A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
NCT01620528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 872
Last updated 2018-09-18
Summary
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.
Conditions
- Endometriosis
Interventions
- DRUG
-
elagolix
oral tablet
- OTHER
-
placebo
oral tablet
Sponsors & Collaborators
-
AbbVie (prior sponsor, Abbott)
lead INDUSTRY
Principal Investigators
-
Rachel Duan, MD · AbbVie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-22
- Primary Completion
- 2014-11-14
- Completion
- 2015-09-28
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