The study met its primary endpoint with relugolix demonstrating a marked decrease in menstrual blood loss from Week 6 to Week 12 as assessed by a patient-reported outcome (p < 0.0003 at relugolix 40-mg dose vs. placebo). The findings were presented during a poster session (Abstract #17H) on May 7 at the 2017 Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists, which is being held in San Diego, California, May 6-9, 2017.
Relugolix demonstrated statistical significance over placebo in the primary endpoint of the proportion of subjects who had reduction in menstrual blood loss from a score of at least 120 required at study entry to less than 10 from Week 6 through Week 12 on the Pictorial Blood Loss Assessment Chart (PBAC). Relugolix decreased menstrual blood loss in a dose-dependent manner with the highest proportion of responses [84%, 95% confidence interval (74% to 93%) vs. placebo] in the relugolix 40-mg group.
In the relugolix 40-mg group, 73% of women achieved amenorrhea (i.e. a PBAC score of 0, representing no menstrual blood loss) from Week 6 through Week 12. No women in the placebo group achieved amenorrhea. At Week 12, the 40-mg group demonstrated an absolute reduction in myoma and uterine volumes of approximately 50% from baseline compared to placebo.
By Week 12, there was an increase in hemoglobin levels in the relugolix 20- and 40-mg groups compared to placebo. Patient-reported pain from uterine fibroids, based upon the numerical rating scale (NRS) score, indicated that patients who received relugolix treatment had fewer pain symptoms from Week 6 to Week 12, with the relugolix 40-mg dose having the greatest reported reduction of pain symptoms.
The most commonly observed adverse events (occurring more than 10% more frequently in treatment groups vs. placebo) were mild or moderate in severity and included headache, metrorrhagia, menorrhagia, and hot flush. Bone mineral density decreased in a dose-dependent fashion with the greatest loss (-2.3%) observed in the relugolix 40-mg group.
"These data provide a strong basis for our ongoing phase 3 studies, LIBERTY 1 & 2, which are evaluating relugolix co-administered with low-dose hormonal add-back therapy in women with uterine fibroids and heavy menstrual bleeding," said Lynn Seely, MD, President & Chief Executive Officer of Myovant Sciences.
"Myovant hopes to provide women with a well-tolerated medical therapy to treat symptoms of uterine fibroids as an alternative to hysterectomy and other invasive procedures commonly performed to treat this condition."