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
  Purpose

POMx can be used as a treatment for erectile dysfunction.


Condition Intervention Phase
Erectile Dysfunction
Drug: Placebo
Drug: One POMx capsule daily
Drug: 2 POMx Capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by POM Wonderful LLC:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 120
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
2 placebo capsules daily
Drug: Placebo
2 placebo capsules daily
Experimental: one POMx capsule
One POMx capsule, one placebo capsule daily
Drug: One POMx capsule daily
One POMx capsule, one placebo capsule daily
Experimental: 2 POMx Capsules
2 POMx Capsules daily
Drug: 2 POMx Capsules
2 POMx Capsules daily

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220206

Locations
United States, Alabama
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
Sponsors and Collaborators
POM Wonderful LLC
Target Health Inc.
Investigators
Principal Investigator: James McMurray, MD Medical Affiliated Research Center, Inc.
  More Information

No publications provided

Responsible Party: POM Wonderful LLC
ClinicalTrials.gov Identifier: NCT01220206     History of Changes
Other Study ID Numbers: POM 2010-003
Study First Received: October 11, 2010
Last Updated: October 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by POM Wonderful LLC:
ED
POMx
Pomegranate
Erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014