A Phase 3b Study to Evaluate the Long-Term 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 3b Study to Evaluate the Long-Term Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
This randomized multicenter 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 was double-blind (DB) during the first 12 months and open-label (OL) for the next 36 months.
478 participants were randomly assigned at a ratio of 2:1 to the following treatment groups:
This study was double-blinded during the first 12 months and open-label for the next 36 months. Participants entered up to 12 months of PTFU after completing treatment Month 48 (or at any time a participant prematurely discontinued treatment).
Inclusion Criteria:
Exclusion Criteria:
Huntington Beach, California 92647, United States
Washington D.C., District of Columbia 20011, United States
Brandon, Florida 33510-3107, United States
St. Petersburg, Florida 33709-3113, United States
Suwanee, Georgia 30024-7159, United States
Chicago, Illinois 60605-2168, United States
Neptune City, New Jersey 07753-4859, United States
Manhasset, New York 11030-3816, United States
Durham, North Carolina 27713-7512, United States
Raleigh, North Carolina 27612, United States
Hershey, Pennsylvania 17033, United States
Austin, Texas 78758-5653, United States
Dallas, Texas 75390-8575, United States