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Clinical trial

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

ID
Name
KLH2301
Description
Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia
Trial arms
Trial start
2022-10-11
Estimated PCD
2025-05-01
Trial end
2025-05-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
KLH-2109
Oral administration
Arms:
KLH-2109
Leuprorelin
Subcutaneous administration
Arms:
Leuprorelin
Size
264
Primary endpoint
Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
Up to 12 weeks
Eligibility 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: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 264, 'type': 'ESTIMATED'}}
Updated at
2023-09-21

1 organization

2 products

1 indication

Organization
Kissei Pharmaceutical
Product
Leuprorelin
Indication
Uterine Fibroids
Product
KLH-2109