NCT07378098

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

A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3 Study to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: JW Pharmaceutical · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3

Conditions

• Menorrhagia
• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	KLH-2109+ Leurprorelin acetate Placebo	KLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection
DRUG	KLH-2109 Placebo + Leurprorelin acetate	KLH-2109 Placebo: for 24 weeks(PO, QD) Leurprorelin acetate Placebo: 1.88mg or 3.75mg , Once every 4 weeks, subcutaneous injection

Timeline

• Start date: 2026-01-26
• Primary completion: 2028-03-31
• Completion: 2028-09-03
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: South Korea