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NCT07479901
Investigation of the Effect of the Atherogenic Index on the Therapeutic Response to Tadalafil in Patients With Vascular Erectile Dysfunction
Conditions: Erectile Dysfunction Vascular Erectile Dysfunction Atherogenic Dyslipidemia
Sex: Male
Ages: 40 Years – N/A
Healthy volunteers: No
Enrollment: 132
Sponsor: Taksim Egitim ve Arastirma Hastanesi
Location: Taksim Training and Research Hospital, Istanbul Istanbul Beyoğlu
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.
Eligibility Criteria
Inclusion Criteria:Men older than 40 years of age who have been diagnosed with vascular erectile dysfunction, have had symptoms for at least three months, have been considered suitable for tadalafil treatment, and have received tadalafil therapy for at least four weeks.
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Exclusion Criteria:Use of nitrates
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
History of medications affecting lipid profile (such as corticosteroids or certain antidepressants)
Initiation or dose modification of lipid-lowering therapy (e.g., statins, fibrates) within the last 3 months
Uncontrolled thyroid dysfunction
Active infection or inflammatory conditions
Patients receiving active cancer treatment
Inability to comply with study procedures
Beck Depression Inventory score greater than 0
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Source: ClinicalTrials.gov (NCT07479901). StuddyBuddy aggregates publicly available trial information.