109
Participants
Start Date
April 14, 2016
Primary Completion Date
December 11, 2017
Study Completion Date
December 11, 2017
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.
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.
Duke Human Vaccine Institute - Duke Clinical Vaccine Unit, Durham
University of Iowa - Vaccine Research and Education Unit, Iowa City
Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati
National Institute of Allergy and Infectious Diseases (NIAID)
NIH