POMx In the Treatment of Erectile Dysfunction

• Sponsor: POM Wonderful LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01220206
• Collaborator: Target Health Inc. (Industry)
• Enrollment: 120
• Location: 1
• Arms: 3
• Duration (Months): 14
• Patients Per Site Per Month: 8.6

Study Details

Study Description

Brief Summary

POMx can be used as a treatment for erectile dysfunction.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Placebo; Drug: One POMx capsule daily; Drug: 2 POMx Capsules	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Effects on ED [Basedline to end of study]

   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

1. Effect on ED [baseline to end of study]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: POM Wonderful LLC
• ClinicalTrials.gov Identifier: NCT01220206
• Other Study ID Numbers: POM 2010-003
• First Posted: Oct 13, 2010
• Last Update Posted: Oct 5, 2012
• Last Verified: Oct 1, 2012

• Keywords provided by POM Wonderful LLC: ED; POMx; Pomegranate; Erectile dysfunction
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of Oct 5, 2012