Erectile DysfunctionPhase 2NCT01220206
POMx In the Treatment of Erectile Dysfunction
A Phase 2 study testing One POMx capsule daily and 2 POMx Capsules in people with Erectile Dysfunction, run by POM Wonderful LLC at 1 site in United States.
Trial summary
POMx can be used as a treatment for erectile dysfunction. Read more about this study
- Who is it for?
- Ages 21 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- One POMx capsule daily and 2 POMx Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Affiliated Research Center
Huntsville, Alabama, 35801
About this study
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
POMx can be used as a treatment for erectile dysfunction.
- Conditions
- Erectile Dysfunction
- Being tested
- Placebo, One POMx capsule daily, 2 POMx Capsules
- Keywords
- ED, POMx, Pomegranate, Erectile dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
2 placebo capsules daily
One POMx capsule dailyDrug
One POMx capsule, one placebo capsule daily
2 POMx CapsulesDrug
2 POMx Capsules daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 placebo capsules daily Receives: Drug: Placebo |
| one POMx capsule | Experimental | One POMx capsule, one placebo capsule daily Receives: Drug: One POMx capsule daily |
| 2 POMx Capsules | Experimental | 2 POMx Capsules daily Receives: Drug: 2 POMx Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Basedline to end of study
Secondary outcomes (1)
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.
Measured: baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- POM Wonderful LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Target Health Inc.
- Responsible party
- Sponsor
- Investigators
- James McMurray, MD, Principal investigator, Medical Affiliated Research Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220206
- Sponsor's protocol ID
- POM 2010-003
- Status last verified
- Oct 2012
- First submitted
- 11 Oct 2010
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01220206
- Acronym / sponsor ID
- POM 2010-003
- Conditions
- Erectile Dysfunction
- Keywords
- ED, POMx, Pomegranate, Erectile dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- POM Wonderful LLCIndustry (pharma, biotech, devices)
- Collaborators
- Target Health Inc.
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
POMx can be used as a treatment for erectile dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 placebo capsules daily |
| one POMx capsule | Experimental | Drug: One POMx capsule dailyOne POMx capsule, one placebo capsule daily |
| 2 POMx Capsules | Experimental | Drug: 2 POMx Capsules2 POMx Capsules daily |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo2 placebo capsules daily | Drug | Placebo |
| One POMx capsule dailyOne POMx capsule, one placebo capsule daily | Drug | one POMx capsule |
| 2 POMx Capsules2 POMx Capsules daily | Drug | 2 POMx Capsules |
Primary outcome
Effects on ED
Time frame: 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
1 secondary outcome
Effect on ED
Time frame: baseline to end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James McMurray, MD principal investigator
Medical Affiliated Research Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing One POMx capsule daily and 2 POMx Capsules in people with Erectile Dysfunction, run by POM Wonderful LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on ED (time frame: Basedline to end of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2012.