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

GlaxoSmithKline253 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

253

Conditions

Benign Prostatic Hyperplasia Prostatic Hyperplasia

Interventions

Dutasteride 0.5mg capsuleDRUG

Dutasteride 0.5mg once daily orally

Dutasteride matched placeboDRUG

Dutasteride matched placebo once daily orally

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (12)

GSK Investigational Site

Guangzhou, Guangdong, China

GSK Investigational Site

Wuhan, Hubei, China

GSK Investigational Site

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Month 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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