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

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemia

This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.

Inclusion criteria:

• Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
• Stable heterosexual relationship for more than 6 months.
• The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary: Was sexual activity initiated with the intention of intercourse?) on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary [at least one question should be answered "No"]: Were you able to achieve at least some erection (some enlargement of the penis)? Were you able to insert your penis into your partner's vagina? Did your erection last long enough for you to have successful intercourse?
• Diagnosis of dyslipidemia treated with a stable dose of a statin for 6 months at Visit 1.
• IIEF-EF domain score of 25 denoting mild to severe ED at Visit 2.
• Documented, dated, written Informed Consent.

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.