Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

• Status: Completed
• Trial end date: 2016-04-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

Inclusion Criteria:

• Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)

• Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period

Exclusion Criteria:

• Clinically significant gynecological condition

• Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip

• Plans to become pregnant in the next 18 months