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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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
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