DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)
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.
Timeline
- Start
- 2020-06-16
- Primary completion
- 2020-11-30
- Completion
- 2020-12-07
Outcome
Met primary endpoint
paper 70.5% of patients in the clindamycin group and 35.6% in the placebo group achieved clinical cure at test of cure (primary outcome) PMID 35675606 ↗
paper difference of 34.9, 95% CI 19.0-50.8 PMID 35675606 ↗
Publications
- Mauck C, Hillier SL, Gendreau J, Dart C, Wu H, Chavoustie S, Sorkin-Wells V, Nicholson-Uhl CS, Perez B, Jacobs M, Zack N, Friend D. Acceptability of Single-dose Clindamycin Gel for Bacterial Vaginosis: A Randomized Controlled Trial. Clin Ther. 2023 May;45(5):415-425. doi: 10.1016/j.clinthera.2023.04.001. Epub 2023 Apr 23.
- Mauck C, Hillier SL, Gendreau J, Dart C, Chavoustie S, Sorkin-Wells V, Nicholson-Uhl C, Perez B, Jacobs M, Zack N, Friend D. Single-Dose, Bioadhesive Clindamycin 2% Gel for Bacterial Vaginosis: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1092-1102. doi: 10.1097/AOG.0000000000004805. Epub 2022 May 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clindamycin | Unknown | 100 mg | — |