Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

Sponsor
AbbVie
Study ID
NCT00797225
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Leuprorelin Acetate Depot — DRUG
    Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection
  • Elagolix — DRUG
    Elagolix tablets administered orally
  • Placebo to Elagolix — DRUG
    Placebo tablet administered orally
  • Placebo to Leuprorelin Acetate — DRUG
    Saline solution administered as an intramuscular injection

Study Details

This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.

Key Dates

Start date
Nov 26, 2008
Status verified
Apr 2018
Primary completion
Feb 24, 2010
Completion
Feb 24, 2010

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.
  • Experimental: Elagolix 150 mg
    Participants received elagolix 150 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg for an additional 12 weeks.
  • Experimental: Elagolix 250 mg
    Participants received elagolix 250 mg tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
  • Other: Leuprorelin
    Participants received placebo tablets once a day and leuprorelin acetate 1-month depot 3.75 mg intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks.

Primary Outcome Measure

Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain [ Time Frame: Baseline and Weeks 4, 8, and 12 ]

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