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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Menorrhagia, Uterine Fibroids

In brief

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

Key facts

Study ID

NCT07378098

Run by

JW Pharmaceutical

People needed

254

Starts

2026-02-03

Expected to finish

2028-09-03

Last updated by the study team

2026-05-01

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Individuals diagnosed with uterine fibroids

You may not qualify if…

• Metrorrhagia or anovulatory bleeding
• Patients with a history of total hysterectomy or bilateral oophorectomy

Where it is running

• Asan Medical Center — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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