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EndoPAT Device for Endothelial Dysfunction in ED
N/A
Waitlist Available
Led By Faysal A Yafi, MD
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Males 18 years old and above
* Diagnosed with erectile dysfunction or hypogonadism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 3 months, and 6 months post-intervention
Awards & highlights
No Placebo-Only Group
Summary
To assess endothelial dysfunction in young men (aged 30-50) with vasculogenic ED identified through penile Doppler ultrasound. To evaluate changes in endothelial function using EndoPAT before and 3-6 months after daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy. To investigate endothelial function alterations in hypogonadal patients before and 3-6 months after initiating testosterone (T) therapy
Who is the study for?
This trial is for men aged 30-50 with vasculogenic erectile dysfunction (ED) diagnosed by penile Doppler ultrasound. It's specifically for those who have endothelial dysfunction, a condition affecting blood vessel health. Participants should also meet criteria for hypogonadism, where the body doesn't produce enough testosterone.
What is being tested?
The study tests how daily low-dose PDE5 inhibitors—drugs that help ED by increasing blood flow to the penis—and testosterone therapy affect blood vessel function in these patients. The EndoPAT device measures this function before and after treatment over a period of 3-6 months.
What are the potential side effects?
PDE5 inhibitors can cause headaches, flushing, upset stomach, nasal congestion, back pain, and dizziness. Testosterone therapy might lead to acne or oily skin, increased red blood cell count which can be risky for heart disease and mood swings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 3 months, and 6 months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 3 months, and 6 months post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Endothelial Function as Measured by Reactive Hyperemia Index (RHI)
Secondary study objectives
Adverse Events
Cardiovascular Health Markers
Sexual Function Scores
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)Active Control1 Intervention
Population: 40 men aged 18 or above years diagnosed with vasculogenic ED. Intervention: Daily low-dose PDE5 inhibitor therapy. Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.
Group II: Vasculogenic ED confirmed by penile Doppler ultrasoundActive Control1 Intervention
Population: 40 men aged 18 or above years diagnosed with vasculogenic ED. Intervention: None Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.
Group III: Testosterone Therapy in Hypogonadal MenActive Control1 Intervention
Population: 40 hypogonadal men aged 18 or above Intervention: Testosterone therapy as per clinical guidelines. Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.
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Who is running the clinical trial?
University of California, IrvineLead Sponsor
566 Previous Clinical Trials
1,932,958 Total Patients Enrolled
Faysal A Yafi, MDPrincipal InvestigatorUniversity of California, Irvine