Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

Study Identifier
M12-821
CT.gov Identifier
NCT02143713
EudraCT Identifier
2013-001047-31
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Endometriosis
    • Study Drug
  • Elagolix
    • Phase
    Phase 3
    Sex
    Female
    Age
    18 - 50 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject has completed the 6-Month Treatment Period in pivotal study M12-671. * 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

    Protocol 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).

    Study Locations

    No locations found.