Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
Condition: Benign Prostatic Hyperplasia; Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Dutasteride 0.5mg capsule; Dutasteride matched placebo
Intervention description: Dutasteride 0.5mg once daily orally; Dutasteride matched placebo once daily orally
Intervention MeSH terms: Dutasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 253.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: placebo control; Chinese; Dutasteride; Randomized; Benign Prostatic Hyperplasia; Double blind

Summary:

      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
    

Eligibility criteria:

        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.