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

ABSTRACT:

Objective

The objective was to evaluate the contraceptive effectiveness, safety, and acceptability of a novel vaginal pH regulator over seven cycles of use.

Study design

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.

Results

A total of 1384 women were enrolled in the st

SUBMITTER: Thomas MA 

PROVIDER: S-EPMC7358659 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature