ArticleSexual medicine2024
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.
Article in Sexual medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
7 authors.
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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 ( Clinical Implications: These pre-planned subset analyses will help refine target populations in future studies of Sildenafil Cream, 3.6% for the treatment of FSAD. Strengths and Limitations: Subset analyses focused on variables pertinent to future target populations. The current study population was primarily educated non-Hispanic White women. Conclusion: Age and hormonal contraceptive use did not impact the efficacy of topical Sildenafil Cream. Daily psychiatric medication use decreased sexual desire in active and placebo users.
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