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10/12/2015 Making Midlife Sex Fun Again: strategies and solutions Karen E. Adams MD, FACOG Professor, Obstetrics and Gynecology Director, Over 40 Clinic, Center for Women’s Health Oregon Health and Sciences University Disclosures • I have no commercial interest in any products discussed • I have no commercial interest in sex OHSU Center for Women’s Health Over 40 Clinic 1 10/12/2015 Percentage of Men and Women with Sexual Complaints National Social Life, Health & Aging: Sexual Dysfunction in the US Laumann EO, et al. JAMA 1999-281(6):537-544 How Are We Doing? • REVIVE (REal Women’s Views of Treatment Options for Menopausal ChangEs) survey of postmenopausal women • Only 19% of health professionals addressed their sexual lives • Only 13% specifically asked about genitourinary symptoms • 40% expected their provider to initiate the discussion J Sex Med 2013; 10:1790-1799 2 10/12/2015 Approach to the Patient • TREAT PAIN • EXPLAIN WHAT’S NORMAL FOR WOMEN • ADDRESS LACK OF LIBIDO 3 10/12/2015 Cycle of dyspareunia Inhibited desire / sexual aversion Pain with intercourse Lack of lubrication and expansion Failure of excitement Genitourinary Syndrome of Menopause (GSM) • New term that replaced “vulvovaginal atrophy” in 2014 • A collection of symptoms and signs associated with a decrease in estrogen and other sex steroids • Involve changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder Genitourinary Syndrome of Menopause • SYMPTOMS • Genital dryness • Decreased lubrication with sexual activity • Discomfort or pain with sexual activity • Post-coital bleeding • Decreased arousal, orgasm, desire • Irritation, burning, or itching of vulva or vagina • Dysuria • Urinary frequency/urgency • SIGNS • • • • • • • • • • • Decreased moisture Decreased elasticity Labia minora resorption Pallor/erythema Loss of vaginal rugae Tissue fragility/fissures Urethral eversion or prolapse Loss of hymenal remnants Prominent urethral meatus Introital retraction Recurrent UTIs 4 10/12/2015 Treatment of GSM • Nonprescription therapies • Vaginal moisturizers (Replens, Vagisil, Vit E oil) • Herbal products (black cohosh, soy) not beneficial • Prescription therapies • Systemic ET used for other menopausal symptoms will often provide relief for GSM as well (75%) • Local ET more effective (80-90%) • Systemic ET associated with an increase in stress incontinence Local Estrogen • Cochrane Review of 19 studies including 4000 PMP women using local estrogen All delivery methods essentially equal in relieving effects of GSM whether ring, tablet or cream Some safety concerns with cream Suckling, Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001500 Local Estrogen Preparation Dosing Regimen (by manufacturer) Estring® 7.5mcg E2/day 90d ring Ring inserted vaginally and replaced/removed in 90d Vagifem® 10mcg E2/tablet QHS x 14d then 2x/week Premarin® cream 0.625mg CEE/g 0.5g cream 2x/week Estrace® cream 100mcg E2/g 2-4g QHS x 7-14d then 1g 1-3x/week 5 10/12/2015 Other Local Therapies Ospemifene • Only SERM approved in US for treatment of moderate to severe dyspareunia • • • • Improved VMI, vaginal pH, dryness in 52-week study 60 mg per day orally No VTEs or hyperplasia but small n = 180 Vasomotor sxs 2% placebo/7% ospemifene • INVESTIGATIONAL • Bazedoxifene 20 mg/Conjugated Estrogen 0.45 or 0.625 mg • Intravaginal DHEA (“dietary supplement”) • Both in phase 3 trials Diff Dx of GSM: other sources of pain • • • • • • • Infectious diseases (candida, BV, trich, GC/CT) Irritant or allergic vulvitis (soaps, perfumes, panty liners) Vestibulodynia Levator myalgia Vulvar dermatoses Desquamative inflammatory vaginitis Painful bladder syndrome/interstitial cystitis Sexual counseling • Several studies show profound psychological, physical, and emotional impact of vulvar pain • Unique impact on intimacy • CBT counseling alone improves pain • 76 women x 12 sessions of group CBT • Reported less coital pain, increased satisfaction, reduced overall pain Bergeron, Pain 2001, 91(3):297 Ter Kuile, J Sex Marital Ther 2006;32:199 6 10/12/2015 What’s Normal for Women? Traditional Model of Sexual Response Masters & Johnson/Singer Kaplan Orgasm Plateau Sexual Excitement/ Tension Arousal Reduction Desire Time Basson 2001 “Basson Model” Female Sexuality Orgasm Emotional Intimacy + + Motivates the sexually neutral woman Emotional and Physical Satisfaction To find/ be responsive to Sexual Stimuli Psychological and biological factors govern “arousability” Arousal & Sexual Desire Sexual Arousal Basson 2001 7 10/12/2015 New Sexual Response • Enhanced intimacy is a strong stimulus for women to seek partnered sexual activity • Positive sexual experiences motivate women to be sexual again-therefore allowing sexual stimuli to move her from neutral to an aroused sexual state • Spontaneous desire is not a measure of sexual satisfaction Basson. J Psychosom Obstet Gynecol 2003;24:221-29 Bancroft J. Clinics in Obstet Gynecol 1980;7:253-278 Seagraves. J Sex Med 2007;4:567-80. How to Approach Lack of Libido Factors that Predict an Active Sex Life for Women • Overall psychological health • Overall physical health/exercise • A new relationship! 8 10/12/2015 Overall Psychological Health • High correlation of desire complaints with: • Low self image • Weak or fragile selfesteem • Mood instability • Tendency toward worry and anxiety Overall Physical Health • Having sex can feel like working out to someone who is not connected to her body • Routine exercise is helpful • Start slowly! Just walking can be beneficial A New Relationship • “Hormone cocktail of romance” • Dopamine • Norepinephrine • Phenethylamine • Evolutionary anthropologists tell us this lasts only a few years at best • This is the psychologically healthy, reasonably fit patient who says, “We love each other. Our relationship is great, but we hardly ever have sex.” 9 10/12/2015 The Effect of Longevity • University of Hamburg surveyed 2500 men and women • In new relationships, women’s lust = men’s lust • After 1-4 years in a relationship, women’s lust dives • This drop continues over time, leaving male desire far higher • Women who don’t live with their partners retain desire much more than women who do • Lesbian women fare no better, and are perhaps worse The Effect of Novelty • Queen’s University, Ontario measured vaginal and penile blood flow of heterosexuals while they watched one-minute pornographic sex scenes repeatedly • Breaks in between to allow return to baseline • Both women and men’s responses leaped at first • Men’s responses typically stayed more constant while women’s plummeted with repetition • Both spiked again when researchers introduced new clips 10 10/12/2015 “Doctor, is there a pill I can take?” Testosterone • 300 mcg transdermal patch • Several studies showed a small increase in “sexually satisfying events” over baseline in PMP women • FDA rejected in 2004 citing concerns re: off-label use and safety • At least one study showed increased breast cancer rates with patch, also CV concerns Testosterone • NAMS 2005 position statement on T therapy has been retired, currently no official statement • US Endocrine Society recommended against T therapy in 2006 due to lack of a well defined clinical syndrome and normative data on free and total T levels in women across their lifespan • LibiGel transdermal T gel was rejected by the FDA in 2011 when results were no better than placebo, Phase 3 trials continuing • T dosing remains off-label in the form of cream or gel 11 10/12/2015 Testosterone is not the magic bullet What to tell your patient 1. Testosterone is considered experimental & is not commercially available for women in the dose associated with improved sexual outcomes 2. Long-term safety not established 3. Strong placebo effect repeatedly seen 4. Sexual outcomes not correlated with serum androgen levels 5. May be some risk for breast cancer & CVD 6. Trials are ongoing Flibanserin: Politics and Science 12 10/12/2015 Flibanserin: Science • 5-HT mixed receptor agonist and antagonist • Increases downstream release of dopamine and norepinephrine • Reduces serotonin • mediates symptoms of reduced sexual interest and desire • FDA unanimously rejected the new drug application in 2009 • Drug increased satisfying sexual episodes by an average of 1.7 per month compared to 1.0 per month by placebo • BASELINE 2.7 • PLACEBO 3.7 • FLIBANSERIN 4.5 Flibanserin is NOT “The Female Viagra” Flibanserin: Science • Viagra increases blood flow to the penis, Flibanserin works on the brain • Viagra works almost instantly, Flibanserin takes four weeks to be effective and peak results seen at eight weeks • Flibanserin estimated to be effective in 1 in 10 women vs. 1 in 3 that have arousal/desire disorders • Viagra has a very robust response in men, Flibanserin’s effect is modest at best in women • SIDE EFFECTS/RISKS: nausea, dizziness, syncopal episodes 13 10/12/2015 Flibanserin: Science • The drug manufacturer dealt with dizziness by designing studies with a single nighttime dose • Demonstrated that next-day driving skills were not affected • Most worrisome side effect is syncope (loss of consciousness due to sudden or substantial drop in blood pressure) • Enhanced when drug combined with alcohol, esp in people who do not normally drink, or when patient takes other drugs that utilize the CP450 pathway Flibanserin: Public Relations • Sprout Pharmaceuticals acquired the rights to Flibanserin in 2010 • At that point had two unsuccessful FDA hearings • Partnered with Even the Score, a campaign by 24 women’s groups that list 26 drugs for men’s sexuality, 0 for women Even the Score • 30 patients brought in by Sprout to testify at a 2-day FDA workshop on patient-focused drug development in female sexual dysfunction • Advocates say that critics minimize the suffering of women • FDA advisory committee members voted 18-to-6 to approve with a risk management plan for patients • Many said it was a difficult choice between that vote and a straight “no” vote but many voices are charging the FDA with gender discrimination 14 10/12/2015 Controversy • Dr. Adrien Fugh-Berman: “What we have here is a mild aphrodisiac with scary side effects.” • Dr. Susan Wood: “I find the gender bias charges not only not persuasive but offensive…We have a product without particularly high efficacy, [that] comes with risks, has to be taken on a daily basis for weeks or months or years, and in my view would be widely marketed off-label, putting women at risk who would see no benefit at all.” • Sprout said it would refrain from direct-to-consumer advertising in the first 18 months after approval • Approved Sept 2015 for premenopausal women • Sprout was sold the next day! • No current “to market” date • Provider certification will be required to prescribe 45 15 10/12/2015 “No pill?! Then what?” Monogamy = death of desire? • When you love someone, how does it feel? • When you desire someone, how is that different? • Does good intimacy = good sex? • Can you desire something you already have? • Esther Perel Mating in Captivity, 2006 Love and desire • Love wants to know all about you • Desire needs mystery • Love wants to shrink the distance between us • Desire is energized by it • Intimacy grows through repetition and familiarity • Eroticism is numbed by repetition and thrives on the mysterious, the novel, the unexpected • Love is about having • Desire is about wanting 16 10/12/2015 “In this world there are only two tragedies. One is getting what one wants, the other is not getting it.”—Oscar Wilde The key to making midlife sex fun again is wanting what you have, recognizing the separateness of the other Moving to a drug without psychotherapy and behavioral intervention is inappropriate Summar Midlife Sex: Summary • • • • • Start by treating sources of pain Help women understand what is normal for them There is no pharmacologic panacea for low libido Mental and physical health contribute to a healthy sex life The intimacy, companionship, and familiarity of a long term relationship can stifle desire • Desire thrives on mini-separateness and novelty • Long term couples can bring the erotic home through active engagement and intention “Passion is for teenagers and foreigners” --Marge Simpson 17