Elagolix monotherapy Safe Against Heavy Menstrual Bleeding associated with Uterine Leiomyomas

A new phase 4 study published in The Journal of Obstetrics and Gynecology found elagolix 150 mg monotherapy taken once-daily to solve heavy menstrual bleeding associated with uterine leiomyomas were the safe and effective. This offers promise to premenopausal patients aged 18–51 years.

This randomized, double-blind, placebo-controlled study assessed  a total of 82 patients, with 54 receiving elagolix 150 mg and 28 receiving a placebo. The primary endpoint was a reduction in menstrual blood loss volume to less than 80 mL at the final month, coupled with at least a 50% reduction from baseline to the final month.

The results found 49.4% of patients in the elagolix group who met the primary endpoint, compared with 23.3% in the placebo group (P=.035). The differences in mean reduction of menstrual blood loss were significant as early as month 1 (P<.05 for months 1–3 and 5).

Moreover, elagolix demonstrated its effectiveness in suppressing bleeding (P=.036). The patients on elagolix experienced greater improvements in the proportion of those with amenorrhea, hemoglobin concentrations, and health-related quality of life.

Elagolix treatment was well-tolerated. There were no serious or severe adverse events reported, in stark contrast to the 7.1% of participants in the placebo group facing serious adverse events, including coronavirus disease 2019 (COVID-19) and an enlarged uvula. Only 5.6% of patients discontinued elagolix due to adverse events.

This study brings out a significant improvement in addressing heavy menstrual bleeding associated with uterine leiomyomas in premenopausal patients. The positive outcomes of elagolix 150 mg once-daily monotherapy, coupled with its favorable safety profile, underscore its potential as a transformative treatment option.

Source:

Brown, E., Kroll, R., Li, H., Ng, J., Pinsky, B., Rodriguez, J. W., Thomas, J., & Snabes, M. C. (2023). Low-dose elagolix for the treatment of heavy menstrual bleeding in patients with uterine leiomyomas: A randomized controlled trial. Obstetrics and Gynecology, 142(5), 1068–1076. https://doi.org/10.1097/aog.0000000000005380