Erectile DysfunctionNCT07479901
Atherogenic Index of Plasma and Tadalafil Response in Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- tadalafil
- Type of treatment
- Pill or oral medicine
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2025to 21 Feb 2026
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men aged 40 years or older presenting consecutively to the outpatient urology clinic with erectile dysfunction symptoms for at least 3 months, an IIEF-EF score below 26, and predominantly vasculogenic erectile dysfunction based on clinical assessment were enrolled. Tadalafil 5 mg orally once daily was prescribed as part of routine clinical care, independently of study participation, and participants were prospectively followed for 12 weeks. Patients with contraindications to tadalafil, major nonvasculogenic causes of erectile dysfunction, or predefined unstable systemic or metabolic conditions were excluded.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Taksim Training and Research Hospital
Istanbul, Istanbul, 34433
About this study
Official title: Investigation of the Effect of the Atherogenic Index on the Therapeutic Response to Tadalafil in Patients With Vascular 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.
Read the detailed description
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.
- Conditions
- Erectile Dysfunction
- Being tested
- tadalafil
- Keywords
- Atherogenic Index of Plasma, Tadalafil, Treatment Response, International Index of Erectile Function, Phosphodiesterase Type 5 Inhibitor, Vasculogenic Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tadalafilDrug
Tadalafil 5 mg was prescribed orally once daily for 12 weeks as part of routine clinical care, independently of study participation.
| Study group | Role | What they receive |
|---|---|---|
| Men With Predominantly Vasculogenic Erectile Dysfunction | Men aged 40 years or older with predominantly vasculogenic erectile dysfunction who were prescribed tadalafil 5 mg orally once daily as part of routine clinical care, independently of study participation, and were prospectively followed for 12 weeks. Receives: Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Baseline Atherogenic Index of Plasma and Tadalafil Nonresponse at 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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start21 Apr 2025
- Primary completion21 Feb 2026
- Study completion21 Feb 2026
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 DysfunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taksim Egitim ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, M. B. Can Balci, Taksim Egitim ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479901
- Sponsor's protocol ID
- 29
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results reported in the primary publication will be made available upon reasonable request. These data may include baseline demographic, clinical, laboratory, lipid-profile, Atherogenic Index of Plasma (AIP), and International Index of Erectile Function-Erectile Function domain (IIEF-EF) data collected at baseline and Week 12. Direct identifiers and other information that could permit participant re-identification will not be shared.
Publications
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.
PubMed 38250336Culha 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.
PubMed 32266853
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of the Atherogenic Index on the Therapeutic Response to Tadalafil in Patients With Vascular Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT07479901
- Acronym / sponsor ID
- 29
- Conditions
- Erectile Dysfunction
- Keywords
- Atherogenic Index of Plasma, Tadalafil, Treatment Response, International Index of Erectile Function, Phosphodiesterase Type 5 Inhibitor, Vasculogenic Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Taksim Egitim ve Arastirma HastanesiOther government
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 21 Feb 2026 (actual)
- Study completion
- 21 Feb 2026 (actual)
- First posted
- 18 Mar 2026 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men With Predominantly Vasculogenic Erectile Dysfunction | – | Drug: tadalafilMen aged 40 years or older with predominantly vasculogenic erectile dysfunction who were prescribed tadalafil 5 mg orally once daily as part of routine clinical care, independently of study participation, and were prospectively followed for 12 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men aged 40 years or older presenting consecutively to the outpatient urology clinic with erectile dysfunction symptoms for at least 3 months, an IIEF-EF score below 26, and predominantly vasculogenic erectile dysfunction based on clinical assessment were enrolled. Tadalafil 5 mg orally once daily was prescribed as part of routine clinical care, independently of study participation, and participants were prospectively followed for 12 weeks. Patients with contraindications to tadalafil, major nonvasculogenic causes of erectile dysfunction, or predefined unstable systemic or metabolic conditions were excluded.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| tadalafilTadalafil 5 mg was prescribed orally once daily for 12 weeks as part of routine clinical care, independently of study participation. | Drug | Men With Predominantly Vasculogenic Erectile Dysfunction |
Primary outcome
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.
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 1 Sep 2026.
- Background: PubMed 38250336Sambel 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.
- Background: PubMed 32266853Culha 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.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results reported in the primary publication will be made available upon reasonable request. These data may include baseline demographic, clinical, laboratory, lipid-profile, Atherogenic Index of Plasma (AIP), and International Index of Erectile Function-Erectile Function domain (IIEF-EF) data collected at baseline and Week 12. Direct identifiers and other information that could permit participant re-identification will not be shared.
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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 Dysfunction, run by Taksim Egitim ve Arastirma Hastanesi 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 1 inclusion and 1 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 1 Sep 2026. 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?
Association Between Baseline Atherogenic Index of Plasma and Tadalafil Nonresponse at Week 12 (time frame: Baseline and Week 12). 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 NCT07479901, 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 1 Sep 2026.