(092) SEXUAL EXPERIENCES IN AN EXPLORATORY, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL OF SILDENAFIL, 3.6% CREAM FOR THE TREATMENT OF FEMALE SEXUAL AROUSAL DISORDER

Abstract

Abstract Introduction Quantifying the change in the mean number of satisfactory sexual experiences (SSEs) is an efficacy endpoint recommended by the US Food and Drug Administration in studies of treatments for female sexual dysfunctions (FSD), including female sexual arousal disorder (FSAD). Objective Post-hoc analysis of sexual experiences in a study of Sildenafil Cream, 3.6% for treatment of FSAD Methods Phase 2b, exploratory, randomized, placebo-controlled, double-blind study of Sildenafil Cream, 3.6% among premenopausal women with FSAD (NCT04948151). Following a baseline, single-blind, placebo, run-in period, participants were randomized and used investigational product (IP) at home for 12 weeks. Between monthly, in-clinic assessments, participants answered questions in an electronic diary (eDiary), within 24-hours of each sexual experience. Sexual experiences were categorized as “Partnered” versus “By Myself” and “Satisfactory” versus “Not Satisfactory”. eDiary question 11 (Q11) asked “Were conditions appropriate for satisfactory sexual activity (enough time, no distractions, etc.)?”. Changes from baseline in the mean number of SSEs was a secondary efficacy endpoint. The Orgasm domain (questions 22-24) of the Sexual Function Questionnaire (SFQ28) was an exploratory efficacy endpoint. Un-partnered women and women with sexual partners who did not sign informed consent were enrolled in the study, but in these cases (n=15), IP was only used in solo sexual experiences. Results Sildenafil Cream users had more sexual experiences and more un-partnered sexual experiences during the double-blind treatment period compared to Placebo Cream users. Sildenafil Cream users were significantly more likely to engage in sexual experiences even when conditions were not appropriate for a satisfactory experience. Although, the change from baseline in the mean number of SSEs at week 12 decreased during solo, un-partnered sexual experiences for both product groups (-0.12±0.27 for Sildenafil versus -0.04±0.32 for Placebo, p=0.85), during the double-blind treatment period, Sildenafil Cream users reported significantly higher proportions of SSEs during un-partnered sexual experiences (197/261, 75.5%) compared to Placebo users (116/187, 62.0%) (p=0.002). Despite Sildenafil Cream users engaging in a sexual experience more frequently when conditions were not appropriate, the proportion of SSEs during these events when Q11=“No” were not different between active (17/59, 28.8%) versus placebo (8/25, 32.0%) users (p=0.77). Finally, un-partnered women and women with un-enrolled sexual partners, who by definition had only solo sexual experiences, had an increase from baseline in their SFQ Orgasm at week 12 with Sildenafil use (2.58±1.13) versus Placebo users in this subset, who had decreases in this score (-0.34±1.13) (p=0.13). Conclusions These data support that Sildenafil Cream 3.6% enhanced solo, un-partnered sexual experiences, which represented approximately 1 in 5 events in this FSAD treatment study. Disclosure Yes, this is sponsored by industry/sponsor: Dare Bioscience and Strategic Science and Technologies LLC Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Dare Bioscience and Strategic Science and Technologies LLC.