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

A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain

Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain

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
• Patients with pain symptoms associated with uterine fibroids

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