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

• Status: Not yet recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.
• Treatments: Leuprolide

Criteria

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:

• Maximum diameter ≥3 cm

• No calcification

• Not receiving surgical treatment

• Patients diagnosed with menorrhagia with a total PBAC score ≥120 for one menstrual cycle immediately before the start of the treatment period

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