A Phase II randomized, double-blind, placebo-controlled study screening approximately 600
adult females, aged 18-55, with a goal to enroll approximately 250 participants to achieve
200 evaluable participants at the test of cure (TOC) visit. The study is designed to
determine the clinical efficacy of an investigational product (IP), TOL-463 Insert, in
suppressing Recurrent Bacterial Vaginosis (RBV) when administered to women who have a history
of RBV and have been successfully cleared of their current Bacterial Vaginosis (BV) infection
administering 500 mg of oral metronidazole, twice a day for 7 days or another CDC-recommended
BV treatment. Patient participation will be approximately 100 days while the study is
conducted at 4 sites within the United States. The primary objective of the study is to
evaluate the clinical efficacy of a twice-weekly application of TOL-463 vaginal insert in
suppression of BV in women with a history of RBV following successful induction with oral
metronidazole or a CDC-recommended BV treatment.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)