Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

Sponsor
AbbVie
Study ID
NCT02143713
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 adult pre-menopausal women who completed 6 months treatment in pivotal Study M12-671 (NCT01931670).

Key Dates

Start date
May 27, 2014
Status verified
Jul 2021
Primary completion
Jun 22, 2016
Completion
May 23, 2017

Study Design

Enrollment
496 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 M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6 ]

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