Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

Study Overview
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Brief Summary
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This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase

Official Title
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A Randomized, Double-blind, Placebo-controlled, Six-month Parallel-group Study to Assess Efficacy and Safety of Dutasteride 0.5mg Once Daily in Chinese Patients With Benign Prostatic Hyperplasia (BPH), Followed by a 12-month Open-label Treatment Phase

Conditions
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Prostatic Hyperplasia, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Dutasteride 0.5mg capsule
* Drug: Dutasteride matched placebo


Participation Criteria
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Eligibility Criteria
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Inclusion: Clinical diagnosis of BPH AUA-SI >=12 [American Urological Association Symptom Index] Qmax > 5ml/sec and <=15ml/sec and minimum voided volume of >=125ml Prostate volume >=30cm(3) Exclusion: Post void residual volume >250ml History or evidence of prostate cancer Total serum PSA <1.5ng/ml or >10.0ng/ml (Prostate specific antigen) Previous prostatic surgery or other invasive procedures to treat BPH. History of AUR (Acute Urinary Retention) within 3 months History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate History of hepatic impairment or abnormal liver function tests Use of any 5a-reductase inhibitors ,any drugs with antiandrogenic properties or other drugs noted for gynaecomastia effects, or could affect prostate volume, within past 6 months and throughout the study Use of alpha-receptor blockers within 2 weeks and throughout the study. Use of phytotherapy for BPH within 2 weeks and/or predicted to need phytotherapy during the study. Concurrent use of anabolic steroids Use of any alpha-adrenergic agonists or cholinergics within 48 hours prior to uroflowmetry assessment. Hypersensitivity to any 5a-reductase inhibitor or other chemically-related drugs. Actively trying to procreate or unwilling to wear a condom during intercourse with a woman of childbearing potential for duration of participation in this study and 16 weeks following treatment. History or current evidence of drug or alcohol abuse within the previous 12 months. History of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient. Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, of cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management. History of renal insufficiency, or serum creatinine >1.5xULN (Upper Limit of Normal ) Participation in any investigational or marketed drug trial within 30 days and during the course of the study.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

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: A<br>dutasteride 0.5mg once daily orally | Drug: Dutasteride 0.5mg capsule<br>* Dutasteride 0.5mg once daily orally<br>|
| Placebo Comparator: B<br>Placebo matched once daily orally | Drug: Dutasteride matched placebo<br>* Dutasteride matched placebo once daily orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in the Prostate Volume at Month 6 | Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound. | Baseline and Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in the Prostate Volume at Month 3 | Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound. | Baseline and Month 3 | 
| Change From Baseline in the Prostate Volume at Month 6 | Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound. | Baseline and Month 6 | 
| Change From Baseline in the Prostate Volume at Month 3 | Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound. | Baseline and Month 3 | 
| Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 | Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100. | Baseline and Month 6 | 
| Percent Change From Baseline in the Serum DHT at Month 3 | Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100. | Baseline and Month 3 | 
| Change From Baseline in the Serum DHT at Month 6 | Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value. | Baseline and Month 6 | 
| Change From Baseline in the Serum DHT at Month 3 | Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value. | Baseline and Month 3 | 
| Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6 | Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35. | Baseline and Month 6 | 
| Percent Change From Baseline in the AUA-SI Score at Month 3 | Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35. | Baseline and Month 3 | 
| Change From Baseline in the AUA-SI Score at Month 6 | Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35. | Baseline and Month 6 | 
| Change From Baseline in the AUA-SI Score at Month 3 | Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35. | Baseline and Month 3 | 
| Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6 | Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter. | Baseline and Month 6 | 
| Percent Change From Baseline in Qmax at Month 3 | Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter. | Baseline and Month 3 | 
| Change From Baseline in Qmax at Month 6 | Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter. | Baseline and Month 6 | 
| Change From Baseline in Qmax at Month 3 | Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter. | Baseline and Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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placebo control, Chinese, Dutasteride, Randomized, Benign Prostatic Hyperplasia, Double blind