A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Sponsor
AbbVie
Study ID
NCT01931670
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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 subjects.

Key Dates

Start date
Sep 9, 2013
Status verified
Mar 2018
Primary completion
Jan 6, 2016
Completion
Dec 19, 2016

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo twice daily (BID) for the 6-month Treatment Period
  • 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 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 ]

Related Studies