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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 is a Phase 3 study that has completed, run by Daré Bioscience. The registered enrollment target is 307 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04370548
The ClinicalTrials.gov registry entry for NCT04370548 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 307 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daré Bioscience, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which DARE-BV1clindamycin phosphate vaginal gel, 2% is the first listed.
NCT04370548 reports 0 study locations.
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.
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