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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: One POMx capsule daily; Drug: 2 POMx Capsules

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Medical Affiliated Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on ED	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	Basedline to end of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on ED	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.	baseline to end of study

Collaborators and Investigators

• Sponsor: POM Wonderful LLC
• Collaborators: Target Health Inc.
• Investigators: Principal Investigator: James McMurray, MD, Medical Affiliated Research Center, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 11, 2010
• First Submitted That Met QC Criteria: October 11, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): October 5, 2012
• Last Update Submitted That Met QC Criteria: October 4, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: ED; Pomegranate; Erectile dysfunction; POMx
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: POM 2010-003