NCT05648669

A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain.

Detailed description

This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. Participants will be randomised in a 1:1 ratio to receive either elagolix ( 200mg )or placebo. Participants will be administered the study drug up to month 6.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Elagolix	200 mg tablet
DRUG	Elagolix placebo	Elagolix-matched Placebo tablet

Timeline

• Start date: 2022-09-04
• Primary completion: 2023-07-01
• Completion: 2024-02-01
• First posted: 2022-12-13
• Last updated: 2022-12-13

Locations

1 site across 1 country: China