Erectile Dysfunction
Conditions
Keywords
ED, POMx, Pomegranate, Erectile dysfunction
Brief summary
POMx can be used as a treatment for erectile dysfunction.
Interventions
DRUGPlacebo
2 placebo capsules daily
DRUGOne POMx capsule daily
One POMx capsule, one placebo capsule daily
DRUG2 POMx Capsules
2 POMx Capsules daily
Sponsors
Target Health Inc.
POM Wonderful LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects on ED | Basedline to end of study | There are three co-primary endpoints: Erectile Function domain score (questions 1-5 and 15 of the IIEF), and questions 2 and 3 on the SEP diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect on ED | baseline to end of study | Secondary efficacy variables are: Total score on SEP and domains of the IIEF representing intercourse satisfaction (questions 6-8), orgasmic function (questions 9-10), and overall satisfaction (questions 11-12) and a Global Assessment Questionnaire. |
Countries
United States
Outcome results
None listed