Treatment of uterine fibroid symptoms with relugolix combination therapy

A pair of replicate studies assessed whether relugolix, an oral gonadotropin-releasing hormone-receptor antagonist, relieves symptoms associated with uterine fibroids. All 770 females participating in the Phase III trials suffered heavy menstrual bleeding as a result of fibroids. For each investigation, they were randomly designated to one of two relugolix treatment arms or to a control cohort. Members of the intervention groups received either relugolix plus estradiol and norethindrone acetate daily for a period of 24 weeks or delayed combination therapy, which consisted of relugolix monotherapy for 12 weeks followed by relugolix combination therapy for an additional 12 weeks. For the first trial, 73% of enrollees who received relugolix combination therapy achieved treatment response—defined as volume of menstrual blood loss of less than 80 ml and a 50% or greater reduction from baseline. A total of 71% of the women in this arm met the outcome in the second study. By comparison, the share among placebo recipients was 19% and 15% in the first and second trials, respectively. Compared with placebo, women who received either relugolix intervention also registered significant improvement in terms of pain, distress from bleeding and pelvic discomfort, anemia, and uterine volume. In addition to these benefits, researchers determined that once-daily relugolix combination therapy preserved bone mineral density in women with uterine fibroids.