This Phase 2b trial is designed to provide a screening evaluation for the hypothesis that,
following a 5-day treatment with MetroGel® to treat BV, L. crispatus CTV-05 (LACTIN-V, Osel,
Inc.) administered at 2 x 10^9 cfu/dose using a vaginal applicator reduces the 12-week
incidence of BV recurrence when compared to placebo. The primary objectives of this study
are: 1) To estimate the efficacy of repeated doses of LACTIN-V (2 x 10^9 cfu/dose) as
compared to placebo in preventing BV recurrence by 12 weeks following treatment of BV with
MetroGel vaginal gel (MetroGel). 2) To assess the safety of LACTIN-V over 24 weeks by
comparing the incidence of AEs between individuals randomized to LACTIN-V or placebo.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)