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NCT Number: NCT07378098

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

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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Menstruation Disturbances Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Fibroids Uterine Hemorrhage

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Location status: Recruiting

Location contact

Jeong Yeol Park

CONTACT

02-3010-3629

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals diagnosed with uterine fibroids

Exclusion criteria

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

Treatment and study plan

KLH-2109+ Leurprorelin acetate Placebo

Drug

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

KLH-2109 Placebo + Leurprorelin acetate

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Deageun Song

CONTACT

[email protected]

82-2-840-6792

Sponsors and collaborators

Lead sponsor

JW Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 30, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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