Conditions: Endometriosis
Keywords: Endometriosis-associated pain Elagolix Gonadotropin-releasing Hormone Antagonist Dysmenorrhea (DYS) Non-menstrual Pelvic Pain (NMPP) Dyspareunia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 496
Healthy volunteers: no

Brief summary:
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis associated pain in adult pre-menopausal women who completed 6 months treatment in pivotal Study M12-671 (NCT01931670).

Detailed description:
The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg once daily (QD) or elagolix 200 mg twice daily (BID) for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.

An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

Arms:
arm 1: Participants received elagolix 150 mg tablets once a day (QD) for 6 months. arm 2: Participants received elagolix 200 mg tablets twice a day (BID) for 6 months.

Interventions: intervention 1: Elagolix
Intervention descriptions: intervention 1: Elagolix tablets administered orally

Protocol document: