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| Name | Class |
|---|---|
| Target Health Inc. | INDUSTRY |
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POMx can be used as a treatment for erectile dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 2 placebo capsules daily |
|
| one POMx capsule | Experimental | One POMx capsule, one placebo capsule daily |
|
| 2 POMx Capsules | Experimental | 2 POMx Capsules daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 2 placebo capsules daily |
| |
| One POMx capsule daily |
| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| James McMurray, MD | Medical Affiliated Research Center, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center | Huntsville | Alabama | 35801 | United States |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Drug |
One POMx capsule, one placebo capsule daily |
|
| 2 POMx Capsules | Drug | 2 POMx Capsules daily |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |