Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis
Status:
Completed
Trial end date:
2017-12-11
Target enrollment:
Participant gender:
Summary
This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial
enrolling 120 subjects with Bacterial Vaginosis who will be randomized at a ratio of 2:1 to
receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle). The primary
objective is to assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to
vehicle placebo gel (excipients only) and to assess the efficacy by clinical cure rate of 5%
Monolaurin Vaginal Gel compared to vehicle placebo gel at Visit 2.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)