A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

Phase 4 Completed 82 enrolled AbbVie

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The main objective of this study is to assess safety and efficacy of elagolix compared to placebo in reducing heavy menstrual bleeding (HMB) associated with uterine fibroids in premenopausal women. The primary hypothesis is that elagolix, compared to placebo, reduces HMB associated with uterine fibroids in premenopausal women.

Timeline

Start: 2019-04-12
Primary completion: 2021-03-31
Completion: 2021-04-28

Outcome

Met primary endpoint

paper With elagolix, 49.4% (95% CI 35.1-63.8%) of patients met the primary endpoint, compared with 23.3% (95% CI 7.2-39.5%) of patients who received placebo ( P =.035). PMID 37769311 ↗

registry analysis (superiority test); Placebo vs Elagolix 150 mg; p = 0.035 NCT03886220 ↗

Publications

Brown E, Kroll R, Li H, Ng J, Pinsky B, Rodriguez JW, Thomas J, Snabes MC. Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2023 Nov 1;142(5):1068-1076. doi: 10.1097/AOG.0000000000005380. Epub 2023 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elagolix	Small molecule	150 mg	Oral