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Clinical and Experimental Obstetrics & Gynecology  2019, Vol. 46 Issue (5): 736-742    DOI: 10.12891/ceog5058.2019
Original Research Previous articles | Next articles
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, United States
2MetroHealth Medical Center, Cleveland, OH, United States
3Clinical RM, Hinckley, OH, United States
4Evofem, Inc., San Diego, CA, United States
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Abstract  

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     
Published:  10 October 2019     
*Corresponding Author(s):  K. CULWELL     E-mail:  kculwell@evofem.com

Cite this article: 

S. Nayak, A. Avery, J. McLeod Griffiss, C.D. Charles, K.R. Culwell. A randomized placebo-controlled pilot study of the effect and duration of Amphora, a multipurpose vaginal pH regulator, on vaginal pH. Clinical and Experimental Obstetrics & Gynecology, 2019, 46(5): 736-742.

URL: 

https://ceog.imrpress.com/EN/10.12891/ceog5058.2019     OR     https://ceog.imrpress.com/EN/Y2019/V46/I5/736

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