Clinical and Experimental Obstetrics & Gynecology (CEOG) is published by IMR Press from Volume 47 Issue 1 (2020). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement with S.O.G.
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.