EndoPAT Device for Endothelial Dysfunction in ED
This study is looking at how two different treatments affect blood vessel health in men with erectile dysfunction (ED) or low testosterone (hypogonadism). Researchers will use a special device called EndoPAT to measure your endothelial function (how well your blood vessels work) at the beginning of the study, and then again at 3 and 6 months after treatment. One group will receive daily low-dose PDE5 inhibitor therapy, and another group will receive testosterone therapy. The study aims to see if these treatments improve blood vessel health. This study is currently unclear in its recruitment status and plans to enroll 120 men.
- Study design
- This interventional study plans to enroll 120 men. There are two treatment groups, but they are not directly compared to each other.
- What's involved
- You would have your endothelial function measured using the EndoPAT device at the start of the study, and then again at 3 months and 6 months after starting your assigned treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 6 months after starting their intervention to measure endothelial function.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
EndoPAT Device for Endothelial Dysfunction in ED
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Faysal A Yafi, MD · PRINCIPAL_INVESTIGATOR · University of California, Irvine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Endothelial Function as Measured by Reactive Hyperemia Index (RHI)At baseline, 3 months, and 6 months post-intervention
Definition: RHI is a measure of endothelial function derived from the EndoPAT device, which assesses the endothelium's ability to respond to induced hyperemia. Measurement: RHI is calculated based on the changes in digital pulse volume during reactive hyperemia following a 5-minute arterial occlusion. Criteria for Evaluation: Baseline RHI: Measured before any intervention. Post-Intervention RHI: Measured at 3 months and 6 months post-intervention. Improvement in RHI: Defined as an increase in RHI scores from baseline to follow-up measurements.