Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2011-08-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
2 placebo capsules daily
Placebo
2 placebo capsules daily
one POMx capsule
One POMx capsule, one placebo capsule daily
One POMx capsule daily
One POMx capsule, one placebo capsule daily
2 POMx Capsules
2 POMx Capsules daily
2 POMx Capsules
2 POMx Capsules daily
Interventions
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Placebo
2 placebo capsules daily
One POMx capsule daily
One POMx capsule, one placebo capsule daily
2 POMx Capsules
2 POMx Capsules daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
70 Years
MALE
No
Sponsors
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Target Health Inc.
INDUSTRY
POM Wonderful LLC
INDUSTRY
Responsible Party
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Principal Investigators
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James McMurray, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Affiliated Research Center, Inc.
Locations
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Medical Affiliated Research Center
Huntsville, Alabama, United States
Countries
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Other Identifiers
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POM 2010-003
Identifier Type: -
Identifier Source: org_study_id
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