DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
Status:
Completed
Trial end date:
2020-12-07
Target enrollment:
Participant gender:
Summary
This is a multicenter, randomized, double-blind, placebo-controlled study of DARE-BV1
(clindamycin phosphate vaginal gel, 2%) (QD x 1 day) compared to placebo vaginal gel (HEC
Universal Placebo Gel) (QD × 1 day) for the treatment of bacterial vaginosis. Patients will
be evaluated at three time points: a Day 1 Screening/Randomization visit, a Day 7-14 Interim
Assessment visit, and a Day 21 - 30 Test of Cure [TOC] visit). Patients who discontinue
prematurely from the study will receive a safety follow-up phone call between Day 21-30. The
total study duration will be approximately one month for each individual patient.