IMR Press / CEOG / Volume 46 / Issue 5 / DOI: 10.12891/ceog5058.2019

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 as a courtesy and upon agreement with S.O.G.

Open Access Original Research
A randomized placebo-controlled pilot study of the effect and duration of Amphora, a multipurpose vaginal pH regulator, on vaginal pH
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1 Johns Hopkins Bayview Medical Center, Baltimore, MD, United States
2 MetroHealth Medical Center, Cleveland, OH, United States
3 Clinical RM, Hinckley, OH, United States
4 Evofem, Inc., San Diego, CA, United States
*Correspondence: (K. CULWELL)
Clin. Exp. Obstet. Gynecol. 2019, 46(5), 736–742;
Published: 10 October 2019

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.

Bacterial vaginosis
Vaginal pathology
Vaginal pH
Bacterial infections
Genitourinary medicine
Vaginal gel
Sexually transmitted infections
Multipurpose vaginal pH regulator
Figure 1.
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