PDE5 Inhibitor + Testosterone Therapy for Erectile Dysfunction

Overseen By Elia Abou Chawareb, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Irvine

Must be taking: PDE5 inhibitors, Testosterone

Disqualifiers: Females, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug combination of PDE5 inhibitors and testosterone therapy for erectile dysfunction?

Research suggests that combining testosterone therapy with PDE5 inhibitors can improve erectile function in men with low testosterone levels who do not respond well to PDE5 inhibitors alone. This combination may enhance sexual function and increase testosterone levels, leading to better outcomes for men with erectile dysfunction. ^{1 2 3 4 5}

Is the combination of PDE5 inhibitors and testosterone therapy safe for humans?

The combination of PDE5 inhibitors and testosterone therapy is generally considered safe for humans, as studies suggest it can improve erectile dysfunction in men with low testosterone levels. However, the research has some limitations, and the safety of this combination therapy should be discussed with a healthcare provider. ^{1 2 3 4 5}

How does the combination of PDE5 inhibitors and testosterone therapy differ from other erectile dysfunction treatments?

This treatment is unique because it combines PDE5 inhibitors, which help increase blood flow to the penis, with testosterone therapy, which can enhance sexual function in men with low testosterone levels who do not respond well to PDE5 inhibitors alone. This combination may be particularly beneficial for men with erectile dysfunction and low testosterone, offering improved outcomes compared to using PDE5 inhibitors by themselves. ^{1 2 4 5 6}

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.

Exclusion Criteria

Patients without the above criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily low-dose PDE5 inhibitor therapy or testosterone therapy, with endothelial function assessed using the EndoPAT device

6 months

Assessments at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cardiovascular health markers and sexual function scores

6 months

Treatment Details

Interventions

• Daily low-dose PDE5 inhibitor therapy
• Testosterone therapy

Trial Overview 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.

Participant Groups

Group I: PDE5 Inhibitor Therapy in Men with Vasculogenic Erectile Dysfunction (ED) Active Control 1 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 ultrasound Active Control 1 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 Men Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Synergetic effect of testosterone and phophodiesterase-5 inhibitors in hypogonadal men with erectile dysfunction: A systematic review. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The efficacy of combination treatment with injectable testosterone undecanoate and daily tadalafil for erectile dysfunction with testosterone deficiency syndrome. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Effects of testosterone on erectile function: implications for the therapy of erectile dysfunction. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Hypogonadal men nonresponders to the PDE5 inhibitor tadalafil benefit from normalization of testosterone levels with a 1% hydroalcoholic testosterone gel in the treatment of erectile dysfunction (TADTEST study). [2015]

5. China pubmed.ncbi.nlm.nih.gov

Do testosterone supplements enhance response to phosphodiesterase 5 inhibitors in men with erectile dysfunction and hypogonadism: a systematic review and meta-analysis. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Baseline Total Testosterone Level on Successful Treatment of Sexual Dysfunction in Men Taking Once-Daily Tadalafil 5 mg for Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia: An Integrated Analysis of Three Randomized Controlled Trials. [2018]