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
Phase of Trial: Phase III
Latest Information Update: 10 Aug 2017
At a glance
- Drugs Relugolix (Primary)
- Indications Pain; Uterine leiomyoma
- Focus Registrational; Therapeutic Use
- Sponsors Takeda
- 10 Aug 2017 According to a Myovant Sciences media release, this and another phase III trial (CT profile 267070) 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.
- 09 Jun 2017 Planned End Date changed from 1 Jun 2017 to 2 Jun 2017.
- 01 Jun 2017 Status changed from active, no longer recruiting to completed.