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Industry Abstract

OFFICE PRACTICE

Impact of Age, Race, and Medication on Efficacy Endpoints in Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial of Sildenafil Cream for Female Sexual Arousal Disorder Treatment. - IP03-D

Saturday, May 18, 2024
1:15 PM - 2:15 PM PDT
Location: Hall C
Authors:
Katherine Cornell BS; Jessica Hatheway MBA; David Friend PhD; Andrew Goldstein MD

Introduction:

Efficacy of treatments for female sexual arousal disorder (FSAD) and other female sexual dysfunction (FSD) diagnoses may be impacted by various demographic and medical history variables.

Methods:

Phase 2b, exploratory, randomized, placebo-controlled, double-blind study of Sildenafil Cream, 3.6% among premenopausal women with FSAD. Co-primary efficacy endpoints were change from baseline in the arousal sensation (AS) domain of the sexual function questionnaire (SFQ28) and question 14 (Q14) of the female sexual distress scale desire orgasm arousal (FSDS-DAO) survey. Secondary efficacy endpoints were change from baseline in mean number and proportion of satisfactory sexual experiences (SSEs). Exploratory efficacy endpoints included the SFQ28 desire, orgasm and arousal lubrication (AL) domains. The impact of enrollment FSD diagnosis, age, race, hormonal contraception and daily psychiatric medication use on efficacy endpoints was assessed. NCT04948151.

Results:

Co-primary endpoint scores were not impacted (p values>0.12) by age group (≥18 and ≤45 versus >45 years), race (white versus non-white), or hormonal contraception use. Non-white women had significantly more SSEs with Sildenafil Cream,3.6% than Placebo use (p=0.017). Daily psychiatric medication use among women using either Placebo or Sildenafil Cream,3.6% resulted in significantly lower SFQ28 Desire domain scores (p=0.03) at week 8 compared to non-users of daily psychiatric medications. Women whose sole FSD diagnosis was FSAD had a significant increase in the co-primary endpoint of the SFQ28 AS domain with sildenafil use (p=0.048). Conclusion/Implications:

These pre-planned subset analyses will be used in planning future studies of topical sildenafil for FSAD to maximize treatment benefit among women with this common FSD diagnosis.
Disclosure(s):
Andrea Ries Thurman, MD: No financial relationships to disclose
Katherine Cornell, BS: Clinical Outcome Solutions: Consultant (Ongoing); Dare Bioscience: Consultant (Ongoing); Strategic Science & Technologies, LLC: Employee (Ongoing)
Jessica Hatheway, MBA: Daré Bioscience, Inc.: Employee (Ongoing)
David R. Friend, PhD: No financial relationships to disclose
Andrew T. Goldstein, MD: AbbVie: Consultant (Ongoing); Daré Bioscience: Employee (Ongoing), Stock Shareholder (excluding mutual funds) (Ongoing); Incyte: Advisory Committee/Board Member (Ongoing), Grant/Research Support (Ongoing)