Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
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.
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.