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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07378098

Enrollment

254

Registered

2026-01-30

Start date

2026-02-03

Completion date

2028-09-03

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia, Uterine Fibroids

Keywords

Uterine Fibroids, Menorrhagia

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

Detailed description

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

Interventions

DRUGKLH-2109+ Leurprorelin acetate Placebo

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

DRUGKLH-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

randomized, double-blind, active-controlled, parallel, phase III

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* Individuals diagnosed with uterine fibroids

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of subjects with a total PBAC score < 10	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

Measure	Time frame	Description
Proportion of subjects with a total PBAC score < 10	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

Countries

South Korea

Contacts

CONTACTDeageun Song

daegeun.song@jwhealthcare.com82-2-840-6792

PRINCIPAL_INVESTIGATORJeong Yeol Park

Asan Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026