Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

Summary

The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.

Timeline

Start

2011-09-08

Primary completion

2013-11

Completion

2014-05-17

Outcome

Met primary endpoint

registry analysis (superiority test); Cohort 4 Elagolix 400 mg QD vs Cohort 4 Placebo; p < 0.001; LS Mean Difference -205.9 (95% CI -295.77 to -116.01); ANCOVA NCT01441635 ↗

registry analysis (superiority test); Cohort 4 Elagolix 100 mg BID vs Cohort 4 Placebo; p < 0.001; LS Mean Difference -189.9 (95% CI -278.33 to -101.53); ANCOVA NCT01441635 ↗

Publications

• Background Archer DF, Stewart EA, Jain RI, Feldman RA, Lukes AS, North JD, Soliman AM, Gao J, Ng JW, Chwalisz K. Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study. Fertil Steril. 2017 Jul;108(1):152-160.e4. doi: 10.1016/j.fertnstert.2017.05.006. Epub 2017 Jun 1.
• Coyne KS, Soliman AM, Margolis MK, Thompson CL, Chwalisz K. Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire. Curr Med Res Opin. 2017 Feb;33(2):193-200. doi: 10.1080/03007995.2016.1248382. Epub 2016 Nov 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elagolix	Small molecule	100 mg	—
Subject	Elagolix	Small molecule	200 mg	—
Subject	Elagolix	Small molecule	300 mg	—
Subject	Elagolix	Small molecule	400 mg	—
Subject	Elagolix	Small molecule	600 mg	—
Background	Estradiol	Other / unclassified	0.1 mg	Oral
Background	Estradiol	Other / unclassified	0.5 mg	Oral
Background	Estradiol	Other / unclassified	1 mg	—
Background	Progesterone	Other / unclassified	200 mg	—

Indications