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