NCT01817530

Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)

A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 571 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.

Conditions

• Heavy Uterine Bleeding
• Uterine Fibroids

Interventions

Type	Name	Description
OTHER	Elagolix placebo	oral coated tablet
DRUG	Elagolix	oral coated tablet
DRUG	0.5 mg estradiol / 0.1 mg norethindrone acetate	oral hard capsule
DRUG	1 mg estradiol / 0.5 mg norethindrone acetate	oral hard capsule
DRUG	E2/NETA placebo	oral hard capsule

Timeline

• Start date: 2013-04-08
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2013-03-25
• Last updated: 2020-07-21
• Results posted: 2020-07-21