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 |
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.
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
84
sites
7703 Floyd Curl Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
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240 Medical Park Boulevard
Bristol, Tennessee 37620
Bristol, Tennessee 37620
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450 Clarkson Avenue
Brooklyn, New York 11203
Brooklyn, New York 11203
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175 South Union Boulevard
Colorado Springs, Colorado 80910
Colorado Springs, Colorado 80910
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6122 West Corporate Oaks Drive
Crystal River, Florida 34429
Crystal River, Florida 34429
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500 University Drive
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
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4085 University Boulevard South
Jacksonville, Florida 32216
Jacksonville, Florida 32216
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4720 South I-10 Service Road West
Metairie, Louisiana 70001
Metairie, Louisiana 70001
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8955 Southwest 87th Court
Miami, Florida 33176
Miami, Florida 33176
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286 Westward Drive
Miami Springs, Florida 33166
Miami Springs, Florida 33166
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2425 West 22nd Street
Oak Brook, Illinois 60523
Oak Brook, Illinois 60523
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11025 North Torrey Pines Road
San Diego, California 92130
San Diego, California 92130
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3216 Northeast 45th Place
Seattle, Washington 98105
Seattle, Washington 98105
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145 Applecross Road
Southern Pines, North Carolina 28388
Southern Pines, North Carolina 28388
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1111 West 17th Street
Tulsa, Oklahoma 74127
Tulsa, Oklahoma 74127
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