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A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women

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Trial Profile

A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Over 26 Weeks in Postmenopausal Women

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Aug 2024

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At a glance

  • Drugs Elinzanetant (Primary)
  • Indications Hot flashes; Vasomotor symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms OASIS-1
  • Sponsors Bayer

    • Most Recent Events

    • 22 Aug 2024 According to a Bayer media release, data from this study were published in the Journal of the American Medical Association (JAMA).
    • 22 Aug 2024 Results published in a Bayer Media Release.
    • 01 Aug 2024 According to a Bayer media release, a New Drug Application (NDA) for the investigational compound elinzanetant has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.

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