EndoPAT Device for Endothelial Dysfunction in ED

Part of paid clinical trials in Newport Beach, California.

Sponsor
University of California, Irvine
Study ID
NCT06720597
Status
Recruiting
Apply to this trial

Conditions

  • Endothelial Dysfunction
  • Erectile Dysfunction
  • Hypogonadism, Male

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daily low-dose PDE5 inhibitor therapy — DRUG
    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.
  • Testosterone therapy as per clinical guidelines. — DRUG
    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.

Study Details

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

Key Dates

Start date
Aug 13, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)
    Population: 40 men aged 18 or above years diagnosed with vasculogenic ED. Intervention: Daily low-dose PDE5 inhibitor therapy. Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.
  • Active Comparator: Testosterone Therapy in Hypogonadal Men
    Population: 40 hypogonadal men aged 18 or above Intervention: Testosterone therapy as per clinical guidelines. Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.
  • No Intervention: Vasculogenic ED confirmed by penile Doppler ultrasound
    Population: 40 men aged 18 or above years diagnosed with vasculogenic ED. Intervention: None Assessments: Endothelial function will be assessed using the EndoPAT device at baseline, 3 months, and 6 months post-intervention.

Primary Outcome Measure

Endothelial Function as Measured by Reactive Hyperemia Index (RHI) [ Time Frame: At baseline, 3 months, and 6 months post-intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCI Urology | Men's Health CenterNewport BeachCalifornia92660
Muhammed AM Hammad, Mbbch
[email protected]
7144567005
Elia Abou Chawareb, MD
[email protected]
7144567005
Faysal A Yafi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Newport Beach, CA

By research site
UCI Urology | Men's Health Center· Newport Beach, CA

Related Studies