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

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

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

Most Recent Events

26 Dec 2019 Planned number of patients changed from 288 to 281.
04 Feb 2019 Results published in the Obstetrics and Gynecology
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.

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