At a glance
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A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With 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 356 participants across 47 sites in 9 countries.
Detailed Summary
The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.
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