The objective of this study was to determine the magnitude and duration of the reduction in
pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g
compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH was
measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were
assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel (3,
4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).
Phase:
Phase 1
Details
Lead Sponsor:
Evofem Inc.
Collaborators:
Clinical Research Management, Inc. Johns Hopkins University MetroHealth Medical Center