POMx In the Treatment of Erectile Dysfunction

Inclusion Criteria: Male 21 to 70 years old Erectile Function domain score of 10-19 on the International Index of Erectile Function (IIEF) In a stable, monogamous relationship with a consenting female partner and willing to attempt vaginal sexual intercourse on at least one occasion per week on average during each study period History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration Treated previously with a PDE-5 inhibitor with a satisfactory response, as defined by the patient. Signed informed consent Exclusion Criteria: -The presence of any of the following excludes a subject from study enrollment: ED caused by untreated endocrine disease, i.e., hypopituitarism, hypothyroidism, hypogonadism A diagnosis of situational psychogenic ED Significant penile pathology, including but not limited to curvature, fibrosis, sexually transmitted disease, and penile implant Clinically significant hepatic, renal, neurological disease, diabetes mellitus, spinal cord injury, significant coronary heart disease, significant neurological disease or hepatitis B and/or C History of prostate cancer or prostate surgery other than a transurethral resection of the prostate History of alcoholism within the previous 2 years Current consumer of three or more units of alcohol per day (1 unit is equivalent to 1 glass of wine, 1 pint of beer, or 1 shot of hard liquor) Taking ED therapy (prescription medications, over-the-counter medications, herbal preparations or medical devices) after the screening visit Participation in another study with an investigational drug or device during the 30 days prior to study entry Has a condition interfering with his ability to provide informed consent or comply with study instructions