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
1 other identifier
interventional
120
1 country
1
Brief Summary
POMx can be used as a treatment for erectile dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2011
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 5, 2012
October 1, 2012
1.2 years
October 11, 2010
October 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Effect on ED
baseline to end of study
Study Arms (3)
Placebo
PLACEBO COMPARATOR2 placebo capsules daily
one POMx capsule
EXPERIMENTALOne POMx capsule, one placebo capsule daily
2 POMx Capsules
EXPERIMENTAL2 POMx Capsules daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- POM Wonderful LLClead
- Target Health Inc.collaborator
Study Sites (1)
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James McMurray, MD
Medical Affiliated Research Center, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2010
First Posted
October 13, 2010
Study Start
August 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 5, 2012
Record last verified: 2012-10