NCT00973973

Efficacy and Safety Study of Elagolix in Women With Endometriosis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 Sodium in Subjects With Endometriosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.

Detailed description

Participants were randomized (1:1) to 150 mg elagolix once daily or placebo once daily for the first 8 weeks of the study. Following 8 weeks of dosing, participants continued in the study for an additional 16 weeks in an open-label phase where all participants still enrolled in the study received 150 mg elagolix once daily. There was no pre-specified primary efficacy end point for this study as there is no single key efficacy outcome measure in this exploratory Phase 2 study. However, the efficacy measures of primary interest included the daily assessment of dysmenorrhea, non-menstrual pelvic pain and dyspareunia on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

Conditions

• Endometriosis, Pain

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo tablets taken orally once a day
DRUG	Elagolix	Immediate release (IR) tablets taken orally once a day

Timeline

• Start date: 2009-10-12
• Primary completion: 2010-09-22
• Completion: 2010-09-22
• First posted: 2009-09-09
• Last updated: 2018-09-26
• Results posted: 2018-09-26

Regulatory

• FDA-regulated drug study