Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

NCT02654054 PHASE3 COMPLETED Results posted

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Details

Lead sponsor	AbbVie
Phase	PHASE3
Status	COMPLETED
Enrolment	413
Start date	Tue Dec 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Dec 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Uterine Fibroids
• Heavy Menstrual Bleeding

Interventions

• Elagolix
• Placebo for Estradiol/Norethindrone Acetate
• Estradiol/Norethindrone Acetate
• Placebo for Elagolix

Countries

Canada, United States, Puerto Rico