A Study in Benign Prostatic Hyperplasia

Lilly

Status and phase

Completed

Phase 3

Conditions

Benign Prostatic Hyperplasia

Treatments

Drug: Placebo

Drug: Tadalafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01152190

H6D-MC-LVIR (Other Identifier)

13469

Details and patient eligibility

About

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.

Enrollment

97 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.