Overview

Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Status:
Active, not recruiting

Trial end date:
2024-07-19

Target enrollment:

Participant gender:

Summary

This is phase 3b study seeks to evaluate the safety of elagolix in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. This study is double-blinded in the first year and an open-label for the next three years.

Phase:

Phase 3

Details

Lead Sponsor:

AbbVie

Treatments:

Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Norethindrone
Norethindrone acetate
Polyestradiol phosphate