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



Status:Active, not recruiting
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 51
Updated:2/17/2019
Start Date:September 14, 2016
End Date:March 29, 2019

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

This is an extension study for women who have already received six months of treatment in the
phase III clinical trial M12-815 or M12-817, 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.


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.
We found this trial at
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Augusta, Georgia 30909
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Augusta, Georgia 30912
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Austin, Texas 78703
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4000 Old Court Road
Baltimore, Maryland 21208
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200 S Wenona St # 170
Bay City, Michigan 48706
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2416 Esquire Drive
Beavercreek, Ohio 45431
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52 Medical Plaza Drive
Birmingham, Alabama 35235
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Birmingham, Alabama 35235
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Boynton Beach, Florida 33436
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825 Old Lancaster Road
Bryn Mawr, Pennsylvania 19010
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19123 Bloomfield Avenue
Cerritos, California 90703
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Charleston, South Carolina 29425
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Chattanooga, Tennessee 37404
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Chattanooga, Tennessee 37421
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100 E Rivercenter Blvd
Cincinnati, Ohio 45212
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Covington, Louisiana 70433
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Debary, Florida 32713
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Fairhope, Alabama 36532
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Fall River, Massachusetts 02720
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High Point, North Carolina 27262
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Houston, Texas 77030
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Lampasas, Texas 76550
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Richmond, Virginia 23225
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