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
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History