Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04370548 · ClinicalTrials.gov registry record · Phase 3
DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
A Phase 3 study, sponsored by Daré Bioscience.
- Completed
- Registry status
- Phase 3
- Development phase
- 307
- Enrollment target
NCT04370548: Completed Phase 3 study, sponsored by Daré Bioscience.
NCT04370548 is a Phase 3 study that has completed, run by Daré Bioscience. The registered enrollment target is 307 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04370548, a Phase 3 study, has completed, sponsored by Daré Bioscience.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 307 participants
- Enrollment target
Study 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.
Primary Outcome
Clinical cure is defined as: * Resolution of the abnormal vaginal discharge associated with BV; * Negative 10% KOH "whiff test;" and * Clue cells \< 20% of the total epithelial cells in the saline wet mount.
Interventions
- DRUG DARE-BV1clindamycin phosphate vaginal gel, 2%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 3 |
What the finished NCT04370548 record still lists
NCT04370548 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which DARE-BV1clindamycin phosphate vaginal gel, 2% is the first listed.
NCT04370548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04370548 about?
NCT04370548 is a clinical study titled "DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)". 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 point...
What is the current status of trial NCT04370548?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 307 participants. The study started on 2020-06-16. Estimated completion is 2020-12-07.
What interventions are being tested in trial NCT04370548?
The interventions under investigation include: DARE-BV1clindamycin phosphate vaginal gel, 2% (DRUG).
Who is sponsoring clinical trial NCT04370548?
This trial is sponsored by Daré Bioscience, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04370548's enrollment target sits among peer trials
307 1115th of 2000 higher than 886 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05433142 · 307 participants · Phase 1
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
- NCT04162938 · 308 participants · NA
Use of a Patient-Centered Electronic App to Increase ED Patient's Knowledge on HCV to Improve the HCV Care Continuum
- NCT04955795 · 308 participants · NA
Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA
- NCT06090539 · 308 participants · Phase 1
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI