Conditions: Endometriosis
Keywords: Endometriosis associated pain Elagolix Gonadotropin-Releasing Hormone Antagonist Dysmenorrhea (DYS) Non-Menstrual Pelvic Pain (NMPP)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 506
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 pre-menopausal women.

Detailed description:
This is a Phase 3 multicenter, double blind randomized study to assess the continued safety and efficacy of the 150 mg once daily (QD) and 200 mg twice daily (BID) doses of elagolix in premenopausal women with moderate to severe endometriosis-associated pain who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). 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 QD or elagolix 200 mg 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.

All participants who prematurely discontinued treatment (unless pregnant or elected surgery for endometriosis) or completed the 6-month Treatment Period in this extension study were to enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.

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: