Efficacy and Safety Study of Elagolix in Women With Endometriosis
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.
Timeline
- Start
- 2009-10-12
- Primary completion
- 2010-09-22
- Completion
- 2010-09-22
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Elagolix 150 mg; p = 0.0262; LS Mean Difference -0.24 (95% CI -0.45 to -0.03); ANCOVA NCT00973973 ↗
registry analysis (superiority test); Placebo vs Elagolix 150 mg; p = 0.0163; LS Mean Difference -0.21 (95% CI -0.38 to -0.04); ANCOVA NCT00973973 ↗
registry analysis (superiority test); Placebo vs Elagolix 150 mg; p = 0.0089; LS Mean Difference -0.22 (95% CI -0.38 to -0.06); ANCOVA NCT00973973 ↗
registry analysis (superiority test); Placebo vs Elagolix 150 mg; p = 0.0360; LS Mean Difference -0.27 (95% CI -0.52 to -0.02); ANCOVA NCT00973973 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elagolix | Small molecule | 150 mg | Oral |