NCT03992846

Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Assess the Efficacy and Safety of Linzagolix in Subjects With Moderate to Severe Endometriosis-associated Pain.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Kissei Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

Detailed description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women. Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	75 mg linzagolix tablet	For oral administration once daily
DRUG	200 mg linzagolix tablet	For oral administration once daily
DRUG	Add-back capsule (E2 1 mg / NETA 0.5 mg)	For oral administration once daily
DRUG	Placebo tablet to match 75 mg linzagolix tablet	For oral administration once daily
DRUG	Placebo tablet to match 200 mg linzagolix tablet	For oral administration once daily
DRUG	Placebo capsule to match Add-back capsule	For oral administration once daily

Timeline

• Start date: 2019-06-13
• Primary completion: 2021-10-18
• Completion: 2022-04-01
• First posted: 2019-06-20
• Last updated: 2025-04-02
• Results posted: 2024-05-29

Locations

71 sites across 10 countries: United States, Austria, Bulgaria, Czechia, France, Hungary, Poland, Romania, Spain, Ukraine

Regulatory

• FDA-regulated drug study