NCT04370548

DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)

A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Daré Bioscience, Inc. · Industry
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	DARE-BV1clindamycin phosphate vaginal gel, 2%	One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) or placebo gel will be applied intravaginally as a single dose within 1 day of randomization.

Timeline

• Start date: 2020-06-16
• Primary completion: 2020-11-30
• Completion: 2020-12-07
• First posted: 2020-05-01
• Last updated: 2022-12-08
• Results posted: 2021-07-02

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study