(HealthDay News) — For patients with uterine fibroids, once-daily relugolix combination therapy results in significantly reduced menstrual bleeding compared with placebo, according to a study published in the Feb. 18 issue of the New England Journal of Medicine.
Ayman Al-Hendy, MD, PhD, from the University of Chicago, and colleagues conducted 2 replicate international, double-blind, 24-week, phase 3 trials involving women with fibroid-associated heavy menstrual bleeding (388 women in trial L1 and 382 in trial L2). Participants were randomly assigned to receive once-daily placebo, relugolix combination therapy (relugolix, estradiol, and norethindrone acetate), or delayed relugolix combination therapy (relugolix monotherapy followed by relugolix combination therapy each for 12 weeks). The primary efficacy end point was the percentage of participants with response (volume of menstrual blood loss <80mL; ≥50 percent reduction in volume from baseline).
The researchers found that 73% and 71% of women in the relugolix combination therapy group in L1 and L2, respectively, had a response, compared with 19% and 15%, respectively, in the placebo group. In 6 of 7 key secondary end points, including measures of menstrual blood loss and pain, but not fibroid volume, significant improvements were seen in both relugolix combination groups compared with the placebo group. A similar incidence of adverse events was seen with relugolix combination therapy and placebo.
“This combination therapy is especially a great option for this younger population who want to preserve their fertility,” Al-Hendy said in a statement.
The study was funded by Myovant Sciences, the manufacturer of relugolix.