Nearly three-quarters of women with uterine fibroids who used the once-daily oral gonadotropin-releasing hormone receptor antagonist relugolix experienced a decrease in menstrual blood volume loss of at least 50%, according to a press release from Myovant Sciences.
The company announced results of the LIBERTY 1 trial, the first of two phase 3 trials for the medication. The study included 388 women who lost 80 mL of blood or more during two consecutive menstrual cycles or 160 mL during a single cycle. During the 24-week trial, each day participants took either 40 mg relugolix combined with 1 mg estradiol and 0.5 mg norethindrone acetate, 40 mg relugolix alone for 12 weeks and followed by the combination for 12 weeks, or placebo.
Of the women who received the combination therapy, 73.4% had their menstrual blood volume loss decreased by at least 50% while experiencing a menstrual blood volume loss of less than 80 mL. This compared with 18.9% of the women in the placebo group who met these endpoints (P < .0001). According to the release, the average reduction in menstrual blood loss was 84.3% compared with baseline for women who had daily relugolix combination therapy.
Adverse events were reported by 62% of those who took relugolix and 66% of those in the placebo group, with the most common being hot flush, according to the release.
Myovant Sciences is currently conducting a second phase 3 trial and should those results provide further evidence of efficacy, the company will move forward with an application with the FDA, according to the company. Results from the second phase 3 trial are expected to be available later this year.
“We are incredibly pleased with the positive results of this first phase 3 study demonstrating a clinically meaningful response in a high proportion of women while maintaining bone health,” Lynn Seely, MD, president and CEO of Myovant Sciences, said in the release. “These results substantiate our once-daily oral combination therapy approach. The improvements in symptoms most relevant to women, such as reduction in menstrual blood loss and pain, and improvement in quality of life are particularly exciting. We look forward to the possibility of bringing a new treatment option, suitable for long-term use, to the millions of women suffering from this debilitating disease.”
Disclosure: Lynn Seely, MD, reports she is president and CEO of Myovant Sciences.