Actively Recruiting
Utilizing EndoPAT Device for Endothelial Dysfunction Assessment in Erectile Dysfunction and Hormonal Therapy
Led by University of California, Irvine · Updated on 2026-02-02
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying endothelial dysfunction in men aged 30 to 50 who have vasculogenic erectile dysfunction (ED) confirmed by penile Doppler ultrasound. The study also investigates changes in endothelial function in men with hypogonadism before and after they begin testosterone therapy. The research aims to better understand how endothelial function is affected by ED and hormonal treatment and to fill gaps regarding the effects of PDE5 inhibitors and testosterone therapy on vascular health. Participants are divided into three groups: one group of men with vasculogenic ED receiving daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy, a second group of hypogonadal men receiving testosterone therapy following clinical guidelines, and a third group of men with vasculogenic ED who receive no intervention. Endothelial function is measured using the EndoPAT device at the start of the study and again at 3 and 6 months after treatment begins or baseline for the no-intervention group. Throughout the study, participants undergo assessments of endothelial function by Reactive Hyperemia Index (RHI) using EndoPAT, as well as evaluations of cardiovascular health markers, sexual function scores, and monitoring for adverse events at baseline and at 3 and 6 months follow-ups. The study is non-randomized and open-label, with a total participation duration of 6 months to evaluate changes over time in endothelial and cardiovascular health linked to ED and hormonal therapy.
CONDITIONS
Brief Title
EndoPAT Device for Endothelial Dysfunction in ED
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males 18 years old and above
- Diagnosed with erectile dysfunction or hypogonadism
You will not qualify if you...
- Patients without the above criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive daily low-dose PDE5 inhibitor therapy or testosterone therapy as per clinical guidelines, or no intervention depending on their group. Endothelial function is assessed using the EndoPAT device.
3 visits at baseline, 3 months, and 6 months (in-person)
Trial Site Locations
Total: 1 location
1
UCI Urology | Men's Health Center
Newport Beach, California, United States, 92660
Actively Recruiting
Research Team
M
Muhammed AM Hammad, MBBCh
E
Elia Abou Chawareb, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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