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

NCT04370548 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2022-12-08

Study results available
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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

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.

Sponsors & Collaborators

  • Daré Bioscience, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2020-11-30
Completion
2020-12-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04370548 on ClinicalTrials.gov