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

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

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

Conditions
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Uterine Fibroids (MeSH Heading: Leiomyoma)

Intervention / Treatment
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* Drug: KLH-2109
* Drug: Leuprorelin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KLH-2109<br>Oral administration | Drug: KLH-2109<br>* Oral administration<br>|
| Active Comparator: Leuprorelin<br>Subcutaneous administration | Drug: Leuprorelin<br>* Subcutaneous administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration | PBAC (pictorial blood loss assessment chart) score | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration | PBAC (pictorial blood loss assessment chart) score | Up to 24 weeks | 
| Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration | PBAC (pictorial blood loss assessment chart) score | Up to 24 weeks | 
| Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration | PBAC (pictorial blood loss assessment chart) score | Up to 24 weeks | 
| Change from baseline in blood hemoglobin | Hemoglobin | Up to 24 weeks | 
| Change rate from baseline in myoma volume | Myoma volume | Up to 24 weeks | 
| Change rate from baseline in uterine volume | Uterine volume | Up to 24 weeks | 
| Change from baseline in UFS-QOL score | UFS-QOL (uterine fibroid symptom and QOL) score | Up to 24 weeks | 
| Incidence of adverse events and adverse drug reactions | Adverse events and adverse drug reactions | Up to 24 weeks | 
| Change rate from baseline in bone metabolic markers (BAP and serum NTx) | Bone metabolic markers (BAP and serum NTx) | Up to 24 weeks | 
| Change rate from baseline in bone density (DXA) | Bone density, T-score | Up to 24 weeks |