Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-associated Pain



Status:Completed
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 50
Updated:1/7/2018
Start Date:May 27, 2014
End Date:May 23, 2017

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Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

A randomized study evaluating the continued safety and efficacy of elagolix in the management
of moderate to severe endometriosis associated pain in adult pre-menopausal female subjects
who completed 6 months treatment in Study M12-671.


Inclusion Criteria:

- Subject has completed the 6-Month Treatment Period in pivotal study M12-671.

- Agrees to use required birth control methods during the study through Month 6 of the
Post-treatment Follow-up period

Exclusion Criteria:

- Clinically significant condition

- Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine,
femoral neck or total hip

- Plans to become pregnant in the next 18 months
We found this trial at
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Winston-Salem, North Carolina 27103
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Albuquerque, New Mexico 87109
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24 Frank Lloyd Wright Drive
Ann Arbor, Michigan 48106
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
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Atlanta, Georgia 30342
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Augusta, Georgia 30912
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10798 West Overland Road
Boise, Idaho 83709
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240 Medical Park Boulevard
Bristol, Tennessee 37620
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450 Clarkson Avenue
Brooklyn, New York 11203
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1700 Abbey Place
Charlotte, North Carolina 28209
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2341 McCallie Avenue
Chattanooga, Tennessee 37404
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5050 palozerde street
Chino, California 91710
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71 East Hollister Street
Cincinnati, Ohio 45219
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Cincinnati, Ohio 45227
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175 South Union Boulevard
Colorado Springs, Colorado 80910
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Columbia, South Carolina 29201
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6122 West Corporate Oaks Drive
Crystal River, Florida 34429
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1912 Alabama 157
Cullman, Alabama 35058
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425 South Cherry Street
Denver, Colorado 80246
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1565 North Main Street
Fall River, Massachusetts 02720
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Fort Wayne, Indiana 46825
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4401 Coit Road
Frisco, Texas 75035
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Grand Rapids, Michigan 49503
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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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4085 University Boulevard South
Jacksonville, Florida 32216
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Jonesboro, Arkansas 72401
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3920 Saint Francis Way
Lafayette, Indiana 47905
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4671 South Congress Avenue
Lake Worth, Florida 33461
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255 Union Boulevard
Lakewood, Colorado 80228
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Little Rock, Arkansas 72204
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1469 Poplar Avenue
Memphis, Tennessee 38104
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Metairie, Louisiana 70001
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Miami, Florida 33144
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Miami, Florida 33176
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14390 Commerce Way
Miami Lakes, Florida 33016
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286 Westward Drive
Miami Springs, Florida 33166
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3 Mobile Infirmary Circle
Mobile, Alabama 36607
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8203 Nigels Drive
Myrtle Beach, South Carolina 29572
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Nashville, Tennessee 37203
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2700 Napoleon Avenue
New Orleans, Louisiana 70115
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New Port Richey, Florida 34653
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880 Kempsville Road
Norfolk, Virginia 23502
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Norwalk, California 90650
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2425 West 22nd Street
Oak Brook, Illinois 60523
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3998 Vista Way
Oceanside, California 92056
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1886 West 800 North
Pleasant Grove, Utah 84062
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Raleigh, North Carolina 27607
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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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San Antonio, Texas 78229
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7940 Floyd Curl Drive
San Antonio, Texas 78229
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San Antonio, Texas 78229
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San Diego, California 92123
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San Diego, California 92123
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11025 North Torrey Pines Road
San Diego, California 92130
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3216 Northeast 45th Place
Seattle, Washington 98105
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Shawnee Mission, Kansas 66218
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145 Applecross Road
Southern Pines, North Carolina 28388
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Southfield, Michigan 48034
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235 East Rowan Avenue
Spokane, Washington 99207
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Staten Island, New York 10306
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3000 Arlington Avenue
Toledo, Ohio 43614
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1111 West 17th Street
Tulsa, Oklahoma 74127
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Washington, District of Columbia 20036
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1015 Medical Center Boulevard
Webster, Texas 77598
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Wellington, Florida 33414
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5950 University Avenue
West Des Moines, Iowa 50266
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603 Village Boulevard
West Palm Beach, Florida 33409
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9300 East 29th Street North
Wichita, Kansas 67226
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1907 Tradd Court
Wilmington, North Carolina 28401
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