A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01620528
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • elagolix — DRUG
    oral tablet
  • placebo — OTHER
    oral tablet

Study Details

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.

Key Dates

Start date
May 22, 2012
Status verified
Mar 2017
Primary completion
Nov 14, 2014
Completion
Sep 28, 2015

Study Design

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

Arms

  • Experimental: Elagolix 150 mg QD
    Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
  • Experimental: Elagolix 200 mg BID
    Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period
  • Placebo Comparator: Placebo
    Placebo BID for the 6-month Treatment Period

Primary Outcome Measure

Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) [ Time Frame: At Month 3 of the Treatment Period ]

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