10/24/2014. Definitions and Epidemiology Physiology of Female Sexual Response Female Sexual Dysfunction
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1 None to report Tami Serene Rowen, M.D. M.S. Department of Obstetrics, Gynecology and Reproductive Sciences University of California, San Francisco October 24, 2014 Definitions and Epidemiology Physiology of Female Sexual Response Female Sexual Dysfunction Classification Risk Factors Evaluation Treatment A state of physical, emotional, mental and social wellbeing in relation to sexuality Not merely the absence of disease, dysfunction or infirmity Requires the possibility of safe and pleasurable experiences An important and integral aspect of human development and maturation A human right -WHO Tech Consultation Sex Health
2 Largest study(13882 women, 29 countries) 65% women sexually active in last year 38% in last week(inverse age relationship) Agrees with US data 20-37% reported sex was very/extremely important to life 76% women felt satisfactory sex is essential to maintain a relationship Sexual well being significantly correlated to self perceived overall health Do patients want to discuss sex? While 85% of adults want to discuss sexual functioning with their physicians 71% believe their physicians doesn t have the time 68% don t want to embarrass their physician 76% thought no treatment was available for their problems 22% of women over 50 report discussing sex with a physician Laumann et al, 2006; Nicolosi et al, 2004; Lindau 2007 Marwick et al, 1993; Maurice et al 1999, Lindau et al 2007 Only 25% of primary care physicians take a sex history Jonassen et al 2002 How do gynecologists do stack up? Cross sectional study of 1,154 US Gynecologists 63% ask about sexual activity 40% ask about sexual function <30% ask about sexual orientation & satisfaction Sobeicki et al 2012 Laumann 1999: 1,749 US women age ~43% prevalence based on 7 single item dichotomous questions Bancroft 2003: Interview of 987 women % prevalence of self reported distress Shifren 2008: 31,581 US women >18 years 43% reported sexual problem 22% reported sexual distress 12% reported both sexual problem and distress 2
3 Our patients would like to discuss sex More than 10% likely have a distressing problem Many of us don t ask about it Unsure how to ask Uncertainty what to ask Unfamiliar with treatment options Masters & Johnson 1964 Male Female Rewards: Sexual and nonsexual Numerous Incentives for Sex Responsive Desire Innate Sexual Desire? Sexual Receptive -ness Masters & Johnson 1964 Basson et al 2004 Sexual Arousal Sexual Stimuli 3
4 Cross sectional study 404 women Linear model was good fit in mixed population of women Circular model fit better in women with dysfunction Giles & McCabe 2009 Cross sectional study 129 nurses 2/3 subjects endorsed linear model Sexual function scores significantly lower in women who endorsed Basson model Sand & Fisher 2007 Classification of Female Sexual Dysfunction DSM IV Persistent or recurrent, causing personal distress Desire Disorders Hypoactive Sexual Desire Disorder Sexual Aversion Disorder Sexual Arousal Disorder Genital Subjective Mixed Anorgasmia Sexual Pain Disorders Dyspareunia Vaginismus Non-coital sexual pain disorders DSM V Updates Must have 6 months of sx Medical conditions, medications and other psychological dx cannot account for sx HSDD, sex aversion and arousal disorders replaced by Sexual desire/arousal disorders Vaginismus and dyspareunia are combined into genito-pelvic pain/penetration disorder Still includes Orgasmic Disorder Lack of, or significantly reduced sexual interest, manifested by 3 of the following: Absent/reduced interest in activity Absent or reduced sexual thoughts/fantasies No/reduced initiation of sexual activity Absent/reduced excitement/pleasure Absent/reduced response to cues Absent/reduced genital sensations % prevalence Shifren et al, 2008; Seagraves and Woodard,
5 Genital pain associated with sexual stimulation 8-21% among 18-59, 14% among women Etiology Vulvar Vestibulitis Endometriosis Fibroids Surgery Psychosocial Vaginal Atrophy Inadequate lubrication Laumann et al, 1999; Laumann et al, 2005; Walton et al, 2003 Absence/Reduced orgasm after sufficient sexual stimulation and arousal Prevalence % Etiology Physical Medications Hormonal Psychological Shifren et al, 2008 Brief Index of Sexual Functioning for Women (BISF-W) 22 items, 7 domains, relationship focus Taylor et al, 1994 Female Sexual Function Index (FSFI) 19 questions, 6 domains Desire, arousal, lubrication, orgasm, satisfaction, pain Rosen et al, 2000 Female Sexual Distress Scale (FSDS, FSDS-R) 20(12) items, all focused on self reported distress Derogatis et al, 2002 Profile of Female Sexual Function (PFSF) 37 items, 7 domains, validated for women w/ BSO and HSDD McHorney et al 2004 Physical and Emotional Health status is #1 predictor! Laumann et al, 1999; Laumann et al, 2006; Nicolosi et al, 2004; Lindau et al, 2007 Role of age Filled circle =desire open triangle= arousal filled square= orgasm open diamond=any. Shifren et al, Obstet Gynecol 2008 Other factors: Relationship length (inverse correlation), education, mental health status, HRT and surgical menopause Hayes, et al 2008; Dennerstein
6 Pregnancy 90% still sexually active, drops dramatically third tri Von Sydow 2009 Post partum 50% rate dyspareunia Barret et al 2000 NO relationship between PP FSD and C/S vs SVD Higher rates of FSD with episiotomy and OVD Viswanthan et al 2006; Hannah et al 2004; Klein et al 1994 Breastfeeding associated with more dyspareunia but can stim arousal Signorello et al 2001; Avery 2000 Race and Ethnicity: conflicting data on sex activity among different groups Huang et al, 2009; Avis et al, 2005 Obesity: Higher BMI associated with more FSD Bariatric Surgery significantly improves sex QOL Kolotkin et al 2006; Sawer et al 2014 WSW: Distress associated with partner status, OAB Shindel, Rowen et al 2013 Women with Disabilities: no difference if rates of SA However less sex ed, higher risk of trauma Rowen et al, in press Focused history and physical May be useful to ask patient to describe most recent sexual experience Surveys may be of use-fsds, domains of FSFI Physical Exam: consider vulvoscopy screen for vag infxn PFMD Laboratory testing as indicated by H&P SSRIs Exception is buproprion Anti Psychotics Exception is mirtazepine CHC Anti-HTN Antihistamines Chemotherapy ACOG Practice Bulletin 2011, Parrish ISWWSH 2013 Goldstein,
7 Treat underlying disorders Address relationship Address psychosexual issues Sex Education Recalibrate expectations Sexual Enhancement treatments: gels and devices Pharmacotherapy? Caruso 2001: 53 women with FSD DB PC-crossover trial Improved arousal, orgasm, frequency of sexual intercourse No dose response Strong placebo effect Berman et al 2003: 202 menopausal women on HRT with FSD, RCT Improved FIEI for women with FSAD No effect on women with HSDD No increase in successful sexual activity % of participants sildenafil/ no HSDD sildenalfil/ HSDD placebo placebo sildenalfil/ HSDD sildenafil/ no HSDD Basson et al 2002: 781 women with FSD stratified by estrogen status No effects found in all categories Estrogenized women % improved sil 100 sil50 placebo Nurnberg et al, JAMA, women w/ depression on SSRI Sildenafil mg on demand vs. placebo 73% improved sex fnc on sildenafil, 28% on placebo Significant improvement in orgasmic score( above baseline on 6 point scale, CI ), p<0.01) placebo sil50 sil 100 7
8 Evidence equivocal for sildenafil use in women with arousal/hypoactive desire disorder Possible role of sildenafil for FSD associated with SSRI use Adverse Effects of sildenafil are: congestion, flushing, headache, dyspepsia, myalgias Can t take with nitrates(hypotension) No significant adverse events reported in studies on women Postsynaptic 5-HT1A agonist/5-ht2a antagonist (sim to buspirone) 3 Phase III RCTs done concurrently with 24 weeks tx (7 total RCTs) Thorp 2012 (DAISY): 1071 women with HSDD Placebo v Flibanserin 25, 50 BID, 100 q night Significant increase (~2/month) in SSE Subjective improvement of 44-47% (30% in placebo arm) 13.4 % discontinuation rate (vs10.1%) No major AE Derogatis 2012 (VIOLET): 663 women with HSDD Placebo v Flibanserin 50 & 100 mg Slight but significant increase in satisfying sexual events (SSE) from 0.8->1.4 and 1.6 (p<0.05) No major AE 2010:Female Viagra Hits Roadblock, FDA Denies Approval Benefits did not outweigh risks-including CNS effects Not enough sexual benefit based only on SSE not on other domains of sexual health Controversy re: how to measure improvement Kingberg and Althof, 2011 Taken up by new company. FDA again denied (2013) Estrogens Demonstrated effect on vaginal vascularity and baseline moisture Regular use associated with increased sex activity May improve other health measures Can use cream 3/week Estring q 3 months Vagifem 2-3/week SERMs Ospemafine: only FDA approved tx for FSF Tibolone: has P, E, & T activity Not approved in US Gass et al, 2011; Kovalevsky 2005, Lobo 2003, Basson 2004, Shifren 2000, Davis 2006, Nappi
9 Decreased starting age 30 Davis et al, 2005 No single androgen level predictive of sexual response Male levels of T associated with improved sex health Sig SE: hyperlipidemia, CVD,?carnogenic Sherwin&Gelfan 1987 Difference versus placebo in Study n= Treatment PFSF- PFSF- SSE Arousa Desire PDS AE Braunstein 447, surgically 2005 menopausal mcg/d NR 8* ~5* NS 6% Simon surgically menopausal 300mcg/d % Davis surgically menopausal 300 mcg/d % Shifren naturally menopausal 300 mcg/d % % Davis 2008b 814 menopausal, 150 or 300 mcg/d no E2 1.4* ~10 ~8 ~-11 0% 272 naturally Panay 2010 menopausal (26% on E2) 300 mcg/d 1.2 ~ % AE= Incidence of Adverse Events, FSFI=Female Sexual Function Index, FSDS=Female Sexual Distress Scale, NR= Not Reported, NS= Not significant, PFSF =Profile of Female Sexual Function, PDS= Personal Distress Scale, SSE=Satisfying = Sta s cally Significant (p<0.05) * = Significant differences only with 300 mcg/daily patch = women taking vaginal estrogens continued on stable dosing regimens Brand Name: Intrinsa No long term safety data More BTB, no increase hyperplasia Breast Ca: 4 vs 0 (2 in first year, 1 in 2 nd ) FDA agreed to efficacy but required more long term safety data: rejected in 2004 Note: only 3 months safety data required for men Approved in Europe but no market: no longer available Shifren ASRM 2013 Testosterone Cream (10mg) 1 RCT, 36 women with HSDD, surgically menopausal, on E2 sig increase in BISF-W(8.2 point, p<0.01) no mention of adverse events El-Hague et al, 2007 Transdermal Spray (2.8-9mg) 1 RCT, 261 pre-men women inc in SSE adverse events in 11-16%(acne, hirsutism) Davis et al, 2008 Can also use T pellets, topic gels ( Axiron ) 9
10 Libigel: daily 1% gel application Committed to long term safety trial 5 year f/u BLOOM phase III trials 1172 women no significance in ANY endpoint Company went bankrupt did not release safety data Shifren ASRM 2013,; Shafer 2011 Van Kesternen et al 1997: 297 F-M Transsexuals given T for 2 mo-41 years No difference in CAD rate compared to control Dutch women Braunstein 2007 : Review of TRT in women Major AE in women appear to be hirsutism, acne, and lowering of HDL with oral T over 1-2 year time frame Tamimi et al 2006: 70,444 post-menopausal women in Nurses Health Study taking E, E+P, E+T, or no hormones over 24 years Multivariate RR for breast CA was 1.77 (CI ) for E+T, 1.15 (CI ) for E, and 1.58 (CI ) for E+P Ness et al 2009: women in WHI, E+T vs no HRT Adjusted HR1.42; 95% confidence interval, p=.67) End of Libigel meant end of Testosterone solo therapy for FDA approval of FSD Data insufficient to demonstrate sig AE, incl breast ca Off-label use: what our societies say NAMS (2005): Postmenopausal women with decreased sexual desire associated with personal distress and with no other identifiable cause may be candidates for testosterone therapy. Testosterone treatment without concomitant estrogen therapy cannot be recommended because of a lack of evidence ACOG: Practice Bulletin (2012) : Transdermal Testosterone has been shown to be effective for the short term of hypoactive sexual desire disorder, with little evidence to support long term use (longer than 6 months) Level A Lybrido: SL Testosterone +sildenafil+ buspirone (Emotional Brain, NY) To be taken prior to sexual activity Currently just completed Phase II RCT 210 women, measuring dosage and SSE Comparison group: placebo, sildenafil testosterone 10
11 Bremalenotide DHEA Oxytocin Topical Prostaglandins Zestra All With Essentially Conflicting to Negative data for Effectiveness Female Sexual Health is complex but very important to women New research has opened door to physiologic factors Any treatment should be both medical and psychosocial Reliable and proven medical therapy for women with sexual problems is currently lacking Based on both outcomes and safety concerns Questions? 11
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