(093) impact of enrollment diagnosis on efficacy endpoints in an exploratory, phase 2B, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder
Abstract
There are no FDA-approved treatments for female sexual arousal disorder (FSAD). Women with FSAD also often have co-existing secondary female sexual dysfunction (FSD) diagnoses.
Post-hoc subset analysis of the effect of enrollment FSD diagnoses on efficacy 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). The change from baseline at week 12 in the arousal sensation (AS) domain (questions 6-9) of the 28-question sexual function questionnaire (SFQ28) was a co-primary efficacy endpoint. Changes from baseline in the mean number of satisfactory sexual experiences (SSEs) was a secondary endpoint. Exploratory efficacy endpoints included the Desire and Orgasm domains of the SFQ28. Enrollment FSD diagnoses were established during a clinical interview with independent experts. A retrospective review was performed of the clinical interviews for the intent-to-treat (ITT) population who completed the study (n=174) and enrollment diagnoses were categorized.
Table 1 shows the breakdown of enrollment diagnoses by product group for the ITT population. Participants with FSAD and pain (n=6) were excluded. Although few women had FSAD as their sole diagnosis, when randomized to Sildenafil Cream, 3.6%, they had the largest mean increases in efficacy variables at week 12. Women with FSAD and secondary HSDD also experienced substantial benefit with…
How strong is the evidence?
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. Reported size: 174 participants or records.
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