Conditions: Endometriosis
Keywords: Gonadotropin-Releasing Hormone Antagonist Endometriosis associated pain Dysmenorrhea (DYS) Non-Menstrual Pelvic Pain (NMPP) Elagolix
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 872
Healthy volunteers: no

Brief summary:
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.

Detailed description:
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study.

Arms:
arm 1: Elagolix 150 mg once daily (QD) for the 6-month Treatment Period arm 2: Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period arm 3: Placebo BID for the 6-month Treatment Period

Interventions: intervention 1: elagolix intervention 2: placebo
Intervention descriptions: intervention 1: oral tablet intervention 2: oral tablet

Protocol document: