A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Phase 3 Completed 287 enrolled Kissei Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia

Timeline

Start: 2022-10-11
Primary completion: 2024-08-21
Completion: 2024-08-21

Outcome

Met primary endpoint

paper This phase 3 study met its primary endpoint PMID 42406777 ↗

paper which was non-inferior to 90.8% (84.7, 95.0) in the leuprorelin group (difference, -0.9% [-8.6, 6.9]). PMID 42406777 ↗

Publications

Osuga Y, Harada T, Takahashi H, Kawai A, Shimamura F; KLH2301 Investigators. Linzagolix versus leuprorelin in Japanese women with uterine leiomyomas: a phase 3, randomized, active-controlled, non-inferiority trial. Hum Reprod. 2026 Jul 6:deag106. doi: 10.1093/humrep/deag106. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KLH-2109	Unknown	200 mg	Oral
Comparator	Leuprolide	Other / unclassified	1.88 mg	Subcutaneous