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:December 2012
End Date:March 2016

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Trial Summary
Trial Overview
Inclusion Criteria

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 the 6 month treatment period in the pivotal study M12-665.


Inclusion Criteria:

- Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)

- 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
120
sites
Clinical Trial Facility in Denton Texas
Denton, Texas 76210
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Clinical Trial Facility in Akron Ohio
Akron, Ohio
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Clinical Trial Facility in Albuquerque New Mexico
Albuquerque, New Mexico
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Clinical Trial Facility in Ann Arbor Michigan
Ann Arbor, Michigan 48109
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Clinical Trial Facility in Artesia California
Artesia, California 90701
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Clinical Trial Facility in Augusta Georgia
Augusta, Georgia 30912
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Clinical Trial Facility in Avon Indiana
Avon, Indiana 46123
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Avon, IN
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Clinical Trial Facility in Bay City Michigan
Bay City, Michigan 48708
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Clinical Trial Facility in Billings Montana
Billings, Montana 59101
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Clinical Trial Facility in Birmingham Alabama
Birmingham, Alabama
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Clinical Trial Facility in Bluffton South Carolina
Bluffton, South Carolina 29910
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Clinical Trial Facility in Boise Idaho
Boise, Idaho 83712
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Boise, ID
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Clinical Trial Facility in Boynton Beach Florida
Boynton Beach, Florida 33472
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Clinical Trial Facility in Bristol Tennessee
Bristol, Tennessee 37620
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Clinical Trial Facility in Bronx New York
Bronx, New York
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Clinical Trial Facility in Brooklyn New York
Brooklyn, New York 11215
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Clinical Trial Facility in Carmichael California
Carmichael, California 95608
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Clinical Trial Facility in Chandler Arizona
Chandler, Arizona 85224
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Clinical Trial Facility in Charleston West Virginia
Charleston, West Virginia 25304
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Clinical Trial Facility in Charlotte North Carolina
Charlotte, North Carolina 28207
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Clinical Trial Facility in Chaska Minnesota
Chaska, Minnesota 55318
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Clinical Trial Facility in Chattanooga Tennessee
Chattanooga, Tennessee
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Clinical Trial Facility in Chicago Illinois
Chicago, Illinois
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Clinical Trial Facility in Chino California
Chino, California
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Clinical Trial Facility in Cincinnati Ohio
Cincinnati, Ohio
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Clinical Trial Facility in Clearwater Florida
Clearwater, Florida 33756
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Clinical Trial Facility in Colorado Springs Colorado
Colorado Springs, Colorado 80910
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Clinical Trial Facility in Columbus Ohio
Columbus, Ohio 43214
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Clinical Trial Facility in Cullman Alabama
Cullman, Alabama 35058
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Clinical Trial Facility in Debary Florida
Debary, Florida
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Clinical Trial Facility in Denver Colorado
Denver, Colorado
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Clinical Trial Facility in Desoto Texas
Desoto, Texas
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Clinical Trial Facility in Detroit Michigan
Detroit, Michigan
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Clinical Trial Facility in Draper Utah
Draper, Utah
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Clinical Trial Facility in Durham North Carolina
Durham, North Carolina
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Clinical Trial Facility in Edmond Oklahoma
Edmond, Oklahoma 73013
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Clinical Trial Facility in Encinitas California
Encinitas, California 92024
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Clinical Trial Facility in Eugene Oregon
Eugene, Oregon 97404
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Clinical Trial Facility in Fort Lauderdale Florida
Fort Lauderdale, Florida
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Clinical Trial Facility in Fort Myers Florida
Fort Myers, Florida 33916
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Clinical Trial Facility in Fort Worth Texas
Fort Worth, Texas
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Clinical Trial Facility in Frederick Maryland
Frederick, Maryland 21702
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Clinical Trial Facility in Frisco Texas
Frisco, Texas 75035
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Clinical Trial Facility in Gainesville Florida
Gainesville, Florida 32610
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Clinical Trial Facility in Goodyear Arizona
Goodyear, Arizona 85395
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Clinical Trial Facility in Grand Rapids Michigan
Grand Rapids, Michigan 49503
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Clinical Trial Facility in Granger Indiana
Granger, Indiana 46530
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Clinical Trial Facility in Greensboro North Carolina
Greensboro, North Carolina 27401
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Clinical Trial Facility in Greenville South Carolina
Greenville, South Carolina 29605
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Clinical Trial Facility in Groton Connecticut
Groton, Connecticut 06340
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Clinical Trial Facility in Hamilton
Hamilton,
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Clinical Trial Facility in Hialeah Florida
Hialeah, Florida
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Clinical Trial Facility in Houston Texas
Houston, Texas
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Clinical Trial Facility in Idaho Falls Idaho
Idaho Falls, Idaho
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Clinical Trial Facility in Irving Texas
Irving, Texas 75062
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Clinical Trial Facility in Jackson Tennessee
Jackson, Tennessee 38305
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Clinical Trial Facility in Jenkintown Pennsylvania
Jenkintown, Pennsylvania 19046
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Clinical Trial Facility in Jersey City New Jersey
Jersey City, New Jersey 07306
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Clinical Trial Facility in La Crosse Wisconsin
La Crosse, Wisconsin 54601
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Clinical Trial Facility in La Jolla California
La Jolla, California 92093
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Clinical Trial Facility in Lakewood Colorado
Lakewood, Colorado 80228
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Clinical Trial Facility in Las Vegas Nevada
Las Vegas, Nevada 89135
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Clinical Trial Facility in Lexington Kentucky
Lexington, Kentucky
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Clinical Trial Facility in Lincoln Nebraska
Lincoln, Nebraska 68515
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Clinical Trial Facility in Little Rock Arkansas
Little Rock, Arkansas
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Clinical Trial Facility in Lonetree Colorado
Lonetree, Colorado 80124
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Clinical Trial Facility in Longview Texas
Longview, Texas 75605
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Clinical Trial Facility in Los Angeles California
Los Angeles, California
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Clinical Trial Facility in Marrero Louisiana
Marrero, Louisiana 70072
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Clinical Trial Facility in Mayfield Heights Ohio
Mayfield Heights, Ohio 44124
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Clinical Trial Facility in Medford Oregon
Medford, Oregon 97504
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Clinical Trial Facility in Memphis Tennessee
Memphis, Tennessee
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Clinical Trial Facility in Miami Florida
Miami, Florida 33136
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Clinical Trial Facility in Middleton Wisconsin
Middleton, Wisconsin 53562
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Clinical Trial Facility in Minot North Dakota
Minot, North Dakota 58701
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Clinical Trial Facility in Mobile Alabama
Mobile, Alabama
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Clinical Trial Facility in Myrtle Beach South Carolina
Myrtle Beach, South Carolina 29572
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Clinical Trial Facility in New Bern North Carolina
New Bern, North Carolina 28560
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Clinical Trial Facility in New London Connecticut
New London, Connecticut 06320
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Clinical Trial Facility in New Orleans Louisiana
New Orleans, Louisiana
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Clinical Trial Facility in New Port Richey Florida
New Port Richey, Florida 34652
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Clinical Trial Facility in New York New York
New York, New York 10032
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Clinical Trial Facility in Norfolk Virginia
Norfolk, Virginia 23507
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Clinical Trial Facility in North Charleston South Carolina
North Charleston, South Carolina 29406
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Clinical Trial Facility in North Miami Florida
North Miami, Florida 33161
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Clinical Trial Facility in Oak Brook Illinois
Oak Brook, Illinois 60523
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Clinical Trial Facility in Omaha Nebraska
Omaha, Nebraska
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Clinical Trial Facility in Owensboro Kentucky
Owensboro, Kentucky 42303
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
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Clinical Trial Facility in Phoenix Arizona
Phoenix, Arizona
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Clinical Trial Facility in Pittsburgh Pennsylvania
Pittsburgh, Pennsylvania
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Clinical Trial Facility in Plantation Florida
Plantation, Florida 33317
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Clinical Trial Facility in Pleasant Grove Utah
Pleasant Grove, Utah 84062
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Clinical Trial Facility in Port Jefferson New York
Port Jefferson, New York 11777
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Clinical Trial Facility in Portland Oregon
Portland, Oregon
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Clinical Trial Facility in Raleigh North Carolina
Raleigh, North Carolina 27607
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Clinical Trial Facility in Renton Washington
Renton, Washington 98057
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Clinical Trial Facility in Richmond Virginia
Richmond, Virginia 23227
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Clinical Trial Facility in Riverton Utah
Riverton, Utah 84065
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Clinical Trial Facility in Saginaw Michigan
Saginaw, Michigan 48604
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