AMPOWER evaluates efficacy of vaginal gel in preventing pregnancy

Three analyses of the phase 3 AMPOWER study evaluated the safety and efficacy of an investigational vaginal pH regulator gel in preventing pregnancy, as well as sexual satisfaction among women receiving the gel.

The results were presented during the virtual American College of Obstetrics and Gynecology Annual Clinical and Scientific Meeting.

“The recently approved vaginal pH modulator, or VPM, trademarked Phexxi, was developed as a novel, nonhormonal, woman-controlled, water-based surfactant-free vaginal gel for prevention of pregnancy,” B. Todd Chappell, MD, a physician at Adams Patterson Gynecology & Obstetrics and the Women’s Care Center of Memphis in Tennessee, said during the presentation of the efficacy results. “VPM has acid-buffering properties and is able to maintain the acidic vaginal environment even in the presence of alkaline semen.”

AMPOWER was a single-arm, open-label confirmatory trial conducted at 112 clinical sites across the United States. In the study, women were asked to administer a single prefilled applicator of VPM intravaginally before intercourse.

Chappell and colleagued conducted a “perfect-use” efficacy analysis of the study. To be included in the analysis, participants must have had a 21- to 35-day cycle, no