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Therapeutic Areas: Nephrology/Urology
Disease Category: Prostate Disorders

Trial Information

A Randomized,Double-Blind, Placebo-Controlled, Parallel-Design, 5-Group, Multinational Study to Evaluate the Efficacy, Dose Response, and Safety of Tadalafil Once-a-day Dosing for 12 Weeks in Men with Signs and Symptoms of Benign Prostatic Hyperplasia.

This is a randomized, double-blind, placebo-controlled multicenter study to evaluate if the study drug, tadalafil, will improve the signs and symptoms of enlarged prostate gland (also known as benign prostatic hyperplasia or BPH). This study will also aim to show the safety of tadalafil and to see what dose of tadalafil (2.5mg, 5mg, 10mg, 20mg) taken once a day will help improve the symptoms of BPH.
Compensation Provided

Patient Inclusion/Exclusion Criteria:

To be in the study, you should:
- Be at least 45 years or older
- Have had signs and symptoms of BPH for at least 6 months. These include:frequent & urgent need to urinate, trouble starting or maintaining a urine stream, urinating a small amount, feeling of needing to urinate again even after just finished urinating, and leaking or dribbling of urine.
- Have problems with urine flow.
- Agree not to use any other treatments for BPH, including alpha blockers or herbal preparations during the study.
- Agree not to use any other oral treatment for erectile dysfunction (ED), including herbal medications during the study.

You cannot participate in this study if you:
- Are taking certain medications, called nitrates (nitroglycerin) for heart disease.
- Have a urinary tract infection, are unable to urinate due to blockage, or have a large amount of urine remaining in your bladder after urinating.
- Have a significant kidney problem or liver problem.
- Have chest pain, called unstable angina or angina, requiring medical treatment.
- Have heart disease where less than ordinary activity causes you to have symptoms.
- Have history of any of the following coronary conditions in the past 90 days: heart attack also known as myocardial infarction; heart bypass surgery called coronary artery bypass graft surgery; percutaneous coronary intervention such as angioplasty or stent placement.
- Have uncontrolled high or low blood pressure.
- Have uncontrolled diabetes (&qout;sugar diabetes&qout;).
- Have had a stroke or a significant injury to the spine.
- Are being treated for cancer.

Lourdes Campos-Grundvig, RN
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Phone: (212) 241-3141
Fax: (212) 876-3246
EMail: lourdes.campos-grundvig@mssm.edu

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