Sildenafil cream demonstrates safety, efficacy in phase 2b study for female sexual arousal disorder

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Daré Bioscience has announced the publication of additional data from its exploratory phase 2b RESPOND clinical study of sildenafil cream 3.6%, an investigational topical treatment for female sexual arousal disorder (FSAD). The findings, published in Sexual Medicine, underscore the cream’s potential as an effective, on-demand treatment for FSAD, a condition that affects millions of women.¹

FSAD, clinically analogous to erectile dysfunction (ED) in men, is characterized by a persistent inability to achieve or maintain sufficient genital arousal, often resulting in distress or interpersonal difficulties. Unlike ED, there are currently no FDA-approved pharmacological treatments for FSAD. Sildenafil cream, designed for topical application, aims to increase genital blood flow and improve arousal responses while minimizing systemic side effects observed with oral sildenafil (marketed as Viagra).¹

The phase 2b trial enrolled 200 premenopausal women and investigated the effects of sildenafil cream compared to placebo over 12 weeks.

The primary endpoints included improvements in the Arousal Sensation (AS) domain of the Sexual Function Questionnaire (SFQ28) and reductions in sexual distress as measured by the Female Sexual Distress Scale (FSDS-DAO). Results showed significant improvements for users of sildenafil cream.²

Non-white participants using the cream experienced an increase in satisfactory sexual events (SSEs) by 0.7 events over the 12 weeks, while non-white participants in the placebo group reported a decrease of 1.5 events (P = .02).

Additionally, unpartnered women or those with unconsented partners using sildenafil cream demonstrated an improvement of 2.39 points in the Orgasm domain of the SFQ28, compared to a 0.19-point decrease in the placebo group (P = .06).²

Annie Thurman, MD, FACOG, medical director at Daré Bioscience, addressed the significance of findings related to hormonal contraceptive use. “Since hormonal contraceptive use has been associated with lower sexual desire as well as reduced sexual arousal in other studies, we wanted to understand how this medication use might impact the effect of sildenafil cream. Our data show, however, that there was no significant impact from hormonal contraceptive use on either the primary or secondary efficacy endpoints, so we were also pleased to see that hormonal contraceptive users could also potentially benefit from sildenafil cream,” she explained.¹

The study also revealed that daily psychiatric medication use was associated with lower scores in sexual desire, regardless of treatment group. However, participants not on daily psychiatric medications using sildenafil cream reported an increase of 1.85 points in the SFQ28 Desire domain, compared to a 0.52-point increase in the placebo group.²

Daré Bioscience designed the RESPOND study to refine the target population and patient-reported outcome measures that best reflect improvement with Sildenafil Cream.

According to Dare Bioscience, this research is critical to addressing the unmet needs of the approximately 10 million women in the United States, ages 21 to 60, who experience FSAD-related distress and are actively seeking solutions.¹

References:

1. Dare Bioscience. Subgroup Analyses in the Phase 2b RESPOND Clinical Study of Sildenafil Cream, 3.6%. Dare Bioscience. December 10, 2024. Accessed December 10, 2024. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-publication-sexual-medicine-positive

2. Johnson I, Thurman AR, Cornell KA, Dart C, Hatheway J, Friend DR, Goldstein A. Impact of age, race, and medication use on efficacy endpoints in a randomized controlled trial of topical sildenafil cream for the treatment of female sexual arousal disorder. Sex Med. 2024 Nov 19;12(5):qfae079. doi: 10.1093/sexmed/qfae079. PMID: 39564518; PMCID: PMC11576099.