Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

Sponsor
AbbVie
Study ID
NCT01760954
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Elagolix — DRUG
    Elagolix tablets administered orally

Study Details

A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.

Key Dates

Start date
Dec 28, 2012
Status verified
Jul 2021
Primary completion
May 31, 2015
Completion
Apr 15, 2016

Study Design

Enrollment
506 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Elagolix 150 mg QD
    Participants received elagolix 150 mg tablets once a day (QD) for 6 months.
  • Experimental: Elagolix 200 mg BID
    Participants received elagolix 200 mg tablets twice a day (BID) for 6 months.

Primary Outcome Measure

Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment [ Time Frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6 ]

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