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



Status:Completed
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 51
Updated:2/13/2019
Start Date:December 22, 2015
End Date:December 12, 2018

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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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Clearwater, Florida 33759
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Albuquerque, New Mexico 87109
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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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8607 East US Highway 36
Avon, Indiana 46123
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200 S Wenona St # 170
Bay City, Michigan 48706
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10798 West Overland Road
Boise, Idaho 83709
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2609 Woolbright Road
Boynton Beach, Florida 33436
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825 Old Lancaster Road
Bryn Mawr, Pennsylvania 19010
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2125 South Neil Street
Champaign, Illinois 61820
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Charleston, South Carolina 29425
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Chattanooga, Tennessee 37421
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Chicago, Illinois 60640
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Colorado Springs, Colorado 80923
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Columbia, South Carolina 29201
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5888 Cleveland Avenue
Columbus, Ohio 43231
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3545 Howard Way
Costa Mesa, California 92626
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Fall River, Massachusetts 02720
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13670 Metropolis Avenue
Fort Myers, Florida 33912
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Lake Worth, Florida 33461
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Las Vegas, Nevada 89113
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Miramar, Florida 33027
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Mobile, Alabama 36604
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Nashville, Tennessee 37203
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New Orleans, Louisiana 70115
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New Port Richey, Florida 34653
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Norfolk, Virginia 23507
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Richmond, Virginia 23225
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San Antonio, Texas 78231
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Seattle, Washington 98105
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Wichita, Kansas 67226
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Wilmington, North Carolina 28401
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Winston-Salem, North Carolina 27103
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