POMx In the Treatment of Erectile Dysfunction

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220206
• Other study ID #: POM 2010-003
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2010
• Last updated: October 4, 2012
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: POM Wonderful LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

POMx can be used as a treatment for erectile dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Placebo
2 placebo capsules daily
• One POMx capsule daily
One POMx capsule, one placebo capsule daily
• 2 POMx Capsules
2 POMx Capsules daily

Locations

Country	Name	City	State
United States	Medical Affiliated Research Center	Huntsville	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
POM Wonderful LLC	Target Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No