At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo Controlled Pilot Study to Determine the Effect and Duration of Acidform Gel on Vaginal pH
In Brief
A Phase 1 clinical trial evaluating Acidform 5 g, Placebo 4 g, and 2 other interventions for Healthy. Completed, enrolled 105 participants across 2 sites.
Detailed Summary
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).
Study Details
Timeline
Interventions
Effect of 5 g vaginally administered Acidform on pH over 7 days
Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
Effect of 4 g vaginally administered Acidform on pH over 7 days
Effect of 3 g vaginally administered Acidform on pH over 7 days