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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 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 to treat bacterial vaginosis, a common vaginal infection. The development program targets this infectious disease indication in female patients aged 12 years and older. It is an investigational product and has not been approved by the FDA.
Dare Bioscience, Inc., which trades under the ticker DARE, is the developer of DARE-BV1 clindamycin vaginal, 2%. The company is advancing the product as a vaginal gel formulation of clindamycin phosphate 2% 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, enrolled 307 participants and has been completed.
DARE-BV1 clindamycin vaginal, 2% was studied in the Phase 3 DARE-BVFREE trial, registered as NCT04370548. The trial evaluated the product in bacterial vaginosis, enrolled 307 participants, and was randomized, double-blind, and placebo-controlled. It was conducted in the United States in female participants aged 12 years and older, and it 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, Inc. Both names describe the 2% clindamycin phosphate vaginal gel being developed for bacterial vaginosis.