Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID06720597

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

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Males 18 years old and above
  • Diagnosed with erectile dysfunction or hypogonadism
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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