EndoPAT to measure blood vessel health in men with erectile dysfunction and hypogonadism
Utilizing EndoPAT Device for Endothelial Dysfunction Assessment in Erectile Dysfunction and Hormonal Therapy
NA · University of California, Irvine · NCT06720597
This project will test whether EndoPAT can detect changes in blood-vessel function in men with vasculogenic ED or hypogonadism before and 3–6 months after starting daily low-dose PDE5 inhibitors or testosterone therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, Irvine (other) |
| Locations | 1 site (Newport Beach, California) |
| Trial ID | NCT06720597 on ClinicalTrials.gov |
What this trial studies
The trial uses EndoPAT, a noninvasive device that measures endothelial (blood-vessel) function, to obtain baseline readings and repeat measurements 3–6 months after treatment. Men with vasculogenic erectile dysfunction are identified by penile Doppler ultrasound, while hypogonadal men are enrolled prior to initiating testosterone therapy. Interventions include daily low-dose PDE5 inhibitor therapy for vasculogenic ED and guideline-based testosterone therapy for hypogonadism, with EndoPAT comparisons pre- and post-treatment. The single-center study is conducted at the UCI Urology | Men's Health Center in Newport Beach, California.
Who should consider this trial
Good fit: Men diagnosed with vasculogenic erectile dysfunction (typically identified by penile Doppler, often age 30–50) or men diagnosed with hypogonadism who are planning to start testosterone therapy are ideal candidates.
Not a fit: Men whose ED is not vascular in origin (for example, purely psychogenic or neurogenic causes), those not starting the specified therapies, or those unable to attend follow-up visits are unlikely to gain direct benefit from participation.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive way to monitor vascular health and treatment response in men with ED or hypogonadism, helping guide therapy decisions.
How similar studies have performed: EndoPAT has been used in prior studies to measure endothelial function and some research suggests PDE5 inhibitors can improve endothelial markers, while testosterone’s effects have been mixed, so aspects are supported by prior work but the specific patient focus and timeline are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males 18 years old and above * Diagnosed with erectile dysfunction or hypogonadism Exclusion Criteria: * Patients without the above criteria
Where this trial is running
Newport Beach, California
- UCI Urology | Men's Health Center — Newport Beach, California, United States (RECRUITING)
Study contacts
- Principal investigator: Faysal A Yafi, MD — University of California, Irvine
- Study coordinator: Muhammed AM Hammad, MBBCh
- Email: mahammad@hs.uci.edu
- Phone: 714-456-7005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Erectile Dysfunction, Hypogonadism, Male, Endothelial Dysfunction, EndoPAT, Hypogonadism, ED, Testosterone