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A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis

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Trial Profile

A Phase 3 Multi-Center, Double-Blind, Placebo-Controlled, Randomized Study of DARE-BV1 in the Treatment of Bacterial Vaginosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Apr 2023

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At a glance

  • Drugs Clindamycin (Primary)
  • Indications Bacterial vaginosis
  • Focus Registrational; Therapeutic Use
  • Acronyms DARE-BVFREE
  • Sponsors Dare Bioscience

    • Most Recent Events

    • 23 Apr 2023 Results assessing acceptability of a single-dose bioadhesive 2% clindamycin vaginal gel for bacterial vaginosis published in the Clinical Therapeutics
    • 01 Jun 2022 Results published in the Obstetrics and Gynecology
    • 07 Dec 2021 According to a Dare Bioscience media release, the U.S. Food and Drug Administration (FDA) approved XACIATO (clindamycin phosphate vaginal gel, 2%) (formerly known as DARE-BV1) for the treatment of bacterial vaginosis in females 12 years of age and older, based on data from this trial.

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