Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
Open-label, 6 month-treatment with the IP in all subjects. - Sample size: A total of 90
 subjects will be enrolled so that among them at least 57 will complete the 6-month treatment
 period and evaluable for analysis.

 -Primary objective: To assess the safety of 0.5 mg dutasteride/0.4 mg tamsulosin combination
 therapy for six month in BPH patients by monitoring category, frequency and severity of
 adverse events encountered during the treatment period.

 -Secondary objective: To assess the efficacy of 0.5 mg dutasteride/0.4 mg tamsulosin
 combination therapy with regard to symptom improvement in BPH patients by monitoring and
 analyzing of changes in IPSS and Qmax after 6 months of treatment.
Visit 0 or Screening Visit (M0) - D0 + 2): Following tasks will be performed: ICF collection,
 subject code assignment, physical examination (vital signs, demographic data, medical
 history); checking of inclusion and exclusion criteria: prostate symptom score according to
 IPSS, laboratory tests (hematology, blood chemistry, electrolytes, total PSA level,
 free-to-total PSA ratio, Qmax, urinalysis, transrectal prostate ultrasonography (TRUS),
 12-lead electrocardiography (ECG), scoring of Sexual Function Questionnaire (SFQ),
 concomitant medication assessment, IP dispensing. • Visit 1 (Month 1 (M1) - D30 ± 3):
 Following items will be recorded: treatment compliance, vital signs, blood chemistry, ECG,
 adverse events (AEs), concomitant medication; dispensing of new IP doses and collecting of
 dispensed IP at the last visit. • Visit 2 (Month 2 (M2) - D60 ± 3): Following items will be
 recorded: treatment compliance, AEs, concomitant medication; dispensing of new IP doses and
 collecting of dispensed IP at the last visit. • Visit 3 (Month 3 (M3) - D90 ± 3): Following
 items will be recorded: vital signs, laboratory tests (hematology, blood chemistry,
 electrolytes, Qmax, urinalysis, 12-lead ECG, total PSA level), concomitant medication, SFQ
 score, AE assessment, collecting of dispensed IP at the last visit and dispensing of new IP
 doses. • Visit 4 (Month 4.5 (M4) - D135 ± 3): Following items will be recorded: treatment
 compliance, vital signs, AEs, concomitant medication; dispensing of new IP doses and
 collecting of dispensed IP at the last visit. Visit 5 (Month 6 (M6)- D180 ± 3): Following
 items will be recorded: treatment compliance, vital signs, prostate symptom score according
 to IPSS, laboratory tests (hematology, blood chemistry, electrolytes, Qmax, urinalysis,
 12-lead ECG, total PSA level, free-to-total PSA ratio, TRUS; concomitant medication, SFQ
 score, AE assessment, collecting of the previous dispensed IPs . Follow-up Phone Call (Month
 7 (M7)- D210 ± 3): To record any possible AE that may occur after discontinuation of study
 treatment.
Inclusion Criteria:

 Male, age ≥ 50 years. Clinical diagnosis of benign prostate hypertrophy (BPH) .
 International Prostate Symptom Score (IPSS) ≥ 12 Prostate volume ≥30 ml (transrectal
 ultrasonography). Total serum prostate specific antigen (PSA) ≥1.5 ng/mL and ≤10 ng/mL.
 Free-to-total PSA ratio > 20% Maximum flow rate (Qmax) >5 mL/sec and ≤15 mL/sec and
 post-void residual volume of < 150 mL Willing and able to give written informed consent and
 comply with study procedures throughout study Able to swallow and retain oral medication
 Able to express personal thought and feeling Ability to read and comprehend information on
 the Sexual Function Inventory

 Exclusion Criteria:

 History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious
 digital rectal examination).

 Previous prostatic surgery (TURP, balloon dilatation, thermotherapy and stent replacement)
 or other invasive procedures to treat BPH.

 History of flexible/rigid cystoscopy or other instrumentation of the urethra within past 7
 days History of acute urine retention (AUR) within past 3 months. Any causes other than BPH
 result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck
 contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or
 chronic urinary tract infections).

 History of breast cancer or clinical finding suggestive of malignancy. Use of any
 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®), drugs with antiandrogenic
 properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole,
 progestational agents), drugs which induce gynecomastia or drugs which affect prostate
 volume, within past 6 months and throughout the study (other than as study medication). Do
 not use dutasteride within past 12 months. Do not use metronidazole for a long time.

 Concurrent use of anabolic steroids (eg. Durabolin®). Use of phytotherapy (eg: Tadenan®,
 Permixon®, etc) for BPH within 2 weeks of screening visit and/or predicted to need
 phytotherapy during the study.

 Use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin,
 alfuzosin and doxazosin) within 2 weeks of screening visit and/or predicted to need any
 alpha blockers other than tamsulosin during the study.

 Use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine)
 or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol
 chloride) within 48 hours prior to all uroflowmetry assessments.

 Hypersensitivity to any alpha-/beta-adrenoreceptor blocker or 5-alpha-reductase inhibitor,
 or other chemically-related drugs.

 Concurrent use of drugs known or thought to have an interaction with tamsulosin and
 dutasteride.

 History of hepatic impairment or abnormal liver function tests at screening (defined ALT,
 AST, and/or alkaline phosphatase >2 times the upper limit of normal, or total bilirubin
 >1.5 times the upper limit of normal).

 History of renal insufficiency, or serum creatinine >1.5 times the upper limit of normal at
 screening.

 History of malignancies other than basal cell carcinoma or squamous cell carcinoma of the
 skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of
 disease for at least 5 years prior to screening are eligible.

 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, or cerebrovascular accident within past 6
 months; medically uncontrollable diabetes or peptic ulcer disease History of postural
 hypotension, dizziness, vertigo or any signs and symptoms of orthostasis, which in
 judgments of investigator, could be exacerbated by tamsulosin History of unsuccessful
 treatment with tamsulosin or 'first dose' hypotensive episode on initiation of
 alpha-1-adrenoreceptor antagonist therapy.

 History of unsuccessful treatment with finasteride or dutasteride. Willing to have a child
 during the treatment period or within 6 months thereafter Having female partner who is a
 pregnant woman or in child-bearing age and refuse to use condom for sexual protection
 Willing to donate blood during treatment period or within 6 months thereafter. History or
 current evidence of drug or alcohol abuse within past 12 months. History of any illness
 might confound the results of the study or poses additional risk to the patient.

 Participation in investigational or marketed drug trial within 30 days preceding the
 screening visit and/or during the study treatment