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

NCT07479901 | Active Not Recruiting

• 1 other identifier: Taksim Eğitim Araştırma
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction Vascular Erectile Dysfunction Atherogenic Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Association Between Atherogenic Index of Plasma and Response to Tadalafil Treatment

  Assessment of the relationship between the baseline Atherogenic Index of Plasma (AIP) and the therapeutic response to daily tadalafil 5 mg treatment in patients with vascular erectile dysfunction. Treatment response will be evaluated by the change in erectile function scores measured using the International Index of Erectile Function (IIEF-5) before and after one month of therapy.

  1 Month

Study Arms (1)

Patients With Vascular Erectile Dysfunction

Patients diagnosed with vascular erectile dysfunction receiving tadalafil 5 mg once daily.

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of men older than 40 years who have been diagnosed with vascular erectile dysfunction and are considered suitable candidates for tadalafil therapy. Participants must have experienced symptoms of erectile dysfunction for at least three months. Eligible patients will receive tadalafil 5 mg once daily for a period of at least four weeks. Patients with significant comorbid conditions, contraindications to tadalafil therapy, or other causes of erectile dysfunction will be excluded according to the predefined exclusion criteria.

You may not qualify if:

• Uncontrolled cardiac arrhythmias
• Hypotension
• Diagnosis of hypogonadism
• History of major cardiovascular events within the last 6 months (including uncontrolled hypertension or severe ischemic heart disease)
• Severe hepatic or renal insufficiency
• Patients receiving hormone replacement therapy
• Patients diagnosed with psychogenic, neurological, hormonal, or pharmacological erectile dysfunction
• History of radical pelvic surgery
• Anatomical abnormalities of the penis
• History of non-arteritic anterior ischemic optic neuropathy (NAION)
• Retinitis pigmentosa
• Known hypersensitivity to tadalafil or other phosphodiesterase type-5 inhibitors
• Alcohol or substance abuse
• Use of other treatments for erectile dysfunction
• Unstable diabetes mellitus

Sponsors & Collaborators

• Taksim Egitim ve Arastirma Hastanesi: lead

Study Sites (1)

Taksim Training and Research Hospital, Istanbul

Istanbul, beyoğlu, 34433, Turkey (Türkiye)

Location

Related Publications (2)

• Sambel M, Erdogan A, Caglayan V, Avci S, Kilic S, Yildiz HE, Keskin E. Can atherogenic indices and the triglyceride-glucose index be used to predict erectile dysfunction? Sex Med. 2024 Jan 19;11(6):qfad069. doi: 10.1093/sexmed/qfad069. eCollection 2023 Dec.

  PMID: 38250336 RESULT

• Culha MG, Canat L, Degirmentepe RB, Albayrak AT, Atalay HA, Merder E, Ariman A, Altunrende F. The correlation between atherogenic indexes and erectile dysfunction. Aging Male. 2020 Dec;23(5):1232-1236. doi: 10.1080/13685538.2020.1749996. Epub 2020 Apr 8.

  PMID: 32266853 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: October 12, 2025
• Primary Completion: March 21, 2026
• Study Completion: April 20, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)