drugset / Trial / NCT03343067

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

NCT03343067

Phase 3 Terminated 11 enrolled AbbVie
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.

Timeline

Start
2017-12-27
Primary completion
2018-10-23
Completion
2018-10-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Elagolix Small molecule 150 mg
Subject Elagolix Small molecule 200 mg
Subject Estradiol Other / unclassified 1 mg
Subject Norethindrone Unknown 0.5 mg

Indications