MedTrace Logo

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

NCT07378098 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2026-05-01

No results posted yet for this 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

Conditions

  • Menorrhagia
  • Uterine Fibroids

Interventions

DRUG

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 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

Sponsors & Collaborators

Principal Investigators

  • Jeong Yeol Park · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-03
Primary Completion
2028-03-31
Completion
2028-09-03

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07378098 on ClinicalTrials.gov