Sexual Satisfaction Results with the Vaginal pH Modulator from the Phase 3 AMPOWER Study. Issue 6 (10th April 2022)

• Record Type: Journal Article
• Authors: Thomas, Michael A.; Morlock, Robert; Dart, Clint; Howard, Brandon
• Is Part Of: Journal of sexual medicine. Volume 19:Issue 6(2022)
• Page Start: 975
• Page End: 982
• Publication Date: 2022-04-10
• Subjects: Vaginal pH Modulator -- Sexual Satisfaction -- Non-Hormonal Contraception -- Vaginal Gel; Sexual disorders -- Periodicals; Sex -- Periodicals; Sexual health -- Periodicals; 616.69005
• DOI: 10.1016/j.jsxm.2022.03.221
• Languages: English
• ISSNs: 1743-6095

Abstract

ABSTRACT: Background: The novel vaginal pH modulator (VPM; Phexxi) is a non-hormonal, woman-controlled, on-demand, water-based, surfactant-free contraceptive vaginal gel; VPM has also been cleared by the Food and Drug Administration for use as a personal lubricant. Aim: The aim of this study is to report on sexual satisfaction results from the phase 3 AMPOWER study. Methods: AMPOWER was a single-arm, open-label, multicenter study to assess the safety and efficacy of VPM in preventing pregnancy. Women were enrolled who were healthy, age 18-35 years, and sexually active with regular cyclic menses. Outcomes: Women's satisfaction (including sexual satisfaction) was an exploratory endpoint measured at Baseline and Visits 3-5; sexual satisfaction-related patient reported outcomes (PROs) were assessed via 3 different questions: (i) a question related to the impact on a woman's sex life; (ii) a question from the Sexual Function Questionnaire (SFQ) related to the frequency of ten sexual problems; and (iii) a question from the Female Sexual Function Index (FSFI) related to lubrication. Results: For sexual satisfaction-related PRO measures with baseline assessments, the majority of women reported the same or improved scores at Visit 5 (ranging from 85.8% to 98.4%). The percentage of women who reported that their sex life was improved and/or maintained was higher in Visit 3, 4, and 5 (95.4%, 95.1%, and 93.6%, respectively) compared to Baseline (87.6%). The mean impact on sex life score significantly improved at Visit 5 compared to Baseline ( P < .001). In the SFQ, the mean score significantly improved ( P < .005) at Visit 5 vs Baseline in 7 of the 10 variables measured (vaginal dryness, lack of sexual interest and/or desire, vaginal tightness, pain, anxiety, unable to orgasm, and vaginal bleeding or irritation). In women who reported sexual activity in the last 4 weeks, the mean FSFI score also significantly improved from Baseline to Visit 5 ( P = .037). Clinical Implications: In this post-hoc analysis of the phase 3 AMPOWER study, the PRO results demonstrate a high level of sexual satisfaction with VPM. Strengths and Limitations: The primary strength of this analysis was the large study size of 1, 330 women. Limitations included the non-randomized study design, the post-hoc nature of the analysis, and the fact that sexual satisfaction was an exploratory endpoint. Conclusion: As a non-hormonal, woman-controlled, on-demand, lubricating contraceptive gel, VPM offers women a unique set of benefits with positive impacts on their sexual health.