DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
Public ClinicalTrials.gov record NCT04370548. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04370548
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 307 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 15, 2020
- Primary completion
- Nov 29, 2020
- Completion
- Dec 6, 2020
- Last update posted
- Dec 7, 2022
2020
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vision Clinical Research-Tuscon | Tucson | Arizona | 85712 | — |
| Downtown Women's Health Care | Denver | Colorado | 80209 | — |
| New Age Medical Research Corporation | Miami | Florida | 33186 | — |
| Precision Clinical Research, LLC | Sunrise | Florida | 33351 | — |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | — |
| NuDirections Clinical Research, Inc. | Lawrenceville | Georgia | 30044 | — |
| Capital Health-Lawrence OB/GYN | Lawrenceville | New Jersey | 08648 | — |
| The Center for Women's Health & Wellness, LLC | Lawrenceville | New Jersey | 08684 | — |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04370548, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 7, 2022 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04370548 live on ClinicalTrials.gov.