Conditions: Endometriosis
Keywords: Non-Menstrual Pelvic Pain (NMPP) Dysmenorrhea (DYS) Elagolix Endometriosis Associated Pain Gonadotropin-Releasing Hormone Antagonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 815
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 subjects.

Detailed description:
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. Subjects will be required to use nonhormonal dual contraception during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.

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

Interventions: intervention 1: placebo intervention 2: Elagolix
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: