EndoPAT Device for Endothelial Dysfunction in ED

NCT06720597 | Recruiting

• 1 other identifier: 5526
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EndoPAT; Erectile Dysfunction; Hypogonadism; Endothelial Dysfunction; ED; Testosterone

Outcome Measures

Primary Outcomes (1)

• Endothelial Function as Measured by Reactive Hyperemia Index (RHI)

  Definition: RHI is a measure of endothelial function derived from the EndoPAT device, which assesses the endothelium's ability to respond to induced hyperemia. Measurement: RHI is calculated based on the changes in digital pulse volume during reactive hyperemia following a 5-minute arterial occlusion. Criteria for Evaluation: Baseline RHI: Measured before any intervention. Post-Intervention RHI: Measured at 3 months and 6 months post-intervention. Improvement in RHI: Defined as an increase in RHI scores from baseline to follow-up measurements.

  At baseline, 3 months, and 6 months post-intervention

Secondary Outcomes (3)

• Cardiovascular Health Markers

  From baseline to 3 months and 6 months post-intervention.

• Sexual Function Scores

  From baseline to 3 months and 6 months post-intervention.

• Adverse Events

  From baseline to 3 months and 6 months post-intervention.

Study Arms (3)

PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)

ACTIVE COMPARATOR

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.

Drug: Daily low-dose PDE5 inhibitor therapy

Testosterone Therapy in Hypogonadal Men

ACTIVE COMPARATOR

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.

Drug: Testosterone therapy as per clinical guidelines.

Vasculogenic ED confirmed by penile Doppler ultrasound

NO INTERVENTION

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.

Interventions

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.

Testosterone Therapy in Hypogonadal Men

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.

PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males 18 years old and above
• Diagnosed with erectile dysfunction or hypogonadism

You may not qualify if:

• Patients without the above criteria

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

UCI Urology | Men's Health Center

Newport Beach, California, 92660, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Eunuchism; Hypogonadism

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Faysal A Yafi, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammed AM Hammad, MBBCh

CONTACT

714-456-7005; mahammad@hs.uci.edu

Elia Abou Chawareb, MD

CONTACT

714-456-7005; eaboucha@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The data analysis will be conducted by statisticians blinded to the intervention status to reduce analysis bias. Data coding will be used to ensure that statisticians are unaware of the group assignments during the analysis phase.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology Director of Men's Health and Newport Urology Chief, Division of Men's Health and Reconstructive Urology

Model Details: Study groups: 1. 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. 2. 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. 3. 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.

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: August 13, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)