A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia

Exclusion Criteria

• •Premature ejaculator \<2 minutes
• •Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities, or substance abuse disorder that MD feels subject will not be able to complete the study.
• •Low sexual desire.
• •Prior prostatectomy surgery
• •Severe chronic or acute liver disease, history of moderate or severe liver impairment
• •Clinically significant chronic hematological disease
• •Bleeding disorder or significant active peptic ulceration.
• •Cardiovascular conditions that prevent sexual activity.
• •History of heart attack, stroke, or life-threatening arrhythmia within the prior 6 months.
• •hypotension or hypertension at rest.
• •cancer within the past 5 years. Use of these medications: nitrates or nitric oxide donors, anti-androgens, oral or injectable androgens, received any investigational drug (including placebo) within 30 days of screening (Visit 1).
• •Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
• •Subjects who are taking the following potent inhibitors of cytochrome P-450 3A4.
• •Abnormal Laboratory Values:
• •1. serum total testosterone level \>25% below the lower limit of normal
• •2. serum creatinine \>3.0 mg/dl.
• •3. AST and/or ALT \>3x the upper limit of normal.