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NCT Number: NCT06720597

EndoPAT Device for Endothelial Dysfunction in ED

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

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Key information

Conditions

Erectile Dysfunction Endocrine System Diseases Endothelial Dysfunction Eunuchism Genital Diseases Genital Diseases, Male Gonadal Disorders Hypogonadism Hypogonadism, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCI Urology | Men's Health Center

Newport Beach, California, 92660, United States

Location status: Recruiting

Location contact

Elia Abou Chawareb, MD

CONTACT

[email protected]

7144567005

Faysal A Yafi, MD

PRINCIPAL_INVESTIGATOR

Muhammed AM Hammad, Mbbch

CONTACT

[email protected]

7144567005

About this study

Endothelial Dysfunction and Cardiovascular Health: Endothelial dysfunction is characterized by impaired endothelium-dependent vasodilation, which is a critical factor in the development and progression of cardiovascular diseases. The endothelium, the thin layer of cells lining blood vessels, plays a pivotal role in vascular health by regulating blood flow, coagulation, and immune function. When the endothelium is not functioning properly, it can lead to a range of cardiovascular conditions, including atherosclerosis, hypertension, and erectile dysfunction (ED).

Erectile Dysfunction and Endothelial Dysfunction: ED is often an early marker of endothelial dysfunction and cardiovascular diseases. Vasculogenic ED, in particular, is linked to poor endothelial health, where impaired blood flow to the penile tissue results in the inability to achieve or maintain an erection. This condition shares common risk factors with other cardiovascular diseases, such as diabetes, hypertension, and hyperlipidemia, highlighting the interconnected nature of endothelial health and ED.

Hormonal Therapy and Endothelial Function: Testosterone therapy (T therapy) is commonly used to treat hypogonadism in men, a condition characterized by low testosterone levels. Hypogonadism itself is associated with an increased risk of cardiovascular diseases, and testosterone therapy has been shown to have varying effects on endothelial function. While some studies suggest that testosterone may improve endothelial health, others indicate potential risks, necessitating further research to clarify its impact.

Current Gaps in Knowledge:

Prevalence of Endothelial Dysfunction in Young Men with ED: While the association between endothelial dysfunction and ED is established, there is a need for precise data on the prevalence and extent of endothelial dysfunction specifically in young men with vasculogenic ED. Understanding this prevalence can inform targeted treatment strategies.

Impact of PDE5 Inhibitors on Endothelial Function: Phosphodiesterase type 5 (PDE5) inhibitors are a first-line treatment for ED, known to improve erectile function by enhancing blood flow. However, their direct impact on endothelial function over time remains underexplored, particularly in terms of long-term cardiovascular outcomes.

Effects of Testosterone Therapy on Endothelial Health: The influence of testosterone therapy on endothelial function in hypogonadal men is not well understood. There is conflicting evidence on whether testosterone therapy confers cardiovascular benefits or risks, necessitating comprehensive studies to determine its effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients without the above criteria

Treatment and study plan

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.

Primary outcomes

  1. Endothelial Function as Measured by Reactive Hyperemia Index (RHI)

    Time frame: At baseline, 3 months, and 6 months post-intervention

    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.

Secondary outcomes

  1. Cardiovascular Health Markers

    Time frame: From baseline to 3 months and 6 months post-intervention.

    Successful Outcome: Statistically significant improvements in blood pressure, lipid profile, and blood glucose levels from baseline to 3 and 6 months.

    Failure: No significant changes or worsening of cardiovascular health markers.

  2. Sexual Function Scores

    Time frame: From baseline to 3 months and 6 months post-intervention.

    Successful Outcome: Statistically significant improvement in IIEF scores from baseline to 3 and 6 months.

    Failure: No significant changes or deterioration in sexual function scores.

  3. Adverse Events

    Time frame: From baseline to 3 months and 6 months post-intervention.

    Successful Outcome: Minimal and non-severe adverse events reported. Failure: High frequency or severe adverse events necessitating discontinuation of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Elia Abou Chawareb, MD

CONTACT

[email protected]

714-456-7005

Muhammed AM Hammad, MBBCh

CONTACT

[email protected]

714-456-7005

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Utilizing EndoPAT Device for Endothelial Dysfunction Assessment in Erectile Dysfunction and Hormonal Therapy

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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