PDE5 Inhibitor + Testosterone Therapy for Erectile Dysfunction

Recruiting in Palo Alto (17 mi)

Overseen byFaysal Yafi, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, Irvine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Faysal Yafi, MD

Principal Investigator

University of California, Irvine

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

Patients without the above criteria

Treatment Details

Interventions

Daily low-dose PDE5 inhibitor therapy (Phosphodiesterase Inhibitor)
Testosterone therapy (Hormone Therapy)

Trial OverviewThe 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.

Participant Groups

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.