drugset / Trial / NCT00797225

Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

NCT00797225

Phase 2 Completed 174 enrolled AbbVie
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-11-26
Primary completion
2010-02-24
Completion
2010-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Elagolix Small molecule 150 mg Oral
Subject Elagolix Small molecule 250 mg Oral
Subject Leuprorelin Acetate Depot Unknown 3.75 mg Intramuscular

Indications