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

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

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

Indications