Clinical trial NCT06720597: EndoPAT Device for Endothelial Dysfunction in ED
Official title: Utilizing EndoPAT Device for Endothelial Dysfunction Assessment in Erectile Dysfunction and Hormonal Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Erectile Dysfunction
Hypogonadism, Male
Endothelial Dysfunction
Keywords: EndoPAT
Erectile Dysfunction
Hypogonadism
Endothelial Dysfunction
ED
Testosterone
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients without the above criteria

Primary outcomes:
measure: Endothelial Function as Measured by Reactive Hyperemia Index (RHI)
timeFrame: At baseline, 3 months, and 6 months post-intervention
Secondary outcomes:
measure: Cardiovascular Health Markers
timeFrame: From baseline to 3 months and 6 months post-intervention.
measure: Sexual Function Scores
timeFrame: From baseline to 3 months and 6 months post-intervention.
measure: Adverse Events
timeFrame: From baseline to 3 months and 6 months post-intervention.
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: UCI Urology | Men's Health Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Faysal A Yafi, MD
role: PRINCIPAL_INVESTIGATOR
References: