NCT03886220

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

A Phase 4 Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Elagolix	Oral; Tablet
DRUG	Placebo	Oral; Tablet

Timeline

• Start date: 2019-04-12
• Primary completion: 2021-03-31
• Completion: 2021-04-28
• First posted: 2019-03-22
• Last updated: 2022-03-31
• Results posted: 2022-03-31

Locations

48 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study