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.