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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-385 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids

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Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-385 40 mg in the Treatment of Pain Symptoms Associated With Uterine Fibroids

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Relugolix (Primary)
  • Indications Pain; Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda

Most Recent Events

  • 06 Oct 2019 Safety and efficacy results published in the Fertility and Sterility.
  • 13 Feb 2018 According to a Myovant Sciences media release, Takeda plans to submit the results from the trial to regulatory authorities in Japan for marketing authorization of relugolix for the treatment of uterine fibroids.
  • 09 Nov 2017 Results published in a Myovant Sciences media release.

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