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: 13 Feb 2018
At a glance
- Drugs Relugolix (Primary)
- Indications Pain; Uterine leiomyoma
- Focus Registrational; Therapeutic Use
- Sponsors Takeda
- 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.
- 09 Nov 2017 Primary endpoint has been met. (Proportion of participants with a maximum NRS score of 1 or less during the 28 days before the final dose of study drug (Week 12)), as reported in Takeda Media Release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History