Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)



Status:Completed
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 51
Updated:2/13/2019
Start Date:February 3, 2016
End Date:January 23, 2019

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A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in
combination with estradiol/norethindrone acetate for the management of heavy menstrual
bleeding associated with uterine fibroids in premenopausal women.


Inclusion Criteria:

- Subject is a premenopausal female at the time of Screening.

- Subject has a diagnosis of uterine fibroids documented by a Pelvic Ultrasound (TAU,
TVU).

- Subject has HMB associated with uterine fibroids as evidenced by MBL > 80 mL during
each of two screening menses as measured by the alkaline hematin method.

- Subject has negative urine and/or serum pregnancy test in Screening and just prior to
first dose.

- Subject has an adequate endometrial biopsy performed during Screening, the results of
which show no clinically significant endometrial pathology.

Exclusion Criteria:

- Subject has screening pelvic ultrasound or SIS results that show a clinically
significant gynecological disorder.

- Subject has history of osteoporosis or other metabolic bone disease.

- Subject has clinically significant abnormalities in clinical chemistry, hematology, or
urinalysis.

- Subject has a history of major depression or post-traumatic stress disorder (PTSD)
within 2 years of screening, OR a history of other major psychiatric disorder at any
time (e.g., schizophrenia, bipolar disorder).

- Subject is using any systemic corticosteroids for over 14 days within 3 months prior
to Screening 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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477 Cooper Road
Westerville, Ohio 43081
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Alpharetta, Georgia 30005
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Atlanta, Georgia 30342
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Augusta, Georgia 30909
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Austin, Texas 78703
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4000 Old Court Road
Baltimore, Maryland 21208
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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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19123 Bloomfield Avenue
Cerritos, California 90703
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2341 McCallie Avenue
Chattanooga, Tennessee 37404
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Chicago, Illinois 60637
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Covington, Louisiana 70433
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1395 Alabama 105
Dothan, Alabama 36301
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Encinitas, California 92024
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7540 Cipriano Court
Fairhope, Alabama 36532
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Fort Wayne, Indiana 46825
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100 Fairview Drive
Franklin, Virginia 23851
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1600 Southwest Archer Road
Gainesville, Florida 32610
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1600 Crain Highway South
Glen Burnie, Maryland 21061
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417
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306 West Westwood Avenue
High Point, North Carolina 27262
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Hixson, Tennessee 37343
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Jackson, Tennessee 38305
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Laguna Hills, California 92653
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Lampasas, Texas 76550
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Levittown, Pennsylvania 19056
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Louisville, Kentucky 40291
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Lutherville, Maryland 21093
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Memphis, Tennessee 38104
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Nashville, Tennessee 37203
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New Orleans, Louisiana 70115
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New Port Richey, Florida 34652
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Palos Heights, Illinois 60463
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9501 East Roosevelt Boulevard
Philadelphia, Pennsylvania 19114
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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2630 North Columbia Center Boulevard
Richland, Washington 99352
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9920 Independence Park Drive
Richmond, Virginia 23225
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Richmond, Virginia 23226
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Wellington, Florida 33414
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West Des Moines, Iowa 50266
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