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
92
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8285 West Arby Avenue
Las Vegas, Nevada 89113
877
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Las Vegas, NV
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Albuquerque, New Mexico 87109
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Alpharetta, Georgia 30005
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Alpharetta, Georgia 30005
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
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Atlanta, GA
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1113 Garredd Boulevard
Augusta, Georgia 30909
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8607 East US Highway 36
Avon, Indiana 46123
1858
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Avon, IN
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200 S Wenona St # 170
Bay City, Michigan 48706
1858
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Birmingham, Alabama 35235
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10798 West Overland Road
Boise, Idaho 83709
403
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Boise, ID
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2609 Woolbright Road
Boynton Beach, Florida 33436
2700
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Brandon, FL
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825 Old Lancaster Road
Bryn Mawr, Pennsylvania 19010
2363
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Bryn Mawr, PA
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2125 South Neil Street
Champaign, Illinois 61820
1760
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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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Cincinnati, Ohio 45267
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Clearwater, Florida 33759
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Cleveland, Ohio 44106
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6160 Tutt Boulevard
Colorado Springs, Colorado 80923
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Columbia, South Carolina 29201
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5888 Cleveland Avenue
Columbus, Ohio 43231
2006
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3545 Howard Way
Costa Mesa, California 92626
989
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Covington, Louisiana 70433
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Dallas, TX
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Dayton, OH
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Doral, FL
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Durham, North Carolina 27713
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Fall River, Massachusetts 02720
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13670 Metropolis Avenue
Fort Myers, Florida 33912
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Frederick, Maryland 21708
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Grand Rapids, Michigan 49503
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Greenwood Village, Colorado 80111
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Hawaiian Gardens, California 90716
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500 University Drive
Hershey, Pennsylvania 17033
2293
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7515 Main Street
Houston, Texas 77030
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Kansas City, Kansas 66218
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Kenneth City, Florida 33709
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La Mesa, California 91942
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4671 South Congress Avenue
Lake Worth, Florida 33461
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Las Vegas, Nevada 89128
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Lawrenceville, New Jersey 08648
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Long Beach, California 90806
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2010 Wilshire Boulevard
Los Angeles, California 90057
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12741 Miramar Parkway
Miramar, Florida 33027
2716
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1707 Center Street
Mobile, Alabama 36604
2150
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2201 Murphy Avenue
Nashville, Tennessee 37203
1970
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2700 Napoleon Avenue
New Orleans, Louisiana 70115
2099
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7114 Congress Street
New Port Richey, Florida 34653
2501
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New York, New York 10016
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Newport Beach, California 92663
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825 Fairfax Avenue
Norfolk, Virginia 23507
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North Chesterfield, Virginia 23235
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Oak Brook, Illinois 60523
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114 West Underwood Street
Orlando, Florida 32806
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1200 Breckenridge Street
Owensboro, Kentucky 42303
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Panama City, Florida 32045
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Philadelphia, Pennsylvania 19107
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3401 North Broad Street
Philadelphia, Pennsylvania 19140
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Pittsburgh, Pennsylvania 15206
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Raleigh, North Carolina 27607
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6767 Forest Hill Avenue
Richmond, Virginia 23225
2348
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4118 Pond Hill Road
San Antonio, Texas 78231
1775
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7 Oglethorpe Professional Boulevard
Savannah, Georgia 31406
2403
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3216 Northeast 45th Place
Seattle, Washington 98105
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Shreveport, Louisiana 71118
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324 South Sherman Street
Spokane, Washington 99202
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3000 Arlington Avenue
Toledo, Ohio 43614
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Vienna, Virginia 22182
2308
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110 Irving Street Northwest
Washington, District of Columbia 20010
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Washington, District of Columbia 20036
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603 Village Boulevard
West Palm Beach, Florida 33409
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Westminster, California 92683
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9300 East 29th Street North
Wichita, Kansas 67226
1437
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1907 Tradd Court
Wilmington, North Carolina 28401
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Winston-Salem, North Carolina 27103
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