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

JW Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Uterine Fibroids; Menorrhagia

Treatments: Drug: KLH-2109+ Leurprorelin acetate Placebo; Drug: KLH-2109 Placebo + Leurprorelin acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT07378098

JW25301

Details and patient eligibility

About

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

Full description

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

Enrollment: 254 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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254 participants in 2 patient groups

KLH-2109+ Leurprorelin acetate Placebo

Experimental group

Description:

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

Treatment:

Drug: KLH-2109+ Leurprorelin acetate Placebo

KLH-2109 Placebo + Leurprorelin acetate

Active Comparator group

Description:

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

Treatment:

Drug: KLH-2109 Placebo + Leurprorelin acetate