drugset / Trial / NCT04372121

Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain

NCT04372121

Phase 3 Terminated 30 enrolled Kissei Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2020-03-23
Primary completion
2021-01-08
Completion
2021-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject E2 Unknown 1 mg Oral
Subject NETA Unknown 0.5 mg Oral
Subject linzagolix Unknown 75 mg Oral
Subject linzagolix Unknown 200 mg Oral

Indications