A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain

PHASE3

Phase

TERMINATED

Status

Enrollment

INDUSTRY

Sponsor class

Stopped Study halted due to the significant enrollment challenges encountered since its beginning. Screening and enrollment have been impacted by the COVID pandemic and more importantly by changes in the diagnosis and treatment of women with endometriosis.

Conditions

Endometriosis

Interventions

DRUG: 75 mg linzagolix tablet
DRUG: 200 mg linzagolix tablet
DRUG: Add-back capsule (E2 1 mg / NETA 0.5 mg)
DRUG: Placebo tablet to match 75 mg linzagolix tablet
DRUG: Placebo tablet to match 200 mg linzagolix tablet
DRUG: Placebo capsule to match Add-back capsule

Sponsor

Kissei Pharmaceutical Co., Ltd.