A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: KLH-2109 Oral administration |
Drug: KLH-2109
Oral administration
|
Active Comparator: Leuprorelin Subcutaneous administration |
Drug: Leuprorelin
Subcutaneous administration
|
Outcome Measures
Primary Outcome Measures
- 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]
PBAC (pictorial blood loss assessment chart) score
Secondary Outcome Measures
- Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration [Up to 24 weeks]
PBAC (pictorial blood loss assessment chart) score
- Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration [Up to 24 weeks]
PBAC (pictorial blood loss assessment chart) score
- Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration [Up to 24 weeks]
PBAC (pictorial blood loss assessment chart) score
- Change from baseline in blood hemoglobin [Up to 24 weeks]
Hemoglobin
- Change rate from baseline in myoma volume [Up to 24 weeks]
Myoma volume
- Change rate from baseline in uterine volume [Up to 24 weeks]
Uterine volume
- Change from baseline in UFS-QOL score [Up to 24 weeks]
UFS-QOL (uterine fibroid symptom and QOL) score
- Incidence of adverse events and adverse drug reactions [Up to 24 weeks]
Adverse events and adverse drug reactions
- Change rate from baseline in bone metabolic markers (BAP and serum NTx) [Up to 24 weeks]
Bone metabolic markers (BAP and serum NTx)
- Change rate from baseline in bone density (DXA) [Up to 24 weeks]
Bone density, T-score
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kissei Pharmaceutical Co., Ltd.
Investigators
- Study Director: Yoshitaka Shimizu, Kissei Pharmaceutical Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KLH2301