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Also known as DARE-BV1clindamycin phosphate vaginal gel, 2%
DARE-BV1clindamycin vaginal, 2% · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Clindamycin phosphate vaginal gel, 2% | EXPERIMENTAL | - |
| Placebo vaginal gel (Universal HEC Placebo Gel) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DARE-BV1clindamycin phosphate vaginal gel, 2% | DRUG | 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. |
Inclusion Criteria: 1. Participants must provide written informed consent prior to any study-related procedures being performed. Patients from 12 through 17 years old may participate where permitted by applicable local regulations and Institutional Review Board (IRB) approval and with appropriate d...
DARE-BV1 clindamycin vaginal, 2% is an investigational small molecule therapy being developed for the treatment of bacterial vaginosis. It is a vaginal gel formulation of clindamycin phosphate at a 2% concentration. Dare Bioscience, Inc. is developing the product, which has completed a Phase 3 clinical trial.
DARE-BV1 clindamycin vaginal, 2% is being developed for the treatment of bacterial vaginosis, a common vaginal infection. The clinical program enrolled adolescent and adult female participants aged 12 years and older in the United States. It is an investigational product and is not approved for commercial use.
Dare Bioscience, Inc. is developing DARE-BV1 clindamycin vaginal, 2%. The company trades on the Nasdaq under the ticker DARE. Dare Bioscience is the sponsor of the clinical program evaluating this vaginal gel formulation for bacterial vaginosis.
DARE-BV1 clindamycin vaginal, 2% has completed a Phase 3 clinical trial and remains an investigational product. It has not been approved by the FDA. The Phase 3 study, DARE-BVFREE, was a randomized, double-blind, placebo-controlled trial that enrolled 307 participants.
DARE-BV1 clindamycin vaginal, 2% was evaluated in the Phase 3 DARE-BVFREE trial, registered as NCT04370548. The study was titled DARE-BV1 in the Treatment of Bacterial Vaginosis and was conducted in the United States. It enrolled 307 participants, was randomized, double-blind, and placebo-controlled, and has been completed.
Yes, DARE-BV1 clindamycin vaginal, 2% and DARE-BV1 clindamycin phosphate vaginal gel, 2% refer to the same investigational product from Dare Bioscience. The full name specifies the active ingredient as clindamycin phosphate in a 2% vaginal gel formulation. Both names describe the same asset being studied for bacterial vaginosis.