POMx In the Treatment of Erectile Dysfunction

POM Wonderful

Status and phase: Completed; Phase 2

Conditions: Erectile Dysfunction

Treatments: Drug: 2 POMx Capsules; Drug: One POMx capsule daily; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01220206

POM 2010-003

Details and patient eligibility

About

POMx can be used as a treatment for erectile dysfunction.

Enrollment: 120 patients

Sex: Male

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

2 placebo capsules daily

Treatment:

Drug: Placebo

one POMx capsule

Experimental group

Description:

One POMx capsule, one placebo capsule daily

Treatment:

Drug: One POMx capsule daily

2 POMx Capsules

Experimental group

Description:

2 POMx Capsules daily

Treatment:

Drug: 2 POMx Capsules