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
Abstract
Abstract Background A study of topical Sildenafil Cream 3.6% was completed among healthy premenopausal women with female sexual arousal disorder. Aims To compare efficacy endpoints based on product use in pre-planned and post-hoc subsets of age, race, and medication use. Methods Phase 2b, exploratory, randomized, placebo-controlled, double-blind study of Sildenafil Cream, 3.6% among healthy premenopausal women with female sexual arousal disorder (FSAD). Eligible participants were randomized 1:1 to Sildenafil versus Placebo Cream and used investigational product for 12 weeks. Outcomes The co-primary efficacy endpoints were the change from baseline, at week 12, in the Arousal Sensation (AS) domain of the Sexual Function Questionnaire (SFQ28) and Question 14 (Q14) of the Female Sexual Distress Scale – Desire, Arousal, Orgasm (FSDS-DAO). The secondary efficacy endpoint was the change from baseline at week 12 in the mean number of satisfactory sexual events (SSEs) reported in a daily diary. Exploratory efficacy endpoints included the Desire and Orgasm domains of the SFQ28. Results Age group (≥18 years and ≤ 45 years versus >45 years), race group (White versus non-White), and baseline use/non-use of hormonal contraception did not significantly affect the co-primary endpoints of the SFQ28 AS domain and FSDS-DAO Q14 (P values >0.11). Non-White Sildenafil Cream users had an increase in SSEs at week 12 (0.7 ± 0.63) while non-white Placebo Cream users reported a decrease (−1.5 ± 0.58)…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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