Erectile DysfunctionsNCT07274982
The Predictive Value of Modified EASIX Score for Determining Erectile Dysfunction Severity
An observational study of Erectile Dysfunctions and Endothelial Dysfunction, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunctions, Endothelial Dysfunction, Inflammation
- What is being tested?
- IIEF-5 and mEASIX
- How many people
- 380 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 28 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of Modified EASIX Score in Determining Severity of Erectile Dysfunction - A Single-Center Retrospective Case-Control Study
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.
- Conditions
- Erectile Dysfunctions, Endothelial Dysfunction, Inflammation
- Being tested
- IIEF-5, mEASIX
- Keywords
- Erectile Dysfunctions, EASIX, modified EASIX, IIEF-5, endothelial inflammation
- Medical subject headings
- Erectile Dysfunction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IIEF-5Other
IIEF-5: The erectile dysfunction status of patients will be analyzed with the International Index of Erectile Function-5.
mEASIXOther
Endothelial function will be evaluated with mEAX.
| Study group | Role | What they receive |
|---|---|---|
| Erectile Dysfunction Group | Erectile Dysfunction Group Receives: Other: IIEF-5; Other: mEASIX | |
| Non-Erectile Dysfunction Group | Non-Erectile Dysfunction Group Receives: Other: IIEF-5; Other: mEASIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective records from Jan 1, 2024 to Sep 30, 2025.
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.
Measured: Time Frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 May 2025
- Primary completion15 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Turkey
- Responsible party
- Principal investigator, okkes zortuk, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274982
- Sponsor's protocol ID
- ZTKLAB03112025KUGOEK2520UROLGY
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 35887519Pennisi 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Modified EASIX Score in Determining Severity of Erectile Dysfunction - A Single-Center Retrospective Case-Control Study
- ClinicalTrials.gov ID
- NCT07274982
- Acronym / sponsor ID
- ZTKLAB03112025KUGOEK2520UROLGY
- Conditions
- Erectile Dysfunctions, Endothelial Dysfunction, Inflammation
- Keywords
- Erectile Dysfunctions, EASIX, modified EASIX, IIEF-5, endothelial inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, Turkey
- Study start
- 1 May 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erectile Dysfunction Group | – | Other: IIEF-5, Other: mEASIXErectile Dysfunction Group |
| Non-Erectile Dysfunction Group | – | Other: IIEF-5, Other: mEASIXNon-Erectile Dysfunction Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IIEF-5IIEF-5: The erectile dysfunction status of patients will be analyzed with the International Index of Erectile Function-5. | Other | Erectile Dysfunction Group, Non-Erectile Dysfunction Group |
| mEASIXEndothelial function will be evaluated with mEAX. | Other | Erectile Dysfunction Group, Non-Erectile Dysfunction Group |
Primary outcome
Difference in Modified EASIX score between ED and non-ED groups
Time frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.
Mean Modified EASIX (LDH × CRP / Platelets) in each group. Group comparison (t-test) and effect size.
Difference in Modified EASIX score between ED and non-ED groups
Time frame: Time Frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.
Median Modified EASIX (LDH × CRP / Platelets) in each group. Group comparison (Mann-Whitney U) and effect size.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 35887519Zinczuk 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.
- Results publication: PubMed 34432870Pennisi 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunctions and Endothelial Dysfunction, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Modified EASIX score between ED and non-ED groups (time frame: Retrospective records from Jan 1, 2024 to Sep 30, 2025.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07274982, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.