A Study in Benign Prostatic Hyperplasia

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Tadalafil

Criteria

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.