Phase 3 Study to Test the Safety and Effectiveness of KLH-2109 for Treating Excessive Menstrual Bleeding in Women with Uterine Fibroids

What this Trial Is About

Researchers are evaluating the investigational drug KLH-2109 for treating excessive menstrual bleeding in patients with uterine fibroids, which are noncancerous tumors in the uterus. This study aims to find out whether KLH-2109 can reduce the amount of menstrual bleeding, lower heavy bleeding, and assess its safety compared to a common treatment. The trial is a multi-center, randomized, double-blind, active-controlled, parallel Phase 3 study. Participants will receive either KLH-2109 at a dose of 200 mg daily by mouth for 24 weeks plus a placebo injection once every 4 weeks, or a placebo pill daily plus an injection of Leurprorelin acetate 1.88 mg or 3.75 mg once every 4 weeks for 24 weeks. The study compares these two treatment regimens to determine which is more effective and safe for managing heavy menstrual bleeding related to uterine fibroids. During the study, participants will visit the clinic regularly for health check-ups and safety tests. They will keep track of their menstrual bleeding and any health changes throughout the trial. The main outcome measured is the proportion of subjects achieving a low menstrual bleeding score between weeks 6 and 12, with additional measurements at weeks 6, 12, 18, and 24. The total participation time spans the 24-week treatment period with ongoing monitoring.

to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia