NCT01441635

Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: Female
• Age: 20 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.

Conditions

• Heavy Uterine Bleeding
• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Elagolix	Elagolix tablets
DRUG	Placebo	Matching placebo tablets
DRUG	Estradiol/Norethindrone acetate (E2/NETA)	A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.
DRUG	Estradiol	1.0 mg micronized estradiol tablets administered once a day
DRUG	Progesterone	Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle

Timeline

• Start date: 2011-09-08
• Primary completion: 2013-11-01
• Completion: 2014-05-17
• First posted: 2011-09-28
• Last updated: 2021-07-13
• Results posted: 2020-07-15

Regulatory

• FDA-regulated drug study