Treatment of Uterine Fibroid Symptoms with Relugolix Combination Therapy
Two identical 24-week, phase 3 trials (n=388 & 382) found once-daily relugolix, an oral gonadotropin-releasing hormone-receptor antagonist, in combination with estradiol & norethindrone acetate, resulted in significant reduction in menstrual bleeding vs placebo, & preserved BMD.
Source:
New England Journal of Medicine
SPS commentary:
In the study, participants were randomised to receive once-daily placebo, relugolix combination therapy (40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate), or delayed relugolix combination therapy (40 mg relugolix monotherapy, followed by relugolix combination therapy, each for 12 weeks). Overall, 73% in the relugolix combination therapy group in trial L1 and 71% of those in trial L2 had a response (primary end point), as compared with 19% and 15%, respectively, of those in the placebo groups (p<0.001 for both comparisons).