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

PHASE2CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

April 14, 2016

Primary Completion Date

December 11, 2017

Study Completion Date

December 11, 2017

Conditions
Bacterial Vaginosis
Interventions
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.

Trial Locations (3)

27704

Duke Human Vaccine Institute - Duke Clinical Vaccine Unit, Durham

52242-2600

University of Iowa - Vaccine Research and Education Unit, Iowa City

45229-3039

Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02709005 - Safety and Efficacy of 5% Monolaurin Vaginal Gel Administered Intravaginally for the Treatment of Bacterial Vaginosis | Biotech Hunter | Biotech Hunter