NCT02709005

Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial to Assess the Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Bacterial vaginosis (BV) is a disease of the vagina caused by bacteria. The most common symptom of BV is an abnormal homogeneous off-white vaginal discharge (especially after sex) with an unpleasant smell. This is a Phase II, Double-Blind, Randomized, Placebo-Controlled, Multi-center Trial enrolling 120 women, 18-50 years old, with clinical evidence of bacterial vaginosis. Subjects will be randomized at a ratio of 2:1 to receive active test article (5% Monolaurin Vaginal Gel) or placebo (vehicle) as outpatient therapy. Subjects will be stratified by first time episode of bacterial vaginosis or recurrent bacterial vaginosis. The primary objectives of this study are: 1) To assess the safety and tolerability of 5% Monolaurin Vaginal Gel compared to Vehicle Placebo Gel (excipients only) and 2) To assess the efficacy by clinical cure rate of 5% Monolaurin Vaginal Gel compared to Vehicle Placebo Gel at Visit 2. The secondary objectives are : 1) To evaluate the therapeutic cure rate of 5% Monolaurin Vaginal Gel compared to Vehicle Placebo Gel at Visits 2 and 3, 2) To evaluate the clinical cure rate of 5% Monolaurin Vaginal Gel compared to Vehicle Placebo Gel at Visit 3, 3) To evaluate the changes in Nugent's criteria of vaginal bacterial flora at Visits 2 and 3. This study is expected to last for 13 months, with subject participation duration being 4 weeks.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	5% Monolaurin Vaginal Gel	Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration , and commonly referred to as glycerol monolaurate (GML). Each subject will receive intravaginal gel twice daily for three successive days for a total of 6 doses. There will be 3 clinic visits over 30 days.
OTHER	Placebo	The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Each subject will receive intravaginal gel twice daily for three successive days for a total of 6 doses. There will be 3 clinic visits over 30 days.

Timeline

• Start date: 2016-04-14
• Primary completion: 2017-12-11
• Completion: 2017-12-11
• First posted: 2016-03-15
• Last updated: 2018-12-28
• Results posted: 2018-12-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study