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

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

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

Conditions
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Uterine Fibroids (MeSH Heading: Leiomyoma)

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


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 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

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> | Drug: KLH-2109<br>* Oral administration<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral 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 | 
| Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration | NRS (numeric rating scale) for pain | 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 12 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 12 weeks | 
| Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days | NRS (numerical rating scale) | Up to 12 weeks | 
| Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration | NRS (numerical rating scale) | Up to 12 weeks | 
| Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days | NRS (numerical rating scale) | Up to 12 weeks | 
| Average NRS score every 28 days for pain symptoms | NRS (numerical rating scale) | Up to 12 weeks | 
| Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) during 28 days before end of study drug administration | NRS (numerical rating scale) | Up to 12 weeks | 
| Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days | NRS (numerical rating scale) | Up to 12 weeks | 
| Incidence of adverse events and adverse drug reactions | Adverse events and adverse drug reactions | Up to 12 weeks |