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: 10 Aug 2017

At a glance

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

    • 10 Aug 2017 According to a Myovant Sciences media release, this and another phase III trial (CT profile 267068) have been designed to support marketing approval of relugolix in Japan and will be available to Myovant for use as potentially supportive data for approvals in the US and other regions. Top-line results of this trial are expected in the second half of 2017.
    • 01 Jun 2017 Status changed from active, no longer recruiting to completed.
    • 11 Nov 2016 Status changed from recruiting to active, no longer recruiting.
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