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 |
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.
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
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