Sildenafil cream for female sexual arousal disorder available to prescribe in select states

Study participants used Sildenafil Cream and

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Traish AM, Kim NN, Munarriz R, Moreland R, Goldstein I. Biochemical and physiological mechanisms of female genital sexual arousal. Arch Sex Behav 2002;31:393–400. In vitro functional responses of isolated human vaginal tissue to selective phosphodiesterase inhibitors. J Sex Med 2007;4:1604–9.

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doi: 10.1111/j.1743-6109.2007.00595.x Uckert S, Oelke M, Albrecht K, Breitmeier D, Kuczyk MA, Hedlund P. Expression and distribution of key enzymes of the cyclic GMP signaling in the human clitoris: relation to phosphodiesterase type 5 (PDE5). J Sex Med 2007;4:602–8. doi: 10.1111/j.1743-6109.2007.00490.x Sexual motivation in couples coping with female sexual interest/arousal disorder: a comparison with control couples. A systematic literature review of health-related quality of life measures for women with hypoactive sexual desire disorder and female sexual interest/arousal disorder. placebo cream over 12 weeks in

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Frequently asked questions

A limitation of this exploratory study was that it was underpowered to demonstrate statistically significant changes in the primary and secondary efficacy endpoints among the ITT population, all of whom had female sexual arousal disorder but were heterogeneous in their concomitant sexual dysfunction diagnoses or symptoms. Because this study was the first efficacy study of topical sildenafil cream among healthy premenopausal women with a main complaint of female sexual arousal disorder and because there are no FDA-approved treatments for female sexual arousal disorder, the main benefits of this study were to characterize the sexual response affected by arousal dysfunction, to evaluate the patient population based on concomitant diagnoses and medications, to identify endpoints to take forward in clinical development, and to provide data for psychometric validation of the study endpoints, including identifying the magnitude of within-patient change corresponding to a meaningful within-patient improvement. We based our sample size calculations on previous studies of FDA-approved products for hypoactive sexual desire disorder with or without concomitant decreased sexual arousal16,17,31–34 because there are no approved products for female sexual arousal disorder. We reviewed the published data for female sexual dysfunction treatments and expected a two-point increase in the SFQ28 domains and a 0.5-point decrease in question 14 of the FSDS-DAO. Although we did not achieve these changes in the entire ITT population, we consistently achieved or exceeded these improvements among the subset population of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire.

Cite this article

As seen in registration trials for hypoactive sexual desire disorder treatments,16,17,31–34 another limitation of our study was the relatively homogeneous population of college-educated White women. We acknowledge that the requirement to enroll sexual partners likely limited enrollment of Hispanic and non-Hispanic Black women and hypothesize that removing this requirement from future studies will result in a more diverse patient population. In particular, in an exploratory analysis of a subset of women with female sexual arousal disorder with or without concomitant decreased desire, topical sildenafil increased sexual arousal sensation, desire, and orgasm and reduced sexual distress. Will individual participant data be available (including data dictionaries)? What data in particular will be shared? non-drug and placebo cream run-in period.

Risk	Details	Precaution
Cardiovascular complications	Increased blood pressure, arrhythmias	Screen for cardiovascular disease before use
Drug interactions	Severe hypotension, adverse effects from combinations	Complete medication history before prescribing
Allergic reactions	Rashes, swelling, difficulty breathing	Discontinue and seek medical attention if occurs
Psychological dependency	Over-reliance on medication for arousal	Counseling for emotional health
Misuse and overdose	Increased adverse effects	Strict adherence to prescribed dose

All participants had a main diagnosis

Efficacy of Sildenafil Citrate on Female Sexual Dysfunction in A Sample of Egyptian Females, A Prospective Placebo Controlled Study

Bremelanotide for female sexual sildenafil pink pill dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Womens Health (Lond) 2016;12:325–37. Effect of intravaginal dehydroepiandrosterone (Prasterone) on libido and sexual dysfunction in postmenopausal women. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study.

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doi: 10.1016/s0090-4295(02)01663-1 Mayer M, Stief CG, Truss MC, Uckert S. Phosphodiesterase inhibitors in female sexual dysfunction. Expression of cAMP and cGMP-phosphodiesterase isoenzymes 3, 4, and 5 in the human clitoris: immunohistochemical and molecular biology study. doi: 10.1016/j.urology.2005.11.055 Park K, Moreland RB, Goldstein I, Atala A, Traish A. Sildenafil inhibits phosphodiesterase type 5 in human clitoral corpus cavernosum smooth muscle. of FSAD and may have also had

• Clinical research into sildenafil for women includes various dosage trials.
• Women using sildenafil should monitor blood pressure to avoid adverse effects.
• The safety profile of sildenafil in women is less documented than in men.
• Sildenafil’s impact on female sexual desire is still under scientific investigation.
• Women should avoid sildenafil if pregnant or breastfeeding unless prescribed.
• Alternative therapies for female sexual dysfunction include counseling and hormone therapy.

concomitant sexual dysfunction diagnoses or symptoms including

• The legality of women using sildenafil varies by country and local regulations.
• Lifestyle modifications can complement medication for better sexual health outcomes.
• Women with diabetes may have different responses to sildenafil therapy.
• The stigma surrounding female sexual dysfunction can hinder treatment seeking.
• Advances in research are aimed at developing female-specific ED medications.
• Open discussions with physicians are essential for safe and effective treatments.

decreased desire, orgasmic dysfunction, and genital pain.

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Further, data from a thermography study in healthy women demonstrated significantly greater increases in genital temperature after administration of Sildenafil Cream compared to placebo cream, indicating a positive impact on genital blood flow during the 30-minute testing session, with statistical separation from placebo within the first 15 minutes after dosing. We also completed a content validity study designed to identify and document the genital arousal symptoms that are the most important and relevant to women with FSAD. The findings of this study helped facilitate alignment with the FDA on acceptable efficacy endpoints for the Phase 2b RESPOND study and a future Phase 3 program. The Phase 2b study was an exploratory study to evaluate a number of primary endpoints and secondary endpoints as well as to identify a target patient population for Sildenafil Cream, 3.6%. The Phase 2b clinical study was designed as a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).