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Evaluating Medications for Women with Female Sexual Dysfunction

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Evaluating Medications for Women with Female Sexual Dysfunction Evaluating medications for women with female sexual dysfunction Laura S. Dalton, DO The only medications currently approved for a specific sexual dysfunction are phos - phodiesterase type-5 inhibitors, which are used to treat men with erectile dysfunction. Any medications used for female sexual dys - function (FSD) are used off-label. In the past few years, pharmaceutical companies have presented applications for several FSD medications to the U.S. Food and Drug Administration (FDA). However, the FDA has denied approval for these medications, either because of a paucity of long-term safe - ty data or because of a failure to demonstrate statistically significant improvement in symptoms (ie, “satisfying sexual events”) compared with placebo. Sexual dysfunction is not life-threaten - ing and does not produce a serious impact on patients’ physical health. Thus, to re - ceive FDA approval for sexual dysfunction, medications must meet the highest levels of quality of evidence in efficacy and safe - ty. 1,2 My purpose in this article is for it to serve as a review of medications that are ei - ther already available for FSD or under terone in women and increased risk of an - Health Initiative (WHI) study. 10 In that ran - investigation for FSD. drogenic adverse effects, such as hirsutism, domized controlled trial, women were asked voice changes, acne, and clitoromegaly. They about their overall sexual function—but not Testosterone also have an adverse impact on lipid levels desire—and results were tabulated using a Testosterone supplementation has been ex - in women. Compounded 1% testosterone Likert scale. The WHI investigators found tensively studied in postmenopausal women, cream in petrolatum has been used histori - no differences in sexual function between though it remains unapproved by the FDA cally as a treatment for lichen sclerosis et women taking conjugated equine estrogen/ for use in women with FSD. 1,3 A twice- atrophicus, and it may be appropriate for medroxyprogesterone acetate and women weekly testosterone patch designed for use some women if applied nightly at a dose of taking placebo. 10 in women has shown efficacy in women with 0.5 g. However, although gynecologists may It’s important to note that the WHI did hypoactive sexual desire disorder (HSDD), feel comfortable prescribing this cream, it not measure satisfying sexual events, 10 but availability is pending and dependent should be kept in mind that no safety or which are now considered the primary end - on long-term safety data. 4-8 Interestingly, efficacy data exist for this compound’s use point for treatment of patients with FSD. studies on use of the testosterone patch for in managing FSD. Furthermore, the WHI did not screen FSD have suggested efficacy at moderate study participants for FSD, and many of doses but little improvement at higher doses. 9 Hormone therapy the participants were older than the typi - Testosterone products formulated for Although anecdotal evidence and some study cal woman with FSD. 10 men should not be used to treat women data suggest that hormone therapy may For patients requiring postmenopausal with FSD, because such products result in improve sexual desire in women, such re - hormone therapy, formulations of esterified extremely high physiologic levels of testos - sults were not observed in the Women’s estrogens and methyltestosterone may be used 16 to increase testosterone levels. 11,12 These approach is anecdotally effective. products are not FDA-approved for FSD, Bupropion hydrochloride has norepi - though several studies have shown that they nephrine and dopamine reuptake inhibition can improve sexual functioning in women. 13 , 14 effects and has been shown to improve sex - Vaginal estrogen therapy—including ual satisfaction, arousal, and orgasm. 23,24 creams, tablets, and rings—can be used This drug may be considered as an alterna - successfully to improve atrophic changes tive medication for women in whom FSD in postmenopausal women. Correcting develops with use of SSRIs for depression. these changes can reduce vaginal discom - Sildenafil citrate, approved for male fort and improve sensation. Local estrogen erectile dysfunction, has been studied ex - therapy does not produce the potentially tensively in women. Results are inconclusive. harmful blood levels of estrogen that can Although an off-label use, antidepressant-in - occur with systemic therapy, and, thus, it duced sexual desire problems in women have is viewed as less risky. 15 improved with episodic use of sildenafil (50 mg) taken one hour before sexual act ivity. 25 Other pharmacologic agents Other studies have shown some success in Final notes Laboratory studies and clinical observations using sildenafil for women with sexual arousal There are no FDA-approved pharmacologic have shown that changes in neuro - disorder, including postmenopausal women treatments for FSD—including HSDD, or - transmitter activity can cause changes in and even asymptomatic women. 25-28 gasmic dysfunction, or arousal disorder. sexual desire. In general, serotonergic activ - Local creams and gels are available to Many medications, especially neurotropic ity is inhibitory and dopaminergic activity improve sensation of the external genitalia. drugs, migraine preventatives, and antide - is facilitatory to sexual desire. 16 An applica - For example, a blend of over-the-counter pressants can induce sexual dysfunction, tion to use flibanserin (a 5-HT2 receptor herbs and vitamins marketed as “feminine especially HSDD and orgasmic dysfunction. antagonist and 5-HT1 receptor agonist) to massage oil” has been demonstrated to re - Several medications have been studied modulate neurotransmitter levels in pre - sult in improvement in satisfaction and level for use in women with FSD, with varying menopausal women with low sexual desire of interest in women with disorders of sex - results. Most of these studies have had small was recently presented to the FDA. The reg - ual desire and arousal. 29,30 Other kinds of sample sizes and varying endpoints. None ulatory agency determined, however, that over-the-counter creams or gels lack clinical of the studies measured effects of the med - the drug did not meet criteria for efficacy. data establishing their efficacy over placebo. ications on sexual satisfaction. Testosterone The FDA also cited evidence of statistically is known to increase sexual desire in significant adverse events associated with Nonpharmacologic therapy women, though formulations designed for flibanserin, including depression, syncope, An FDA-approved clitoral suction device men should not be used for women. fainting, and accidental injury. 17-21 The can be used to cause clitoral vascular en - Knowledge about the role of estrogen ther - manufacturer has since withdrawn its appli - gorgement. Studies have shown that this apy in menopausal women remains limited. cation for FDA approval of flibanserin. 22 device can cause improvement in arousal, Hormone therapy is FDA-approved only Monoamine oxidase inhibitors, tricyclic genital swelling, vaginal lubrication, and for the treatment of women with meno - antidepressants, and selective serotonin re - enhancement of orgasm. 31-33 Originally pausal syndrome. uptake inhibitors (SSRIs) have all been recommended for use immediately prior Physicians should consider off-label shown to inhibit sexual activity in women. to sexual activity, the device is now recom - treatments only for well-selected patients Antidepressant-induced FSD may be im - mended for use three to four times per week and after thorough discussion of the risks proved by changing medications. To independent of sexual activity to improve and benefits with these patients. We can manage SSRI-related orgasmic dysfunction, genital blood flow and sensation. The look forward to continued research and de - some physicians use a short-acting SSRI device is a prescription item that is avail - velopment of medications to help women that a patient can skip for a weekend. This able via the Internet. with the distressing disorder of FSD. 17 References 14. Sarrel P, Dobay B, Wiita B. Estrogen and 24. Ashton AK, Rosen RC. Bupropion as 1. Fallon B. ‘Off-label’ drug use in sexual medicine estrogen-androgen replacement in postmenopausal an antidote for serotonin reuptake inhibitor-i treatment. Int J Impot Res. 2008;20(2):127-134. women dissatisfied with estrogen-only therapy: nduced sexual dysfunction. J Clin Psychiatry. sexual behavior and neuroendocrine responses. 1998;59(3):112-115. 2. Jayne C, Gago BA. Diagnosis and J Reprod Med. 1998;43(10):847-856. treatment of female sexual arousal disorder. 25. Wylie K, Malik F. Review of drug treatment Clin Obstet Gynecol. 2009;52(4):675-681. 15. North American Menopause Society. for female sexual dysfunction. Int J STD AIDS. The role of local vaginal estrogen for treatment 2009;20(10):671-674. 3. Panay N, Al-Azzawi F, Bouchard C, et al. of vaginal atrophy in postmenopausal women: Testosterone treatment of HSDD in naturally 2007 position statement of The North American 26. Schoen C, Bachmann G. Sildenafil citrate for menopausal women: the ADORE study. Menopause Society. Menopause. 2007; female sexual arousal disorder: a future possibility? Climactetric. 2010;13(2):121-131. 14(3 pt 1):355-369. Nat Rev Urol. 2009;6(4):216-222. 4. Krapf JM, Simon JA. The role of testosterone 16. Segraves R, Woodard T. Female hypoactive 27. Berman JR, Berman LA, Toler SM, Gill J, in the management of hypoactive sexual desire desire disorder: history and current status. Haughie S; Sildenafil Study Group. Safety and disorder in postmenopausal women. Maturitas. J Sex Med. 2006;3(3):408-418. efficacy of sildenafil citrate for the treatment 2009;63(3):213-219. of female sexual arousal disorder: a double-blind, 17. Moynihan R. Major changes are proposed placebo controlled study. J Urol. 2003;170(6 pt 5. Feldhaus-Dahir M. Testosterone for the for definitions of female sexual dysfunction. 1):2333-2338. treatment of hypoactive sexual desire disorder: BMJ. 2010;340: c830. part II. Urol Nurs. 2009;29(5):386-389,378. 28. Caruso S, Intelisano G, Lupo L, Agnello C. 18.
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