A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Kissei

Status and phase: Active, not recruiting; Phase 3

Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)

Treatments: Drug: KLH-2109; Drug: Leuprorelin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05440383

KLH2301

Details and patient eligibility

About

Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia

Enrollment: 264 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Premenopausal Japanese woman diagnosed with uterine fibroids
• Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
• Larger than a certain standard
• No calcification
• Not receiving surgical treatment
• Patients with a normal menstrual cycle
• Patients diagnosed with menorrhagia

Exclusion criteria

• Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
• Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
• Patients with undiagnosed abnormal genital bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 2 patient groups

KLH-2109

Experimental group

Description:

Oral administration

Treatment:

Drug: KLH-2109

Leuprorelin

Active Comparator group

Description:

Subcutaneous administration

Treatment:

Drug: Leuprorelin