Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Finasteride; Tamsulosin; Finasteride-matching placebo; Tamsulosin-matching placebo
Intervention description: Finasteride 5 mg oral tablet taken once daily.; Tamsulosin 0.2 mg oral capsule taken once daily.; Matching placebo to finasteride 5 mg oral tablet taken once daily.; Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.
Intervention MeSH terms: Tamsulosin; Finasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is designed to compare safety and efficacy of monotherapy finasteride to
      combination therapy (finasteride and tamsulosin) in Asian men with benign prostatic
      hyperplasia (BPH) who are at least 50 years of age or older. The primary hypotheses are that
      concomitantly-dosed finasteride 5 mg and tamsulosin 0.2 mg will be superior with respect to
      BPH symptoms compared to monotherapy with finasteride 5 mg as measured by change from
      baseline on the International Prostate Symptoms Score (IPSS) and will be superior with
      respect to prostate volume reduction compared to montherapy with tamsulosin 0.2 mg as
      measured by percent change from baseline in prostate volume.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Possess a clinical diagnosis of BPH.

          -  Able to read, understand, and complete the study questionnaire.

        Exclusion Criteria:

          -  History or recurrent evidence of any condition, therapy, lab abnormality or other
             circumstance that might confound the results of the study, or interfere with
             participation for the full duration of the study.

          -  History of malignancy ≤ 5 years prior to signing informed consent, except for
             adequately treated basal cell or squamous cell skin cancer, including prostate cancer
             of any duration, evidence or suspicion of prostate cancer on a previous biopsy.

          -  History of prostatic surgery or other invasive procedures to treat BPH or history of
             bladder neck obstruction, bladder cancer, and/or pelvic irradiation, urinary
             incontinence, recurrent urinary tract infection, urethral stricture, or bacterial
             prostatitis.

          -  History of acute urinary retention (ie, inability to fully empty bladder).

          -  Had invasive urinary bladder procedures (ie, cystoscopy) within 7 days prior to
             screening.

          -  Had phytotherapy within 2 weeks of screening and may need phytotherapy during the
             study.

          -  History of low blood pressure (orthostatic hypotension, hypotension [supine blood
             pressure less than 90/70 mm Hg]), unstable angina, or a cardiovascular or cerebral
             vascular event (ie, transient ischemic attack [TIA], stroke) within the previous 3
             months prior to enrollment, OR a history of dizziness, vertigo or any other typical
             signs and symptoms of low blood pressure.

          -  Recent history (ie, within the past year) or active addiction, abuse, misuse of and/or
             dependence on drugs and/or alcohol.

          -  Use of herbal therapies that may impact the study (eg, Saw Palmetto) within 2 weeks of
             screening and/or is predicted to need herbal therapies during the study. Individuals
             currently taking herbal therapies may be eligible for study if willing to complete a
             2-week washout period.

          -  Use of finasteride or a drug with a similar action during the 12 months prior to study
             screening. Individuals treated for short periods with 5-alpha reductase inhibitors
             (5ARIs) or drugs with antiandrogenic properties within 12 months of screening may be
             eligible for study.

          -  Use of a non-approved (investigational) drug within the last 4 weeks prior to
             enrollment, or current participation in another clinical study.

          -  Allergic or intolerant to finasteride and/or tamsulosin.