At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 174 enrolled
Drug / intervention
Leuprorelin Acetate Depot +3 moredrug
Likely dose
Leuprorelin Acetate Depot 3.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis
In Brief
A Phase 2 clinical trial evaluating Leuprorelin Acetate Depot, Elagolix, and 2 other interventions for Endometriosis. Completed, enrolled 174 participants.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometriosis
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartNov 2008
Primary CompletionFeb 2010
TodayJul 2026
First PostedNov 25, 2008
Enrollment StartNov 26, 2008
Primary CompletionFeb 24, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.6 years ago
Interventions
Leuprorelin Acetate Depotdrug
Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection
Elagolixdrug
Elagolix tablets administered orally
Placebo to Elagolixdrug
Placebo tablet administered orally
Placebo to Leuprorelin Acetatedrug
Saline solution administered as an intramuscular injection