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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North Chesterfield, Virginia 23235
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North Chesterfield, VA
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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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Alpharetta, Georgia 30005
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Atlanta, GA
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1113 Garredd Boulevard
Augusta, Georgia 30909
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1120 15th Street
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
1933
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Bay City, MI
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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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52 Medical Plaza Drive
Birmingham, Alabama 35235
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2609 Woolbright Road
Boynton Beach, Florida 33436
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Brandon, FL
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Brooklyn, NY
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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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2341 McCallie Avenue
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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Clearwater, Florida 33759
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Cleveland, OH
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College Park, Georgia 30349
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Columbia, South Carolina 29201
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7043 Highway 190 East Service Road
Covington, Louisiana 70433
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Covington, Louisiana 70433
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Dallas, TX
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609 North Charles Richard Beall Boulevard
Debary, Florida 32713
2180
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Dothan, Alabama 36303
1900
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Durham, North Carolina 27713
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Encinitas, California 92024
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7540 Cipriano Court
Fairhope, Alabama 36532
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373 New Boston Road
Fall River, Massachusetts 02720
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Fall River, Massachusetts 02720
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Fort Lauderdale, Florida 33316
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Fort Worth, Texas 76104
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Greensboro, NC
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Greenwood Village, Colorado 80111
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500 University Drive
Hershey, Pennsylvania 17033
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306 West Westwood Avenue
High Point, North Carolina 27262
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7515 Main Street
Houston, Texas 77030
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Jacksonville, Florida 32256
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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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207 West Avenue East
Lampasas, Texas 76550
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Las Vegas, Nevada 89117
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8285 West Arby Avenue
Las Vegas, Nevada 89113
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Las Vegas, Nevada 89128
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Lawrenceville, New Jersey 08648
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5512 Bardstown Road
Louisville, Kentucky 40291
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Memphis, Tennessee 38104
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Meridian, Idaho 83646
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Miami Lakes, Florida 33016
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1707 Center Street
Mobile, Alabama 36604
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Mobile, Alabama 36608
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2201 Murphy Avenue
Nashville, Tennessee 37203
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New Bern, North Carolina 28562
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2700 Napoleon Avenue
New Orleans, Louisiana 70115
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5604 Gulf Drive
New Port Richey, Florida 34652
2114
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7114 Congress Street
New Port Richey, Florida 34653
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New York, New York 10016
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Norfolk, Virginia 23502
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Norfolk, Virginia 23507
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Norwalk, California 90650
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Oak Brook, Illinois 60523
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114 West Underwood Street
Orlando, Florida 32806
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Panama City, Florida 32045
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Philadelphia, Pennsylvania 19104
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9501 East Roosevelt Boulevard
Philadelphia, Pennsylvania 19114
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Plantation, Florida 33324
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Raleigh, North Carolina 27607
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3100 Duraleigh Road
Raleigh, North Carolina 27612
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9920 Independence Park Drive
Richmond, Virginia 23225
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6767 Forest Hill Avenue
Richmond, Virginia 23225
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Saint Cloud, Florida 34769
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7940 Floyd Curl Drive
San Antonio, Texas 78229
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Savannah, Georgia 31406
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