A Study in Benign Prostatic Hyperplasia

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men With Signs and Symptoms of Benign Prostatic Hyperplasia

The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.

Inclusion Criteria

• Present with benign prostatic hyperplasia
• Provide signed informed consent at the screening
• Agree not to use other treatment for Benign Prostatic Hyperplasia, Erectile Dysfunction or Overactive Bladder (including herbal treatments) during the study

Exclusion Criteria

• Have prostatic cancer or are being treated for cancer.
• Any condition that may negatively influence the transrectal ultrasound.
• Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
• Any evidence of moderate to severe cardiac disease
• Have had any of the following in the past 90 days: chest pain (called unstable angina or angina) that requires treatment, heart attack also known as myocardial infarction, heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to open up blood vessels in the heart know as angioplasty or stent placement (percutaneous coronary intervention), positive cardiac stress test without effective cardiac intervention.
• Have very high or very low blood pressure.
• Have uncontrolled diabetes.
• Have certain problems with your kidneys, liver, or nervous system.