Elagolix safe, effective for heavy menstrual bleeding
Elagolix is safe and effective for reducing heavy menstrual bleeding in females with fibroids, a new dose-ranging, multiple-cohort study has shown.
Investigators randomized 271 females (mean age 41.8 years) to receive elagolix alone (n=160), elagolix and an add-back therapy (n=61) or placebo (n=50). The primary study outcome was the mean and percentage change in menstrual blood loss (MBL).
Females who received elagolix had significantly larger reductions in MBL from baseline to last complete treatment cycle compared with those who received placebo (p<0.01). Inclusions of add-back on therapies also reduced the MBL compared with placebo, but in magnitudes lower than those in patients who took elagolix only.
Elagolix also exerted a dose-dependent suppressive effect on heavy menstrual bleeding, with those receiving the 300 mg twice-daily doses experiencing the most suppression. Indeed, even if the total daily dose was the same, twice-daily dosing resulted in similar or greater MBL reductions.
Majority (84.4 to 96.8 percent) of females in the elagolix group had menstruation within 90 days of the last dose, resulting in a median range of time to return to menstruation of 25 to 30 days. In the placebo group, 93.3 to 100 percent of the females returned to menstruation within 90 days, and the median range of time was 11 to 19 days.
“These results provide a rationale for phase IIb and III clinical trials of longer duration to further evaluate the safety and efficacy of elagolix with add-back regimens,” said researchers.