The goal of this clinical trial was to determine whether the investigational drug KLH-2109 is effective for treating excessive menstrual bleeding in patients with uterine fibroids. Uterine fibroids are benign tumors that grown in the uterus. The primary objectives of this trial were to answer the following questions: * Does KLH-2109 lower the amount of menstrual bleeding? * Does KLH-2109 reduce menstrual bleeding? * Is KLH-2109 safe for participants to use? Investigators will compare KLH-2109 with a standard of care treatment (control) to determine which treatment is more effective. Participants will be required to follow: * Take either KLH-2109 or the common treatment as a pill * Visit the clinic regularly for health checkups and safety tests * Keep track of their bleeding and any health changes during the study
A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
254
KLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection
KLH-2109 Placebo: for 24 weeks(PO, QD) Leurprorelin acetate Placebo: 1.88mg or 3.75mg , Once every 4 weeks, subcutaneous injection
Asan Medical Center
Seoul, South Korea
RECRUITINGProportion of subjects with a total PBAC score < 10
Proportion of subjects with a total PBAC score \< 10 from Week 6 to the day before Week 12 after administration of the investigational product
Time frame: Week 6 to the day before Week 12
Proportion of subjects with a total PBAC score < 10
Proportion of subjects with a total PBAC score \< 10 from Week 2 to the day before Week 6 after administration of the investigational product
Time frame: Week 6 , Week12, Week 18, Week 24
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