NCT07378098

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P50-P75 for phase_3

Timeline
28mo left

Started Feb 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Feb 2026Sep 2028

First Submitted

Initial submission to the registry

January 19, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2028

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

January 19, 2026

Last Update Submit

April 27, 2026

Conditions

MenorrhagiaUterine Fibroids

Keywords

Uterine FibroidsMenorrhagia

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with a total PBAC score < 10

    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 Outcomes (1)

  • Proportion of subjects with a total PBAC score < 10

    Week 6 , Week12, Week 18, Week 24

Study Arms (2)

KLH-2109+ Leurprorelin acetate Placebo

EXPERIMENTAL

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 Placebo + Leurprorelin acetate

ACTIVE COMPARATOR

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

Interventions

KLH-2109 Placebo + Leurprorelin acetateDRUG

KLH-2109 Placebo: for 24 weeks(PO, QD) Leurprorelin acetate Placebo: 1.88mg or 3.75mg , Once every 4 weeks, subcutaneous injection

Also known as: KLH-2019 Placebo + Leurprorelin acetate Placebo
KLH-2109 Placebo + Leurprorelin acetate
KLH-2109+ Leurprorelin acetate PlaceboDRUG

KLH-2109 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection

Also known as: KLH-2019+ Leurprorelin acetate Placebo
KLH-2109+ Leurprorelin acetate Placebo

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsUterine fibroid patients with menorrhagia
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

MenorrhagiaLeiomyoma

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsMenstruation DisturbancesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Jeong Yeol Park

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deageun Song

CONTACT

82-2-840-6792daegeun.song@jwhealthcare.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, double-blind, active-controlled, parallel, phase III
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2026

First Posted

January 30, 2026

Study Start

February 3, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

September 3, 2028

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)