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

Phase 3 Completed 281 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of Relugolix (TAK-385) 40 mg administered orally once daily for 12 weeks, compared with leuprorelin injection (once every 4 weeks, 1.88 mg or 3.75 mg subcutaneously \[SC\]/time) in patients with uterine fibroids.

Timeline

Start: 2016-03-05
Primary completion: 2017-05-17
Completion: 2017-09-25

Outcome

Met primary endpoint

paper demonstrating noninferiority of relugolix compared with leuprorelin (relugolix-leuprorelin difference -0.9%; 95% CI: -10.10 to 8.35; PMID 30741797 ↗

paper prespecified noninferiority margin -15%; P=.001). PMID 30741797 ↗

Publications

Osuga Y, Enya K, Kudou K, Tanimoto M, Hoshiai H. Oral Gonadotropin-Releasing Hormone Antagonist Relugolix Compared With Leuprorelin Injections for Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):423-433. doi: 10.1097/AOG.0000000000003141.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Leuprolide	Other / unclassified	1.88 mg	Subcutaneous
Comparator	Leuprolide	Other / unclassified	3.75 mg	Subcutaneous
Subject	Relugolix	Small molecule	40 mg	Oral