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POMx In the Treatment of Erectile Dysfunction

This study has been completed.
Sponsor:
Collaborator:
Target Health Inc.
Information provided by (Responsible Party):
POM Wonderful LLC
ClinicalTrials.gov Identifier:
NCT01220206
First received: October 11, 2010
Last updated: October 4, 2012
Last verified: October 2012
History of Changes

October 11, 2010
October 4, 2012
August 2011
October 2012   (final data collection date for primary outcome measure)
Effects on ED [ Time Frame: Basedline to end of study ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01220206 on ClinicalTrials.gov Archive Site
Effect on ED [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
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

POMx can be used as a treatment for erectile dysfunction.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Erectile Dysfunction
  • 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 Comparator: Placebo
    2 placebo capsules daily
    Intervention: Drug: Placebo
  • Experimental: one POMx capsule
    One POMx capsule, one placebo capsule daily
    Intervention: Drug: One POMx capsule daily
  • Experimental: 2 POMx Capsules
    2 POMx Capsules daily
    Intervention: Drug: 2 POMx Capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Male
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01220206
POM 2010-003
No
POM Wonderful LLC
POM Wonderful LLC
Target Health Inc.
Principal Investigator: James McMurray, MD Medical Affiliated Research Center, Inc.
POM Wonderful LLC
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP