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A Double-Blind, Randomised, Placebo Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects With Moderate to Severe Vasomotor Symptoms Associated With the Menopause

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Trial Profile

A Double-Blind, Randomised, Placebo Controlled, Adaptive Design Study of the Efficacy, Safety and Pharmacokinetics of NT-814 in Female Subjects With Moderate to Severe Vasomotor Symptoms Associated With the Menopause

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Sep 2024

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At a glance

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

    • Most Recent Events

    • 04 Sep 2024 According to a Bayer media release, The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1).
    • 08 Jan 2024 According to a Bayer media release, the Phase II study NIRVANA is based on improvements in sleep disturbances observed in this Phase IIb study SWITCH-1.
    • 01 Mar 2023 Results published in the Menopause

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