At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating 75 mg linzagolix tablet, 200 mg linzagolix tablet, and 4 other interventions for Endometriosis. Completed, enrolled 486 participants across 71 sites in 10 countries.
Detailed 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).
Study Details
Timeline
Interventions
For oral administration once daily
For oral administration once daily
For oral administration once daily
For oral administration once daily
For oral administration once daily
For oral administration once daily