drugset / Trial / NCT03213457

A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

NCT03213457

Phase 3 Completed 681 enrolled AbbVie
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

Timeline

Start
2017-07-07
Primary completion
2020-03-27
Completion
2023-12-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Elagolix Small molecule 200 mg
Subject Estradiol/Norethindrone Acetate Unknown 0.5 mg
Subject Estradiol/Norethindrone Acetate Unknown 1 mg

Indications