Trial | NCT01220206  Report issue

Title

POMx In the Treatment of Erectile Dysfunction
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pomegranate ...

  • Study Participants

    120
POMx can be used as a treatment for erectile dysfunction.
Study Started
Aug 31
2011
Primary Completion
Oct 31
2012
Study Completion
Oct 31
2012
Last Update
Oct 05
2012
Estimate

Drug Placebo

2 placebo capsules daily

Drug One POMx capsule daily

One POMx capsule, one placebo capsule daily

Drug 2 POMx Capsules

2 POMx Capsules daily

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

Criteria 

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
No Results Posted