Relugolix combo significantly reduces menstrual bleeding in uterine fibroids patients: NEJM

USA: Once-daily treatment with relugolix combination therapy (relugolix, estradiol and norethindrone acetate) significantly reduces menstrual bleeding and preserves BMD in women with uterine fibroids, finds a recent study the in the New England Journal of Medicine.

Uterine fibroids, non-cancerous growths in the uterus, are a common cause of heavy menstrual bleeding and pain. Once daily administration of combination therapy of relugolix -- an oral gonadotropin-releasing hormone-receptor antagonist -- may be effective in women with uterine fibroids and heavy bleeding while avoiding hypoestrogenic effects.

Ayman Al-Hendy, a professor of obstetrics and gynecology at the University of Chicago Medicine, and colleagues conducted two replicate international, double-blind, 24-week, phase 3 trials that involved women with fibroid-associated heavy menstrual bleeding. The participants were randomly assigned in the ratio of 1:1:1 to receive  once-daily placebo, relugolix combination therapy (40 mg of relugolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate), or delayed relugolix combination therapy (40 mg of relugolix monotherapy, followed by relugolix combination therapy, each for 12 weeks).