POMx In the Treatment of Erectile Dysfunction

Phase 2

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Placebo; Drug: One POMx capsule daily; Drug: 2 POMx Capsules

• Registration Number: NCT01220206
• Lead Sponsor: POM Wonderful LLC

Brief Summary

POMx can be used as a treatment for erectile dysfunction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-11
• Study First Submitted QC: 2010-10-11
• Study First Posted: 2010-10-13
• Study Start: 2011-08
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-04
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 placebo capsules daily
one POMx capsule	One POMx capsule daily	One POMx capsule, one placebo capsule daily
2 POMx Capsules	2 POMx Capsules	2 POMx Capsules daily

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Medical Affiliated Research Center; 🇺🇸 Huntsville, Alabama, United States