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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2017

At a glance

  • Drugs Relugolix (Primary) ; Leuprorelin
  • Indications Uterine leiomyoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda
  • Most Recent Events

    • 03 Oct 2017 According to a Takeda media release, the company plans to submit the results from the trial to regulatory authorities in Japan for marketing authorization of relugolix for the treatment of uterine fibroids.
    • 03 Oct 2017 Primary endpoint has been met. (Proportion of participants with a total Pictorial Blood Loss Assessment Chart (PBAC) score of 10 (from Week 6 to 12)), according to a Takeda media release.
    • 03 Oct 2017 Results published in a Takeda media release.
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