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Therapeutic Areas: Nephrology/Urology
Disease Category: Prostate Disorders

Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men with Both Erectile Dysfunction and Benign Prostatic Hyperplasia

Are you a man with Enlarged Prostate, BPH symptoms - and you also have erectile dysfunction or ED? These two conditions, ED and BPH, often occur together for Men over 45 and there is a new research study evaluating a marketed medication in an investigational use for Erectile Dysfunction and the frequent, interrupted or difficult urination symptoms of BPH. West Coast Clinical Research is conducting this study. Call them today at 818-776-0820 to see if you may be a candidate for this ED/BPH study. To be eligible, you must be a male, forty-five years or older with both ED and Enlarged Prostate, BPH symptoms. If you qualify, all study-related care will be provided at no cost, including study related exams and study medication - and financial compensation will also be provided for time and travel. Call West Coast Clinical Research at 818-776-O820 to determine if you may qualify for this ED/Enlarged Prostate study.

To be in this study, you should:

• Be a male, at least 45 years old and have at least a three (3) month history of ED and six (6) month history of BPHand are willing to participate in this study
• Have the same adult female sexual partner during the study who is willing to participate in the required number of intercourse attempts during the study
• Agree to not use any other treatment for BPH, ED, or OAB (overactive bladder), including herbal treatments, during the study
• Agree to make at least four (4) attempts at sexual intercourse with your female sexual partner between Visit 2 and Visit 3

You cannot participate in this study if you:

• Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin)
• Have certain problems with your kidneys, liver, or nervous system. (Your study doctor will discuss this with you).
• Have chest pain (called unstable angina or angina) that requires treatment
• Have heart disease that causes symptoms after you exert yourself
• Have had any of the following in the past 90 days:
  • Heart attack (myocardial infarction)
  • Heart bypass surgery (coronary artery bypass graft surgery)
  • A procedure to open up blood vessels in the heart (angioplasty) or stent placement
• Have uncontrolled high or low blood pressure
• Have uncontrolled diabetes (also known as sugar diabetes)
• Have had a stroke or a significant injury to your brain or spinal cord
• Have prostate cancer or are being treated for cancer
• Are an employee of the investigative site or you are an immediate family member of an employee of the investigative site. Immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted
• Are an employee of Eli Lilly and Company (that is, employees, temporary contract workers, or designees responsible for the conduct of the study) and their immediate families

Michele Pleasant, Patient Recruitment Specialist
West Coast Clinical Research
5525 Etiwanda Ave., Suite 202
Tarzana, CA 91356
Phone: 818-776-0820, Ext. 101
Fax: 818-776-1269
EMail: mpleasant@wccresearch.com

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