NCT07479901

Investigation of the Effect of the Atherogenic Index on the Therapeutic Response to Tadalafil in Patients With Vascular Erectile Dysfunction

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 132 (estimated)
• Sponsor: Taksim Egitim ve Arastirma Hastanesi · Other Government
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the relationship between the atherogenic index of plasma (AIP) and the therapeutic response to daily tadalafil 5 mg treatment in patients diagnosed with vascular erectile dysfunction (VED). AIP is considered a marker of atherogenic dyslipidemia and subclinical atherosclerosis and is calculated using the formula log10 (triglycerides/HDL-C). Since vascular abnormalities play a major role in the pathophysiology of erectile dysfunction, AIP may reflect underlying vascular risk and potentially predict treatment outcomes. In this prospective observational study, patients with vascular erectile dysfunction will receive tadalafil 5 mg once daily for one month, and treatment response will be evaluated by comparing clinical parameters before and after therapy.

Detailed description

The Atherogenic Index of Plasma (AIP) has been widely accepted as an indicator of atherogenic dyslipidemia and subclinical atherosclerosis. It is a simple laboratory-based parameter calculated using the formula log10 (triglycerides/HDL-C) and has been associated with increased cardiovascular risk. Vascular erectile dysfunction (VED) represents one of the most important organic causes of erectile dysfunction and results from vascular abnormalities that impair adequate penile blood flow. Tadalafil 5 mg administered once daily is an established treatment option for patients with vascular erectile dysfunction. However, the variability in treatment response suggests that underlying vascular risk factors may influence therapeutic outcomes. Identifying predictive biomarkers that can estimate treatment response may improve patient selection and treatment strategies. The primary objective of this study is to evaluate whether AIP levels are associated with the response to tadalafil treatment in patients with vascular erectile dysfunction. The study also aims to assess the relationship between lipid profile parameters and the severity of erectile dysfunction, as well as to identify potential predictors of treatment response. This study is designed as a prospective observational study. Participants diagnosed with vascular erectile dysfunction will receive tadalafil 5 mg once daily for a period of one month. Clinical and laboratory evaluations will be performed before and after treatment. The findings of this study are expected to determine whether AIP can serve as a potential biomarker for predicting the therapeutic response to tadalafil in patients with vascular erectile dysfunction.

Conditions

• Erectile Dysfunction Vascular Erectile Dysfunction Atherogenic Dyslipidemia

Timeline

• Start date: 2025-10-12
• Primary completion: 2026-03-21
• Completion: 2026-04-20
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Turkey (Türkiye)