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A single arm, open-label, Phase 3 study of Ovaprene for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause in women with intact uteri

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Trial Profile

A single arm, open-label, Phase 3 study of Ovaprene for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause in women with intact uteri

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 May 2025

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At a glance

  • Drugs Estradiol/progesterone (Primary)
  • Indications Vasomotor symptoms
  • Focus Registrational; Therapeutic Use
  • Sponsors Dare Bioscience

Most Recent Events

  • 13 May 2025 According to a Dare Bioscience media release, Dare expects the study to support the submission of a premarket approval application for Ovaprene to the FDA, as well as regulatory filings in Europe and other countries worldwide, to allow for marketing approvals of Ovaprene.
  • 13 May 2025 According to a Dare Bioscience media release, $10.7 million foundation non-dilutive grant announced in November 2024 supported addition of 5 new investigator sites in the first quarter of 2025.
  • 13 May 2025 According to a Dare Bioscience media release, data safety monitoring board interim assessment scheduled for July 2025

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