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