Safety and Efficacy of 0.5mg Dutasteride and 0.4mg Tamsulosin Combination Once Daily for Six Months for Benign Prostatic Hyperplasia
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Dutasteride/Tamsulosin
Intervention description: 0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment
Intervention MeSH terms: Tamsulosin; Dutasteride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Benign Prostatic Hyperplasia; dutasteride and tamsulosin

Summary:

      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.
    

Eligibility criteria:

        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