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POMx In the Treatment of Erectile Dysfunction

NCT ID: NCT01220206

Last Updated: 2012-10-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-10-31

Brief Summary

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POMx can be used as a treatment for erectile dysfunction.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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ED POMx Pomegranate Erectile dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

2 placebo capsules daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 placebo capsules daily

one POMx capsule

One POMx capsule, one placebo capsule daily

Group Type EXPERIMENTAL

One POMx capsule daily

Intervention Type DRUG

One POMx capsule, one placebo capsule daily

2 POMx Capsules

2 POMx Capsules daily

Group Type EXPERIMENTAL

2 POMx Capsules

Intervention Type DRUG

2 POMx Capsules daily

Interventions

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Placebo

2 placebo capsules daily

Intervention Type DRUG

One POMx capsule daily

One POMx capsule, one placebo capsule daily

Intervention Type DRUG

2 POMx Capsules

2 POMx Capsules daily

Intervention Type DRUG

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Target Health Inc.

INDUSTRY

Sponsor Role collaborator

POM Wonderful LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Other Identifiers

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POM 2010-003

Identifier Type: -

Identifier Source: org_study_id