Topical sildenafil cream improved outcomes for some women with sexual arousal disorder

Key takeaways:

• Select women with sexual arousal disorder saw improved sexual function with topical sildenafil cream compared with placebo.
• Women with concomitant sexual dysfunction diagnoses saw no significant improvements.

In a phase 2b study, select healthy premenopausal women with sexual arousal disorder who received topical sildenafil cream reported improvements across multiple aspects of sexual function compared with those who received placebo cream.

Overall, topical sildenafil cream 3.6% (Daré Biosciences), developed for the treatment of female sexual arousal disorder and similar to oral sildenafil citrate, did not show statistically significant improvement over placebo in the coprimary or secondary endpoints among the intention to treat population, all of whom had female sexual arousal disorder but had a wide variety of concomitant sexual dysfunction diagnoses or symptoms. However, when the efficacy endpoints were compared in an exploratory post hoc analysis among a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, researchers observed trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream.

“We also found significant reductions in several measures of sexual distress and interpersonal difficulties among this subset population,” Andrea Ries Thurman, MD, FACOG, an obstetrician gynecologist and medical director of Daré Bioscience, and colleagues wrote in Obstetrics & Gynecology. “Although we recognize that exploratory post hoc subset analyses must be interpreted with caution and can introduce type I errors, we believe that the trends observed in this subset population are promising, are clinically meaningful, and warrant further study because an important objective of this exploratory phase 2 study was to identify which women with female sexual arousal disorder are most likely to benefit from the mechanism of action of sildenafil citrate to increase genital blood flow.”

Targeting vascular arousal response

For the exploratory study, researchers analyzed data from 200 premenopausal women with female sexual arousal disorder randomly assigned sildenafil cream (n = 101) or placebo (n = 99), with 174 women completing the study (sildenafil, 90; placebo, 84).

“We hypothesized that by delivering sildenafil citrate topically with a fast-absorbing delivery technology specifically targeting genital anatomy central to the vascular arousal response, there would be less systemic exposure, fewer systemic side effects, and a more immediate biological efficacy response,” the researchers wrote.

The coprimary efficacy endpoints were change from baseline to 12 weeks in the arousal sensation domain of the 28-item Sexual Function Questionnaire (SFQ28) and question 14 of the Female Sexual Distress Scale – Desire/Arousal/Orgasm (FSDS-DAO).

Among the intention-to-treat population, which included women with only female sexual arousal disorder and those with female sexual arousal disorder with concomitant sexual dysfunction diagnoses or genital pain, there were no statistically significant differences between sildenafil and placebo cream users in the coprimary and secondary efficacy endpoints. Women in the sildenafil cream group demonstrated greater improvement in the SFQ28 arousal sensation domain scores compared with placebo.

Improvements in sexual desire, sexual distress domains

In an exploratory post hoc analysis restricted to women with a diagnosis of female sexual arousal disorder with or without concomitant decreased desire, those who received sildenafil cream reported increases in their SFQ28 arousal sensation domain score compared with those who received placebo (least squares mean, 2.03 vs. 0.08; P = .04). In the same analysis, these women also saw a greater mean improvement in the SFQ28 desire and orgasm domain scores and reported reduced sexual distress and interpersonal difficulties with sildenafil cream use as measured by the FSDS-DAO scale (P for all < .04).

In a press release from Daré Bioscience, Thurman said arousal disorder represents a “significant unmet need,” affecting approximately 20% of women in the U.S.

“Publication of this efficacy manuscript in an important peer-reviewed medical journal validates the importance of these findings for the field, shedding light for the first time on which women with [female sexual arousal disorder] and symptoms can be expected to benefit most from the increased genital blood flow that sildenafil cream mechanistically provides, and further underscores the potential of sildenafil cream to address the unmet need and improve outcomes for women with [female sexual arousal disorder],” Thurman said in the release.

Reference:

• Daré Bioscience announces publication in Obstetrics & Gynecology of phase 2b study efficacy results of topical sildenafil cream 3.6% for the treatment of female sexual arousal disorder. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-announces-publication-obstetrics-gynecology. Published June 24, 2024. Accessed June 24, 2024.