EndoPAT Device for Endothelial Dysfunction in ED
NCT06720597 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-02-02
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
Conditions
- Erectile Dysfunction
- Hypogonadism, Male
- Endothelial Dysfunction
Interventions
- DRUG
-
Daily low-dose PDE5 inhibitor therapy
Neither 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.
- DRUG
-
Testosterone therapy as per clinical guidelines.
Neither 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.
Sponsors & Collaborators
-
University of California, Irvine
lead OTHER
Principal Investigators
-
Faysal A Yafi, MD · University of California, Irvine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-13
- Primary Completion
- 2027-01-31
- Completion
- 2027-01-31
Countries
- United States
Study Locations
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