PDE5 Inhibitor + Testosterone Therapy for Erectile Dysfunction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates treatments for erectile dysfunction (ED) related to poor blood flow and low testosterone levels (hypogonadism). Researchers aim to assess how two treatments—daily low-dose PDE5 inhibitors (a medication that improves blood flow) and testosterone therapy—affect blood vessel health. Participants will undergo tests before and after treatment to evaluate changes in blood vessel function. This trial may suit men diagnosed with erectile dysfunction or low testosterone levels. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that low-dose PDE5 inhibitors are well-tolerated by many users. These medications, commonly used to treat erectile dysfunction (ED), have a history of safety and are FDA-approved for ED. They are generally considered safe when used as directed.
Research has shown that testosterone therapy, often used for men with low testosterone levels, is also well-tolerated. Studies indicate it can improve sexual function and quality of life without major side effects on heart health or metabolism. Although some heart-related issues have been reported, the risk remains low and similar to those not receiving the therapy.
Both treatments in this trial have demonstrated safety in other settings, making them promising options for participants.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they bring a fresh approach to tackling erectile dysfunction (ED). Unlike standard treatments that typically involve PDE5 inhibitors like Viagra, this study explores a daily low-dose regimen combined with testosterone therapy. The low-dose PDE5 therapy aims to improve endothelial function over time, potentially offering benefits with fewer side effects. Additionally, testosterone therapy addresses hormonal deficiencies in hypogonadal men, which could enhance the overall effectiveness of ED treatment by targeting both vascular and hormonal aspects of the condition. This dual approach could offer a more comprehensive solution for men with vasculogenic ED.
What evidence suggests that this trial's treatments could be effective for erectile dysfunction?
Research has shown that certain medications, known as PDE5 inhibitors, effectively treat erectile dysfunction (ED) by increasing blood flow to the penis, facilitating erections. Studies have found these drugs are usually well-tolerated and significantly enhance erectile function. In this trial, one group of participants will receive daily low-dose PDE5 inhibitor therapy.
For testosterone therapy, research indicates it improves sexual function in men with low testosterone levels, a condition called hypogonadism. It can alleviate symptoms like low sex drive and erectile dysfunction. Another group in this trial will receive testosterone therapy according to clinical guidelines. Although combining testosterone therapy with PDE5 inhibitors may enhance treatment effectiveness for some men with ED, this combination is not being tested in this trial.13467Who Is on the Research Team?
Faysal Yafi, MD
Principal Investigator
University of California, Irvine
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily low-dose PDE5 inhibitor therapy or testosterone therapy, with endothelial function assessed using the EndoPAT device
Follow-up
Participants are monitored for safety and effectiveness after treatment, including cardiovascular health markers and sexual function scores
What Are the Treatments Tested in This Trial?
Interventions
- Daily low-dose PDE5 inhibitor therapy
- Testosterone therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor