Sexual Satisfaction Results With the Vaginal pH Modulator From the Phase 3 AMPOWER Study

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. Thomas MA, Morlock R, Dart C, Howard B. Sexual Satisfaction Results With the Vaginal pH Modulator From the Phase 3 AMPOWER Study. J Sex Med 2022;19:975-982.

Trial registration: ClinicalTrials.gov NCT04553068.

Keywords: Non-Hormonal Contraception; Sexual Satisfaction; Vaginal Gel; Vaginal pH Modulator.