NCT02655237View on ClinicalTrials.gov

A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

PHASE3CompletedINTERVENTIONAL

Enrollment

281

Participants

Timeline

Start Date

March 5, 2016

Primary Completion Date

May 17, 2017

Study Completion Date

September 25, 2017

Conditions

Uterine Fibroids

Interventions

DRUG

Relugolix

Relugolix tablets

DRUG

Relugolix Placebo

Relugolix placebo-matching tablets

DRUG

Leuprorelin

Leuprorelin injection

DRUG

Leuprorelin Placebo

Leuprorelin placebo-matching injections

Trial Locations (25)

Unknown

Nagoya

Matsudo

Kouriyama

Ebetsu

Sapporo

Kako-gun

Nishinomiya

Kawasaki

Yamato

Yokohama

Ibaraki

Sakai

Suita

Yao

Bunkyo-ku

Chiyoda-ku

Chuou-ku

Minato-ku

Setagaya-ku

Suginami-ku

Taitou-ku

Kagoshima

Kyoto

Osaka

Saitama

Sponsors

Lead Sponsor

All Listed Sponsors

lead

Takeda

INDUSTRY