NCT02654054

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

A Phase 3 Study to Evaluate the 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Uterine Fibroids
• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DRUG	Elagolix	Film-coated tablets
DRUG	Placebo for Estradiol/Norethindrone Acetate	Placebo capsules
DRUG	Estradiol/Norethindrone Acetate	Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
DRUG	Placebo for Elagolix	Film-coated placebo tablets

Timeline

• Start date: 2015-12-22
• Primary completion: 2018-01-18
• Completion: 2018-12-12
• First posted: 2016-01-13
• Last updated: 2020-06-29
• Results posted: 2020-06-29

Locations

96 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study