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

Phase 2 Completed 571 enrolled AbbVie

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2013-04-08
Primary completion: 2015-06
Completion: 2015-12

Publications

Carr BR, Stewart EA, Archer DF, Al-Hendy A, Bradley L, Watts NB, Diamond MP, Gao J, Owens CD, Chwalisz K, Duan WR, Soliman AM, Dufek MB, Simon JA. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1252-1264. doi: 10.1097/AOG.0000000000002933.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elagolix	Small molecule	300 mg	Oral
Subject	Elagolix	Small molecule	600 mg	Oral
Subject	Estradiol	Other / unclassified	0.5 mg	Oral
Subject	Estradiol	Other / unclassified	1 mg	Oral
Subject	Norethindrone	Unknown	0.1 mg	Oral
Subject	Norethindrone	Unknown	0.5 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications