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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 is used for the treatment of bacterial vaginosis, a common vaginal infection. It is a small molecule drug being developed as a 2% clindamycin vaginal formulation. The drug is currently in Phase 3 clinical development and is being studied in female patients aged 12 years and older.
DARE-BV1 contains clindamycin, an antibiotic that targets bacterial infections. It is designed to treat bacterial vaginosis by delivering clindamycin directly to the vaginal area. The drug is being evaluated in a Phase 3 clinical trial for its efficacy and safety in treating this condition.
DARE-BV1 is being developed by Dare Bioscience, Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol DARE. Dare Bioscience is conducting clinical trials to evaluate the safety and efficacy of DARE-BV1 for the treatment of bacterial vaginosis.
DARE-BV1 is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial, known as DARE-BVFREE, has been completed, and the results will inform potential regulatory submissions for approval.
DARE-BV1 has been studied in a Phase 3 clinical trial with the identifier NCT04370548, titled "DARE-BV1 in the Treatment of Bacterial Vaginosis (DARE-BVFREE)." This randomized, double-blind, placebo-controlled trial enrolled 307 female participants in the United States and has been completed.
DARE-BV1 is a formulation of clindamycin, specifically a 2% vaginal preparation. It is being developed by Dare Bioscience for the treatment of bacterial vaginosis. While clindamycin is the active ingredient, DARE-BV1 represents a specific proprietary formulation being tested in clinical trials.