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NCT Number: NCT07479901

Atherogenic Index of Plasma and Tadalafil Response in Erectile Dysfunction

This prospective single-center observational cohort study examined whether baseline atherogenic index of plasma (AIP), calculated from routine triglyceride and high-density lipoprotein cholesterol measurements, was associated with response to once-daily tadalafil in men aged 40 years or older with erectile dysfunction. Tadalafil 5 mg once daily was prescribed as part of routine clinical care, independently of study participation, and participants were prospectively followed for 12 weeks. Erectile function was assessed using the six-item International Index of Erectile Function-Erectile Function domain (IIEF-EF) at baseline and Week 12. Treatment response was defined as an increase of at least 4 points in the IIEF-EF score from baseline. All participants received tadalafil, and there was no untreated or placebo comparator; therefore, the study evaluated the association between baseline AIP and observed outcome during tadalafil treatment.

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Key information

Age range

40 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Taksim Training and Research Hospital

Istanbul, 34433, Turkey (Türkiye)

About this study

The atherogenic index of plasma (AIP) is a laboratory-based marker of atherogenic dyslipidemia and subclinical atherosclerosis. AIP was calculated as log10(triglycerides/high-density lipoprotein cholesterol) after conversion of both lipid values to mmol/L. Because vascular and metabolic abnormalities contribute to erectile dysfunction and may influence response to phosphodiesterase type 5 inhibitors, baseline AIP may be associated with treatment outcomes during tadalafil therapy.

This was a prospective, single-center observational cohort study of men aged 40 years or older with predominantly vasculogenic erectile dysfunction based on clinical assessment and predefined eligibility criteria. Participants were consecutively enrolled from an outpatient urology clinic. Baseline demographic, clinical, and laboratory data were recorded. Tadalafil 5 mg once daily was prescribed as part of routine clinical care, independently of study participation, and enrolled participants were prospectively followed for 12 weeks.

Erectile function was assessed using the six-item International Index of Erectile Function-Erectile Function domain (IIEF-EF) at baseline and Week 12. The primary objective was to evaluate the association between baseline AIP and tadalafil treatment response. Treatment response was defined as an increase of at least 4 points in the IIEF-EF score from baseline to Week 12; an increase of less than 4 points was classified as nonresponse.

Because all participants received tadalafil and the study did not include an untreated or placebo comparator, the association between AIP and outcome was interpreted as prognostic during tadalafil treatment rather than as evidence of causality or differential treatment benefit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men aged 40 years or older Erectile dysfunction symptoms for at least 3 months International Index of Erectile Function-Erectile Function domain (IIEF-EF) score below 26 Predominantly vasculogenic erectile dysfunction based on medical history, focused physical examination, and baseline clinical assessment Suitable for tadalafil treatment Phosphodiesterase type 5 inhibitor-naive or no phosphodiesterase type 5 inhibitor use for at least 1 month before enrollment Provided written informed consent

Exclusion criteria

Contraindication to tadalafil, including nitrate use Major cardiovascular disease within the previous 6 months or other clinically unstable cardiovascular conditions Diagnosed hypogonadism or hormone replacement therapy Severe hepatic or renal insufficiency Predominantly psychogenic erectile dysfunction Erectile dysfunction primarily attributable to neurological, hormonal, or medication-related causes Previous radical pelvic surgery or major pelvic trauma Penile anatomical abnormalities, including Peyronie's disease Alcohol or substance dependence Poorly controlled diabetes mellitus, defined as glycated hemoglobin (HbA1c) of 8.0% or higher Use of medications affecting lipid metabolism, such as corticosteroids Initiation or dose modification of lipid-lowering therapy within the previous 3 months Uncontrolled thyroid dysfunction Active infection or inflammatory disease Active malignancy treatment

Treatment and study plan

Tadalafil

Drug

Tadalafil 5 mg was prescribed orally once daily for 12 weeks as part of routine clinical care, independently of study participation.

Primary outcomes

  1. Association Between Baseline Atherogenic Index of Plasma and Tadalafil Nonresponse at Week 12

    Time frame: Baseline and Week 12

    Baseline atherogenic index of plasma (AIP) was calculated as log10(triglycerides/high-density lipoprotein cholesterol) after conversion of both values to mmol/L. Erectile function was assessed using the six-item International Index of Erectile Function-Erectile Function domain (IIEF-EF) at baseline and Week 12. Treatment response was defined as an increase of at least 4 points in the IIEF-EF score from baseline to Week 12, and nonresponse was defined as an increase of less than 4 points. The association between baseline AIP and tadalafil nonresponse at Week 12 was evaluated.

Sponsors and collaborators

Lead sponsor

Taksim Egitim ve Arastirma Hastanesi

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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