Female sexual arousal disorder treatment study shows positive findings

Women’s health company Daré Bioscience has announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder (FSAD), has shown positive results.

The exploratory Phase 2b RESPOND study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and the questions to ask them, or the patient-reported outcome (PRO) measures, that best reflect that improvement.

The subset analyses compared efficacy endpoints based on study product use in pre-planned and post-hoc subsets of age, race, and medication use to help refine target populations in future studies of Sildenafil Cream, 3.6% for the treatment of FSAD.

“We believe that these data are an indication of the broad population of premenopausal women with FSAD who could potentially benefit from treatment with Sildenafil Cream,” said Sabrina Martucci Johnson, president and CEO of Daré Bioscience.

“We were pleased to see that age and race did not significantly impact response to Sildenafil Cream.”

“This analysis also explored other subgroups such as hormonal contraceptive users versus non-users,” said Dr. Annie Thurman, medical director at Daré Bioscience.

“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.”

As previously announced, safety and efficacy data from the Phase 2b RESPOND study have been published in The Journal of Sexual Medicine and Obstetrics & Gynecology, respectively:

Thurman, et al. “Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder.” The Journal of Sexual Medicine, 2024, 1-7. https://doi.org/10.1093/jsxmed/qdae089
Johnson, et al. “Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial.” Obstetrics & Gynecology, 144(2):p 144-152, August 2024. DOI: 10.1097/AOG.0000000000005648