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CompletedNCT07274982Updated Dec 10, 2025

The Predictive Value of Modified EASIX Score for Determining Erectile Dysfunction Severity

An observational study in Erectile Dysfunctions, Endothelial Dysfunction and Inflammation, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Ataturk University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
380
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

This retrospective single-center case-control study evaluates whether the Modified EASIX score (LDH × CRP / Platelets), calculated from routine blood tests, predicts severity of erectile dysfunction (ED) as measured by the IIEF-5 questionnaire. Medical records from January 1, 2024 to September 30, 2025 will be reviewed. Patients will be classified by IIEF-5 (≤21 = ED; ≥22 = no ED) and Modified EASIX distributions and predictive performance (ROC/AUC) will be compared between groups. No additional interventions will be performed.

Read the detailed description

This retrospective observational study will include adult male patients aged 18-65 attending the urology outpatient clinic. Demographic data, comorbidities, IIEF-5 scores and routine laboratory results (LDH, CRP, platelet count and other routine biochemistry/hematology) obtained during routine follow-up will be extracted from medical records covering January 2024-September 2025. The Modified EASIX score will be computed as: LDH × CRP / Platelets. Patients will be grouped according to IIEF-5: ED group (IIEF-5 ≤21) and non-ED group (IIEF-5 ≥22). Primary analyses include group comparisons of Modified EASIX, correlation analyses with IIEF-5, logistic regression for association and ROC analysis to evaluate discriminatory performance and optimal cut-offs. Analyses will use IBM SPSS 27 and GraphPad Prism 9. No changes to patient management were made for study purposes; no additional sampling or interventions were performed.

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Conditions studied

  • Erectile Dysfunctions
  • Endothelial Dysfunction
  • Inflammation

Keywords

  • Erectile Dysfunctions
  • EASIX
  • modified EASIX
  • IIEF-5
  • endothelial inflammation
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In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 380 is above the median of 130 across 115 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult male patients aged 18-65 who attended the urology outpatient clinic and had documented IIEF-5 scores and routine laboratory results (LDH, CRP, platelet count) between January 2024 and September 2025. The study includes both patients with erectile dysfunction (IIEF-5 ≤ 21) and those without erectile dysfunction (IIEF-5 ≥ 22), using retrospectively collected medical records from a single center (Defne State Hospital).

Inclusion criteria

Male patients aged 18-65. Followed at the urology outpatient clinic with a documented IIEF-5 questionnaire.

Available routine laboratory data including LDH, CRP and platelet count within the study period (Jan 1, 2024 - Sep 30, 2025).

Exclusion criteria

Exclusion Criteria:

Use of penile prosthesis. Patients without an organic ED diagnosis when relevant (per protocol: "Patients without an organic ED diagnosis will be excluded from the study").

Missing essential data for Modified EASIX calculation or IIEF-5.

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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
380 participants (actual)
Patient registry
No

Groups and cohorts

  • Erectile Dysfunction Group

    Erectile Dysfunction Group

    Other: IIEF-5 · Other: mEASIX

  • Non-Erectile Dysfunction Group

    Non-Erectile Dysfunction Group

    Other: IIEF-5 · Other: mEASIX

Interventions

  • OtherIIEF-5

    IIEF-5: The erectile dysfunction status of patients will be analyzed with the International Index of Erectile Function-5.

  • OthermEASIX

    Endothelial function will be evaluated with mEAX.

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What researchers measure

Primary outcomes

  1. Difference in Modified EASIX score between ED and non-ED groups

    Mean Modified EASIX (LDH × CRP / Platelets) in each group. Group comparison (t-test) and effect size.

    Time frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.

  2. Difference in Modified EASIX score between ED and non-ED groups

    Median Modified EASIX (LDH × CRP / Platelets) in each group. Group comparison (Mann-Whitney U) and effect size.

    Time frame: Time Frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.

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Study locations

1 site
  • Defne State Hospital
    Hatay, Defne 31000, Turkey (Türkiye)
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References and documents

Publications

  • Zinczuk A, Rorat M, Simon K, Jurek T. EASIX, Modified EASIX and Simplified EASIX as an Early Predictor for Intensive Care Unit Admission and Mortality in Severe COVID-19 Patients. J Pers Med. 2022 Jun 21;12(7):1022. doi: 10.3390/jpm12071022. PubMed 35887519 ↗
  • Pennisi M, Sanchez-Escamilla M, Flynn JR, Shouval R, Alarcon Tomas A, Silverberg ML, Batlevi C, Brentjens RJ, Dahi PB, Devlin SM, Diamonte C, Giralt S, Halton EF, Jain T, Maloy M, Mead E, Palomba ML, Ruiz J, Santomasso B, Sauter CS, Scordo M, Shah GL, Park JH, Yanez San Segundo L, Perales MA. Modified EASIX predicts severe cytokine release syndrome and neurotoxicity after chimeric antigen receptor T cells. Blood Adv. 2021 Sep 14;5(17):3397-3406. doi: 10.1182/bloodadvances.2020003885. PubMed 34432870 ↗

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be publicly shared because the study is based on retrospective medical records containing sensitive personal health information. Due to privacy concerns and institutional data-protection regulations, de-identified datasets cannot be released outside the research team.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07274982
Lead sponsor
Ataturk University
Collaborators
Ministry of Health, Turkey
Responsible party
okkes zortuk (Principal Investigator, Ataturk University) — Principal investigator
First posted
Dec 10, 2025
Start date
May 1, 2025
Primary completion
Nov 15, 2025
Completion
Nov 28, 2025
Last update
Dec 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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