EndoPAT Device for Endothelial Dysfunction in ED
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, Irvine
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males 18 years old and above
Diagnosed with erectile dysfunction or hypogonadism
Disqualifiers
Patients without the above criteria
Trial design
Design model
Parallel
Treatments tested in this trial
Daily low-dose PDE5 inhibitor therapy
DrugNeither arm of the study includes a control group, and the two interventions will not be compared directly. The primary objective is to evaluate endothelial function using the EndoPAT device at baseline, 3 months, and 6 months following the intervention in each arm.
Testosterone therapy as per clinical guidelines.
DrugNeither arm of the study includes a control group, and the two interventions will not be compared directly. The primary objective is to evaluate endothelial function using the EndoPAT device at baseline, 3 months, and 6 months following the intervention.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)Active comparator 1 intervention
Group B: Testosterone Therapy in Hypogonadal MenActive comparator 1 intervention
Group C: Vasculogenic ED confirmed by penile Doppler ultrasoundNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Endothelial Function as Measured by Reactive Hyperemia Index (RHI)
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.
Time frame
At baseline, 3 months, and 6 months post-interventionSecondary outcomes
1
Cardiovascular Health Markers
Successful Outcome: Statistically significant improvements in blood pressure, lipid profile, and blood glucose levels from baseline to 3 and 6 months. Failure: No significant changes or worsening of cardiovascular health markers.
Time frame
From baseline to 3 months and 6 months post-intervention.2
Sexual Function Scores
Successful Outcome: Statistically significant improvement in IIEF scores from baseline to 3 and 6 months. Failure: No significant changes or deterioration in sexual function scores.
Time frame
From baseline to 3 months and 6 months post-intervention.3
Adverse Events
Successful Outcome: Minimal and non-severe adverse events reported. Failure: High frequency or severe adverse events necessitating discontinuation of the intervention.
Time frame
From baseline to 3 months and 6 months post-intervention.Sponsors and contacts
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Source ClinicalTrials.gov