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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Genital Diseases, Male
Mental Disorders
Sexual and Gender Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological

ClinicalTrials.gov processed this record on October 21, 2014