Status:
COMPLETED
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Lead Sponsor:
Kissei Pharmaceutical Co., Ltd.
Conditions:
Uterine Fibroids (MeSH Heading: Leiomyoma)
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2024
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT05440383
Start Date
October 11 2022
End Date
August 21 2024
Last Update
March 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Resarch Site
Multiple Locations, Japan