228
Participants
Start Date
June 3, 2016
Primary Completion Date
February 11, 2019
Study Completion Date
February 11, 2019
Lactobacillus crispatus CTV-05
LACTIN-V is an intravaginal live biotherapeutic product composed of Lactobacillus crispatus CTV-05 (LACTIN-V, Osel Inc) in a vaginal applicator. Subjects receive 2x10\^9 cfu/dose applied vaginally daily x 5 days then twice weekly x 10 weeks.
Metronidazole
Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days
Placebo
Placebo formulation applied vaginally, daily x 5 days then twice weekly x 10 weeks.
Cook County Health and Hospitals System - Ruth M Rothstein CORE Center, Chicago
Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit, St Louis
University of California, San Diego - Antiviral Research Center, San Diego
San Francisco General Hospital - Infectious Diseases, San Francisco
National Institute of Allergy and Infectious Diseases (NIAID)
NIH