NCT00619866

An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.

Detailed description

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 months. Participants will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (QD); 250 mg elagolix QD or placebo QD. Following 12 weeks of dosing, participants will continue in the study for an additional 12 weeks; participants randomized to elagolix will continue to receive their assigned dose and participants randomized to placebo will be re-randomized to receive one of the two doses of elagolix for 12 weeks in a double-blind fashion. Six weeks after the last dose of study drug at the end of Week 24, a follow-up visit will be performed (end of Week 30).

Conditions

• Endometriosis, Pain

Interventions

Type	Name	Description
DRUG	Elagolix	Elagolix tablets administered orally
DRUG	placebo	Placebo tablet administered orally

Timeline

• Start date: 2008-02-19
• Primary completion: 2009-04-20
• Completion: 2009-08-28
• First posted: 2008-02-21
• Last updated: 2018-09-07
• Results posted: 2018-09-07

Regulatory

• FDA-regulated drug study