A randomized placebo-controlled pilot study of the effect and duration of Amphora, a multipurpose vaginal pH regulator, on vaginal pH

Abstract

A randomized placebo-controlled pilot study of the effect and duration of Amphora, a multipurpose vaginal pH regulator, on vaginal pH S. Nayak1, A. Avery2, J. McLeod Griffiss3, C.D. Charles1, K.R. Culwell4 1Johns Hopkins Bayview Medical Center, Baltimore, MD 2MetroHealth Medical Center, Cleveland, OH 3Clinical RM, Hinckley, OH 4Evofem, Inc., San Diego, CA (United States) Summary Purpose of Investigation: To determine change in vaginal pH and duration of change with intravaginal administration of single doses of Amphora vaginal gel (AVG). Materials and Methods: This Phase 1, randomized, placebo-controlled, double-blind, multicenter study included 105 women assigned to AVG 5-gram, AVG 4-gram, AVG 3-gram, placebo gel, or no treatment. Results: AVG at any of the three studied doses significantly lowered vaginal pH compared to placebo or no treatment. The effect was most pronounced in subjects with baseline vaginal pH levels ≥ 5. Peak reduction in vaginal pH with AVG occurred at 12 hours post-administration, with the greatest reduction occurring with the AVG 5-g dose. Subjects in the AVG treatment groups continued to have mean reduction in vaginal pH at Day 7 compared with baseline. Conclusion: Reduction from baseline in vaginal pH with 5-g AVG was significantly greater than with placebo or no treatment and persisted to Day 7 post-treatment. Key Words: Bacterial vaginosis; Vaginal pathology; Vaginal pH; Bacterial infections; Genitourinary medicine; Vaginal gel; Contraception; Sexually transmitted infections; Multipurpose vaginal pH regulator; MVP-R.