Status:
COMPLETED
POMx In the Treatment of Erectile Dysfunction
Lead Sponsor:
POM Wonderful LLC
Collaborating Sponsors:
Target Health Inc.
Conditions:
Erectile Dysfunction
Eligibility:
MALE
21-70 years
Phase:
PHASE2
Brief Summary
POMx can be used as a treatment for erectile dysfunction.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01220206
Start Date
August 1 2011
End Date
October 1 2012
Last Update
October 5 2012
Active Locations (1)
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1
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801