Recruiting

PDE5 Inhibitor & Testosterone

Sponsor:

UCLA

Code:

NCT06720597

Conditions

Erectile Dysfunction

Hypogonadism, Male

Endothelial Dysfunction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Daily low-dose PDE5 inhibitor therapy

Testosterone therapy as per clinical guidelines.

Study Details

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

Study ID

NCT06720597

Start date

Aug 13, 2025

Status verified date

Jan, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients without the above criteria

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: 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.

no intervention: 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.

Interventions

Daily low-dose PDE5 inhibitor therapy

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.

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 outcome measure

  • Endothelial Function as Measured by Reactive Hyperemia Index (RHI) [ Time Frame: At baseline, 3 months, and 6 months post-intervention ]

Central Contacts and Locations

Central contacts

Muhammed AM Hammad, MBBCh

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

Elia Abou Chawareb, MD

714-456-7005eaboucha@hotmail.com

Locations

UCI Urology | Men's Health Center

Recruiting

Newport Beach, California, United States, 92660

Contacts

Muhammed AM Hammad, Mbbch

7144567005mahammad@hs.uci.edu

Elia Abou Chawareb, MD

7144567005eaboucha@hs.uci.edu

Principal Investigator:

Faysal A Yafi, MD

More Information

Sponsor

University of California, Irvine

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • EndoPAT
  • Erectile Dysfunction
  • Hypogonadism
  • Endothelial Dysfunction
  • ED
  • Testosterone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-02-02.