Endometriosis, Pain Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 Sodium in Subjects With Endometriosis
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00619866 -
An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
|
Phase 2 |