POMx In the Treatment of Erectile Dysfunction

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

POMx can be used as a treatment for erectile dysfunction.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: POM Wonderful LLC
• Collaborator: Target Health Inc.

Criteria

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