy to CE cream 0.625
mg per day after 3 months of therapy.49
The most common side effects
reported with the ring are vaginal discomfort, irritation or ulceration, and
vaginal discharge. There have been no
reports of endometrial hyperplasia in
studies with the vaginal ring.47,48 The
vaginal ring can be inserted and removed
by most patients. Patients with limited
hand mobility, smaller vaginal capacity
or pelvic organ prolapse may have more
difficulty.1 It is suggested to press the
ring into an oval and insert as deep as
possible into the upper one-third of the
vaginal vault. To help with the insertion,
the patient can squat, lie down with
knees drawn up or stand on one leg with
the other leg raised. The ring is worn
continuously for 3 months, and does not
need to be removed with intercourse.
However, if the ring causes any discomfort for the woman or her partner, the
ring can be removed prior to intercourse.
If the ring is removed or falls out, it
should be washed with lukewarm water
and then reinserted. During treatment of
a vaginal infection, the ring should be
removed for the course of the treatment.
Intravaginal estradiol tablets
The most recent addition to the vaginal
estrogen market in Canada is the vaginal
estradiol tablet (Vagifem™). This sus-
tained-release vaginal tablet, containing
25 µg 17beta-estradiol per tablet, forms
a hydrophilic gel layer on the vagina,
which allows estradiol to diffuse into the
vaginal epithelium. The vaginal tablet
has been shown to improve vaginal dryness and dyspareunia50,51 without significant systemic estrogen absorption50,51 or
effects on the endometrial lining.45,50,51
The concentrations of estrogen that have
been observed with the tablet are within
the normal post-menopausal range.50,51
In an open label, randomized trial of 159
menopausal women, 25 µg 17beta-estradiol vaginal tablets twice weekly for 24
weeks, was equally effective to 1.25 mg
of CE cream in relieving the symptoms
of vaginal atrophy.45 Higher estradiol
concentrations were observed in the
patients using the CE cream compared
to the vaginal tablet, and only one
patient in the vaginal tablet group developed endometrial hyperplasia compared
to 2 women using the CE cream. It is
difficult to make any firm conclusions
with this study as higher doses of the
cream were used than what is currently
recommended.
The tablet is inserted intravaginally
into the upper vagina using a single dose,
disposable, prefilled applicator. One
tablet daily is inserted for the first 14
days, followed by 1 tablet twice a week
for maintenance.
Pharmacists’ Role
Pharmacists are in an ideal position to
assess patients for symptoms of vaginal
atrophy, and to educate patients on the
options for vaginal atrophy and the benefits and risks with each option. By being
aware of the many choices for delivery of
estrogen therapy, and the alternatives
available, a pharmacist can play an integral role in helping patients make indi-
Resources for Pharmacists
Society of Obstetricians and
Gynecologists of Canada
www.sogc.medical.org
North American Menopause Society
www.menopause.org
American College of Obstetricians
and Gynecologists
www.acog.org
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vidualized decisions. Pharmacists should
also remember to assess for any precipitating factors and recommend the discontinuation of any reversible causes. It
may be uncomfortable for some patients
to discuss symptoms of vaginal atrophy,
however by providing the right environment, that is comfortable for the patient
and open to discussion, will help alleviate some of the uneasiness. Patient counselling on the various estrogen products
should provide clear instructions on how
to administer the various products, and
details for expected outcomes and potential side effects. Patients who start on
estrogen therapy for vaginal atrophy may
see some improvement in symptoms
after one month; however it may take
up to a few months to see adequate
response. Patient follow-up should
include questions on response to therapy, assessment of compliance and any
adverse outcomes.
References
1. Johnston SL, Farrell SA, Bouchard C et al. The
detection and management of vaginal atrophy. J
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2. Nothnagle M, Taylor JS. Vaginal estrogen preparations for relief of atrophic vaginitis. Am Fam
Physician. 2004;69:2111-2.
3. Willhite LA, O'Connell MB. Urogenital atrophy:
Prevention and treatment. Pharmacotherapy. 2001;
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4. Kalogeraki A, Tamiolakis D, Relakis K et al.
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5. Pandit L, Ouslander JG. Postmenopausal vaginal atrophy and atrophic vaginitis. Am J Med Sci.
1997;314:228-31.
6. Bachmann GA. Influence of menopause on
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1:16-22.
7. Stenberg A, Heimer G, Ulmsten U, Cnattingius
S. Prevalence of genitourinary and other climacteric
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8. Hendrix SL. Long-term use of hormone therapy
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North Am. 2003;87:1029-37.
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Menopause. 1, 39-48. 1994. Ref Type: Journal (Full)
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11. Bachmann GA, Leiblum SR. The impact of
hormones on menopausal sexuality: A literature
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12. Johnston SL. Urogenital health. Canadian
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126-33.
14. Jepson RG, Mihaljevic L, Craig J. Cranberries
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1. Physiologic changes that occur with
vaginal atrophy include
a) increase in blood flow to the vagina.
b) enhancement of the vaginal epithelium
and lining.
c) loss of vaginal elasticity.
d) none of the above.
4. Some lifestyle recommendations that
could be recommended for Joan to help
with her symptoms include
a) quit smoking.
b) masturbation.
c) avoid douches or perfumed products.
d) all of the above.
d) None of the above
2. The following are all symptoms of
vaginal atrophy EXCEPT
a) decreased vaginal lubrication.
b) dyspareunia.
c) vaginal pruritis.
d) decreased urinary tract infections.
5. Which would be the most appropriate
hormonal option for Joan in relieving
her symptoms of vaginal atrophy?
a) Transdermal estrogen such a patch,
50 µg applied twice weekly.
b) Vaginal conjugated estrogen (CE) cream
administered 0.3 mg daily for the first two
weeks, and then twice weekly.
c) Vaginal estradiol table (25 µg) once
weekly.
d) None of the above.
QUESTIONS
Case #1
Joan is a 54-year-old post-menopausal
woman who has symptoms of vaginal
atrophy, with her biggest complaint being
vaginal dryness and pain with intercourse. She has not tried anything for
vaginal dryness but would like some help
in relieving the symptoms. She feels her
sex life has suffered because of the pain
on intercourse. She feels she is smoking
more because of the increased stress in
her personal life.
(Questions 3 to 7 pertain to Case #1)
3. Which of the following are potential
risks or concerns if Joan is not treated
for her vaginal atrophy?
a) Vaginal ulceration
b) Vaginal cancer
c) Decreased quality of life
d) Endometrial hyperplasia
February 2005
6. The most common side effects associated with vaginal estrogen products
include all of the following EXCEPT
a) vaginal discharge.
b) vaginal irritation.
c) decreased urinary tract infections.
d) vaginal spotting.
7. If Joan had contraindications to estrogens, which would be appropriate nonhormonal options for Joan in helping
relieve her symptoms of vaginal atrophy?
a) A moisturizer such as Replens™ prior
to sexual intercourse
b) A lubricant prior to sexual intercourse
c) Wild yam cream
8. Which product would NOT be an option
for a post-menopausal woman with menopausal symptoms such as hot flushes,
night sweats and vaginal dryness?
a) Vaginal estradiol ring every 3 months
b) Estrogen gel every day
c) conjugated estrogen oral tablets
d) Estrogen patch twice weekly
9. Which statement is TRUE from the
SOGC consensus guidelines for the
management of vaginal atrophy?
a) Women experiencing recurrent urinary
tract infections should be instructed to
consume pure cranberry juice to decrease
their risk of urinary tract infections.
b) For menopausal women experiencing
recurrent urinary tract infections and
who have no contraindications to local
hormone replacement, vaginal estrogen
therapy can be recommended.
c) Systemic absorption of estrogen can
occur with vaginal estrogen preparations,
progestin should be recommended in all
women on vaginal estrogen.
d) None of the above.
10. Which factor is NOT an absolute
contraindication to the use of systemic
hormone replacement therapy?
a) Strong family history of heart disease
b) History of breast cancer
c) Unexplained vaginal bleeding
d) Acute liver disease
CE 7
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Page CE 8
QUESTIONS continued
Case #2
Ellen is a 56-year-old post-menopausal
woman with vaginal dryness, recurrent
urinary tract infections and stress incontinence. She has tried using cranberry
juice to help with the urinary tract infections but it has not helped and she has
been on numerous courses of antibiotics.
She has also used Replens™ for the last
year to help with the vaginal dryness but
with no relief. She is not complaining of
any menopausal symptoms.
(Questions 11 to 13 pertain to Case #2)
11. What would be the next appropriate
option to help with Ellen’s symptoms of
vaginal atrophy?
a) Estrogen gel twice weekly
b) Vaginal estrogen ring (new ring every
90 days)
c) Vaginal CE cream 1.25 mg every day
d) Vaginal estrogen tablet (25 µg) every
day
12. What would you tell Ellen about the
potential benefits that she may see with
vaginal estrogens in reducing her risk of
urinary tract infections?
a) Vaginal estrogens will have no effect on
the risk of recurrent urinary tract infections.
b) Vaginal estrogens will increase her risk
of urinary tract infections.
c) Vaginal estrogens may decrease her
risk of recurrent urinary tract infections.
d) Progestins should be used in combination with vaginal estrogens to see the full
benefit in reducing the risk of recurrent
urinary tract infections.
13. What would you tell Ellen about
the potential benefits that she may see
CE 8
with hormone replacement therapy in
helping with her symptoms of stress
incontinence?
a) The role of HT in stress incontinence is
unclear.
b) Only the combination of estrogen and
progestin has shown a benefit in urge
incontinence.
c) There may be a benefit for stress incontinence, however both estrogen and progestin have to be used together.
d) None of the above.
14. Which of the following would be
considered advantages of the vaginal
estradiol ring?
a) Uniform and sustained release of
estradiol directly to vaginal tissue
b) Very low systemic estrogen levels
c) Does not need to be replaced for
3 months
d) All of the above
15. Which of the following are advantages of conjugated estrogen vaginal
cream?
a) Very low systemic estrogen levels at
doses of 0.3 mg three times weekly.
b) A small amount can be applied to the
outer skin folds of the vagina to relieve
external irritation and dryness.
c) All of the above.
d) None of the above.
16. Why was the estrogen-alone arm of
the Women’s Health Initiative stopped
early?
a) Increased risk of breast cancer
b) Increased risk of coronary heart
disease
c) Increased risk of fractures
d) None of the above
17. The estrogen and progestin arm of
the Women’s Health Initiative was
stopped early because the increased
risk outweighed the potential benefits.
What were the risks associated with
estrogen and progestin?
a) Increased risk of breast cancer
b) Increased risk of fractures
c) Increased risk of colorectal cancer
d) All of the above
18. The current role of systemic HT, as
recommended by SOGC and NAMS,
include all of the following EXCEPT
a) relief of hot flushes.
b) relief of vaginal dryness.
c) relief of insomnia.
d) prevention of colorectal cancer.
19. Common side effect(s) of oral estrogens include
a) breast tenderness.
b) acne.
c) hirsutism.
d) all of the above.
20. Which statement(s) is/are TRUE?
a) All vaginal estrogen products (ie CE
cream, vaginal tablets and vaginal ring)
have been found to be effective for the
treatment of vaginal dryness.
b) Oral estrogens have been found to be
more effective for vaginal dryness than
vaginal estrogen products.
c) The vaginal ring has been found to
have fewer side effects compared to other
vaginal estrogen products.
d) All of the above.
February 2005
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