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

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

Outcome

Met primary endpoint

registry analysis (superiority test); Cohort 1: Placebo vs Cohort 1: Elagolix 300 mg BID; p < 0.001; Odds Ratio (OR) 32.51 (95% CI 11.12 to 95.05); NCT01817530 ↗

paper and 27% (32%) for placebo (all P<.001 vs placebo). PMID 30303923 ↗

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

Indications