POMx In the Treatment of Erectile Dysfunction

Study Overview
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Brief Summary
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POMx can be used as a treatment for erectile dysfunction.

Official Title
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A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial to Evaluate the Safety and Efficacy of POM Wonderful Pomegranate Extract Capsules In Male Subjects With Moderate to Severe Erectile Dysfunction

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: Placebo
* Drug: One POMx capsule daily
* Drug: 2 POMx Capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>2 placebo capsules daily | Drug: Placebo<br>* 2 placebo capsules daily<br>|
| Experimental: one POMx capsule<br>One POMx capsule, one placebo capsule daily | Drug: One POMx capsule daily<br>* One POMx capsule, one placebo capsule daily<br>|
| Experimental: 2 POMx Capsules<br>2 POMx Capsules daily | Drug: 2 POMx Capsules<br>* 2 POMx Capsules daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on ED | 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 | Basedline to end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on ED | 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. | baseline to end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ED, POMx, Pomegranate, Erectile dysfunction