← Back to Search

PDE5 Inhibitor + Testosterone Therapy for Erectile Dysfunction

N/A

Waitlist Available

Led By Faysal A Yafi, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males 18 years old and above diagnosed with erectile dysfunction or hypogonadism

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, 3 months, and 6 months post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how blood vessel function is affected in young men with erectile dysfunction. They will use ultrasound to identify men with blood vessel-related ED and then give them either a low-dose medication

Who is the study for?

This trial is for men aged 30-50 with vasculogenic erectile dysfunction (ED) diagnosed by penile Doppler ultrasound. It's specifically for those who have endothelial dysfunction, a condition affecting blood vessel health. Participants should also meet criteria for hypogonadism, where the body doesn't produce enough testosterone.

What is being tested?

The study tests how daily low-dose PDE5 inhibitors—drugs that help ED by increasing blood flow to the penis—and testosterone therapy affect blood vessel function in these patients. The EndoPAT device measures this function before and after treatment over a period of 3-6 months.

What are the potential side effects?

PDE5 inhibitors can cause headaches, flushing, upset stomach, nasal congestion, back pain, and dizziness. Testosterone therapy might lead to acne or oily skin, increased red blood cell count which can be risky for heart disease and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man over 18 with erectile dysfunction or low testosterone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 3 months, and 6 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 3 months, and 6 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 3 months, and 6 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endothelial Function as Measured by Reactive Hyperemia Index (RHI)

Secondary study objectives

Adverse Events

Cardiovascular Health Markers

Sexual Function Scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED)Active Control1 Intervention

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.

Group II: Vasculogenic ED confirmed by penile Doppler ultrasoundActive Control1 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.

Group III: Testosterone Therapy in Hypogonadal MenActive Control1 Intervention

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.

0 / 1Eligibility criteria met