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

Last updated: January 28, 2026
Sponsor: JW Pharmaceutical
Overall Status: Active - Recruiting

Phase

3

Condition

Dysfunctional Uterine Bleeding

Heavy Bleeding / Heavy Periods

Menstrual Disorders

Treatment

KLH-2109+ Leurprorelin acetate Placebo

KLH-2109 Placebo + Leurprorelin acetate

Clinical Study ID

NCT07378098
JW25301
  • Ages > 19
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Individuals diagnosed with uterine fibroids

Exclusion

Exclusion Criteria:

  • Metrorrhagia or anovulatory bleeding

  • Patients with a history of total hysterectomy or bilateral oophorectomy

Study Design

Total Participants: 254
Treatment Group(s): 2
Primary Treatment: KLH-2109+ Leurprorelin acetate Placebo
Phase: 3
Study Start date:
January 26, 2026
Estimated Completion Date:
September 03, 2028

Study Description

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

Connect with a study center

  • Asan Medical Center

    Seoul 1835848,
    South Korea

    Active - Recruiting

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