Phase 3 Study of Relugolix Tablets for Treating Heavy Menstrual Bleeding Caused by Uterine Fibroids in Women

What this Trial Is About

Researchers are evaluating relugolix combined with megestrol acetate and medroxyprogesterone acetate for women experiencing heavy menstrual bleeding linked to uterine fibroids. This phase 3 trial aims to assess the benefits and safety of taking relugolix 40 mg daily compared to a placebo. About 120 women will participate, helping to answer how well this treatment reduces menstrual bleeding and its safety profile. Participants will be randomly assigned in a 21 ratio to receive either daily oral relugolix 40 mg together with megestrol acetate 1 mg and medroxyprogesterone acetate 2 mg for 12 weeks or placebo tablets matching these drugs for 12 weeks. After this double-blind period, all participants will receive the active treatment combination for another 12 weeks. The study includes a screening period lasting up to approximately 13 weeks and a 4-week follow-up period. Throughout the study, women will undergo safety checks including monitoring for adverse events, vital signs, physical exams, lab tests, bone density assessments, and heart function tests. Researchers will measure how many participants achieve a significant reduction in menstrual blood loss by the end of the double-blind period. Participants will be involved in clinic visits and assessments across the study duration, which includes screening, treatment, and follow-up phases.

Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids