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

April 27, 2026 updated by: JW Pharmaceutical

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

254

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Jeong Yeol Park
          • Phone Number: 02-3010-3629

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals diagnosed with uterine fibroids

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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+ Leurprorelin acetate Placebo
KLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection
Other Names:
  • KLH-2019+ Leurprorelin acetate Placebo
Active Comparator: KLH-2109 Placebo + Leurprorelin acetate
KLH-2109 Placebo: 24 weeks(PO, QD) Leurprorelin acetate : 1.88mg or 3.75mg, 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
Other Names:
  • KLH-2019 Placebo + Leurprorelin acetate Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with a total PBAC score < 10
Time Frame: Week 6 to the day before Week 12
Proportion of subjects with a total PBAC score < 10 from Week 6 to the day before Week 12 after administration of the investigational product
Week 6 to the day before Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with a total PBAC score < 10
Time Frame: Week 6 , Week12, Week 18, Week 24
Proportion of subjects with a total PBAC score < 10 from Week 2 to the day before Week 6 after administration of the investigational product
Week 6 , Week12, Week 18, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JW Pharmaceutical

Investigators

  • Principal Investigator: Jeong Yeol Park, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

September 3, 2028

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JW25301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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