(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
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).
Post-hoc analysis of sexual experiences in a study of Sildenafil Cream, 3.6% for treatment of FSAD
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.
Sildenafil Cream users had more sexual…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
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