A novel vaginal pH regulator: results from the phase 3 AMPOWER contraception clinical trial

Contraception: X
Michael A ThomasBrandon Howard

Abstract

The objective was to evaluate the contraceptive effectiveness, safety, and acceptability of a novel vaginal pH regulator over seven cycles of use. A single-arm, open-label, phase 3 study was conducted across 112 sites in the United States in sexually active 18-35-year-old women at risk of pregnancy. Women administered the study treatment ≤ 1 h before each episode of intercourse. Women recorded use of study drug, coital information, and any symptoms experienced in electronic diaries. The primary outcome was the seven-cycle cumulative pregnancy rate as calculated using the Kaplan-Meier methodology; secondary outcomes included safety. Overall satisfaction was assessed via written questionnaires. A total of 1384 women were enrolled in the study from July 2017 to November 2018. Mean age was 27.7 ± 4.4 years; most women were white (69.0%). The seven-cycle cumulative pregnancy percentage was 13.7% [95% confidence interval (CI): 10.0%-17.5%], meeting the prespecified primary endpoint of having the upper bound 95% CI ≤ 21%. Most common adverse events (AEs) occurring in ≥ 2% of women were vulvovaginal burning sensation, vulvovaginal pruritus, urinary tract infection, vulvovaginal pain, mycotic infection, bacterial vaginosis, and nasophar...Continue Reading

Citations

Sep 25, 2020·Current Opinion in Obstetrics & Gynecology·Erica P Cahill, Simranvir Kaur
Mar 3, 2021·Nursing for Women's Health·Jeanann Sousou Coppola
Oct 12, 2020·Biochemical Pharmacology·Bianca N QuadeRossana Occhipinti

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Methods Mentioned

BETA
pregnancy test
contraception
pregnancy tests

Clinical Trials Mentioned

NCT03243305

Software Mentioned

AMPOWER
MedDRA
SAS®

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