An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Study Identifier
M12-816
CT.gov Identifier
NCT02925494
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Uterine Fibroids
    • Study Drug
  • Estradiol/Norethindrone Acetate
  • Elagolix
    • Phase
    Phase 3
    Sex
    Female
    Age
    18 - 51 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817). * Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study * Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study. * Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.
    Exclusion Criteria:
    * Participant met criteria for removal from therapy in her respective Pivotal Study. * Participant is planning a pregnancy within the next 18 months. * Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study. * Participant has any new medical conditions that may be unsuitable for participation. * Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.

    Protocol Summary

    This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.

    Study Locations

    Location
    Status
    Location
    Alabama Clinical Therapeutics, LLC /ID# 153217
    Birmingham, Alabama, United States, 35235-3430
    Status
    Not applicable
    Location
    Alabama Clinical Therapeutics, LLC /ID# 153336
    Birmingham, Alabama, United States, 35235-3430
    Status
    Not applicable
    Location
    Choice Research, LLC /ID# 153492
    Dothan, Alabama, United States, 36303
    Status
    Not applicable
    Location
    Brown, Pearson, Guepet Gynecology /ID# 153278
    Fairhope, Alabama, United States, 36532
    Status
    Not applicable
    Location
    University of South Alabama /ID# 153415
    Mobile, Alabama, United States, 36604-3302
    Status
    Not applicable
    Location
    Mobile, Ob-Gyn, P.C. /ID# 153442
    Mobile, Alabama, United States, 36608
    Status
    Not applicable
    Showing {first} - {last} of {total} Results