Erectile Dysfunction With Diabetes MellitusPhase 3EDGENNCT06520839
Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes
A Phase 3 study testing Tadalafil 5mg in people with Erectile Dysfunction With Diabetes Mellitus, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The goal of this clinical trial is to examine the genetic markers of erectile dysfunction degree in patients with diabetes and find new predictive models based on genetic factors, with which we will be able to more accurately address the adequacy of treatment in patients with diabetes, and thus have a long-term impact… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction With Diabetes Mellitus
- What is being tested?
- Tadalafil 5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSlovenia
- Study dates
- 17 May 2024to Dec 2024
- Phase
- Phase 3
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study.
Who cannot join
- patients receiving any form of organic nitrate in regular therapy or as necessary due to ischemic heart disease, patients who have already suffered a cardiovascular event (heart attack, stroke, manifest peripheral arterial disease), users of illegal drugs, alcoholics, demented patients , patients with psychiatric diseases, patients with pancreatogenic form of diabetes, patients with glucocorticoids and immunosuppressants induced form of diabetes and patients with monogenic form of diabetes. Patients with hypogonadism, prostate malignancy, patients with a psychogenic form of erectile dysfunction, patients with premalignant and malignant genital lesions, patients with Peyronie's disease, patients after injury, surgery and radiation in the pelvic area and patients with congenital diseases of the penis will also be excluded from the research. We will also exclude from the research patients who withdraw from participation in the research during the research for personal or any other reasons.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Boštjan Hostnik, hostnikb@gmail.com
Boštjan Hostnik
About this study
The goal of this clinical trial is to examine the genetic markers of erectile dysfunction degree in patients with diabetes and find new predictive models based on genetic factors, with which we will be able to more accurately address the adequacy of treatment in patients with diabetes, and thus have a long-term impact to reduce side effects of treatment. We will look for a predictive model based on genetic analysis to determine in the future patients with a good response to treatment with phosphodiesterase type 5 inhibitors, in our case tadalafil 5 mg daily. The main questions it aims to answer are:
- Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
- Genetic alterations in the folate pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
- Genetic factors of the vascular wall influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
- Genetic changes in the pathways of tadalafil metabolism and action influence the response to the treatment of erectile dysfunction in patients with diabetes.
Participants will take the drug tadalafil 5 mg every day for three months. The level of erectile dysfunction will be assessed with the IIEF-5 questionnaire at the beginning of the study and after three months of taking the drug.
Read the detailed description
We will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study.
The research will be clinically pharmacological, prospective, interventional and genetic-associative. Patients will be selected sequentially, according to their willingness to participate in the research, taking into account the inclusion and exclusion criteria. As a result, they will not be subject to randomization. At the first examination and after signing the informed consent form for participation in the research, blood will be taken from the patients for laboratory and molecular genetic tests, they will receive the drug for the treatment of erectile dysfunction tadalafil, which they will receive in a dose of 5 mg daily for a period of three months . After three months, patients will complete the IIEF-5 questionnaire again.
At the beginning of the research, we will explain the course and purpose of the research to the people involved, they will fill out a consent form for participating in the research. Upon inclusion, we will perform the following on all subjects:
- History and clinical examination (including weight, height and body mass index). The degree of erectile dysfunction will be classified using the IIEF-5 questionnaire into four categories, namely severe (5-7 points), moderate (8-11 points), mild to moderate (12-16 points) and mild form (17-21 points ) of erectile dysfunction.
- Laboratory tests Peripheral venous blood will be taken to determine laboratory parameters: renal function, hepatogram, lipidogram, HbA1c (TIR), PSA, TSH, LH, FSH, PRL, SHBG, testosterone (total and free), folic acid.
- Molecular genetic tests 3-5 ml of peripheral venous blood will be taken from the examinees in a test tube with EDTA. Centrifugation will separate the blood plasma from the cellular part of the blood. Genomic DNA will be isolated from the cellular part of the blood using commercial reagent sets (DNA Mini Kit and Flexigene DNA kit; Qiagen, Hilden, Germany). To determine polymorphisms of individual nucleotides in the genes of the synthesis pathway, NO function and folate pathway, we will use modern high-throughput methods based on the real-time PCR reaction, such as the 5'-exonuclease test (TaqMan SNP genotyping assay; Applied Biosystems, Foster City, CA , USA) and allele-specific competitive PCR reactions (KASPar assay; KBiosciences, Herts, UK).
Candidate genes were selected based on a literature review, focusing on pathways related to the molecular pathogenesis of erectile dysfunction and pathways related to the metabolism and action of tadalafil. Based on a review of the databases (dbSNP, PharmGKB) and the literature, we searched for genetic changes in the mentioned genes that are common in the white race and affect the expression of the gene or the function of the written protein. Based on this, we decided to include the following genes and polymorphisms in the analysis:
- signaling pathway NO: NOS3: 894G/T (rs1799983), 786T/C (rs2070744)
- vascular wall factors: VEGF: 460T/C (rs833061), 1154G/A (rs1570360), 2578A/C (rs699947); ACE: rs1800764, rs4343, rs1799752; ACE2: rs2285666, rs1978124
- folate pathway: MTHFR: rs1801133 (p.Ala222Val; c. 677 C>T), rs1801131 (p.Glu429Ala; c.1298 A>C), MS: rs1805087 (p.Asp919Gly; c.2756A>G), MTRR : rs1801394 (p.Ala66Gly; 66A>G)
- tadalafil metabolism: CYP3A4*22 and CYP3A5*3
- tadalafil target: PDE5A: rs12646525, rs3806808
- Being tested
- Tadalafil 5mg
- Keywords
- Erectile Dysfunction, Diabetes Mellitus
- Medical subject headings
- Erectile Dysfunction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Also called Tadilecto 5 mg
We will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study. Each patient will receive drug tadalafil 5 mg every day for three months.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes and erectile dysfunction | Experimental | We will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study. Each patient will receive drug tadalafil 5 mg every day for three months. Receives: Drug: Tadalafil 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
Genetic polymorphisms
Measured: 3 months
Genetic variations in the folate pathway influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
Genetic polymorphisms
Measured: 3 months
Vascular wall genetic factors influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
Genetic polymorphisms
Measured: 3 months
Genetic variations in tadalafil metabolism and action pathways influence response to erectile dysfunction treatment in patients with diabetes.
Genetic polymorphisms
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start17 May 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction With Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boštjan Hostnik, University Medical Centre Ljubljana
- Investigators
- Boštjan Hostnik, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520839
- Sponsor's protocol ID
- 2024
- Acronym
- EDGEN
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT06520839
- Acronym / sponsor ID
- EDGEN / 2024
- Keywords
- Erectile Dysfunction, Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jul 2024 (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.
The goal of this clinical trial is to examine the genetic markers of erectile dysfunction degree in patients with diabetes and find new predictive models based on genetic factors, with which we will be able to more accurately address the adequacy of treatment in patients with diabetes, and thus have a long-term impact to reduce side effects of treatment. We will look for a predictive model based on genetic analysis to determine in the future patients with a good response to treatment with phosphodiesterase type 5 inhibitors, in our case tadalafil 5 mg daily. The main questions it aims to answer are:
- Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
- Genetic alterations in the folate pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
- Genetic factors of the vascular wall influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
- Genetic changes in the pathways of tadalafil metabolism and action influence the response to the treatment of erectile dysfunction in patients with diabetes.
Participants will take the drug tadalafil 5 mg every day for three months. The level of erectile dysfunction will be assessed with the IIEF-5 questionnaire at the beginning of the study and after three months of taking the drug.
Detailed description
We will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study.
The research will be clinically pharmacological, prospective, interventional and genetic-associative. Patients will be selected sequentially, according to their willingness to participate in the research, taking into account the inclusion and exclusion criteria. As a result, they will not be subject to randomization. At the first examination and after signing the informed consent form for participation in the research, blood will be taken from the patients for laboratory and molecular genetic tests, they will receive the drug for the treatment of erectile dysfunction tadalafil, which they will receive in a dose of 5 mg daily for a period of three months . After three months, patients will complete the IIEF-5 questionnaire again.
At the beginning of the research, we will explain the course and purpose of the research to the people involved, they will fill out a consent form for participating in the research. Upon inclusion, we will perform the following on all subjects:
- History and clinical examination (including weight, height and body mass index). The degree of erectile dysfunction will be classified using the IIEF-5 questionnaire into four categories, namely severe (5-7 points), moderate (8-11 points), mild to moderate (12-16 points) and mild form (17-21 points ) of erectile dysfunction.
- Laboratory tests Peripheral venous blood will be taken to determine laboratory parameters: renal function, hepatogram, lipidogram, HbA1c (TIR), PSA, TSH, LH, FSH, PRL, SHBG, testosterone (total and free), folic acid.
- Molecular genetic tests 3-5 ml of peripheral venous blood will be taken from the examinees in a test tube with EDTA. Centrifugation will separate the blood plasma from the cellular part of the blood. Genomic DNA will be isolated from the cellular part of the blood using commercial reagent sets (DNA Mini Kit and Flexigene DNA kit; Qiagen, Hilden, Germany). To determine polymorphisms of individual nucleotides in the genes of the synthesis pathway, NO function and folate pathway, we will use modern high-throughput methods based on the real-time PCR reaction, such as the 5'-exonuclease test (TaqMan SNP genotyping assay; Applied Biosystems, Foster City, CA , USA) and allele-specific competitive PCR reactions (KASPar assay; KBiosciences, Herts, UK).
Candidate genes were selected based on a literature review, focusing on pathways related to the molecular pathogenesis of erectile dysfunction and pathways related to the metabolism and action of tadalafil. Based on a review of the databases (dbSNP, PharmGKB) and the literature, we searched for genetic changes in the mentioned genes that are common in the white race and affect the expression of the gene or the function of the written protein. Based on this, we decided to include the following genes and polymorphisms in the analysis:
- signaling pathway NO: NOS3: 894G/T (rs1799983), 786T/C (rs2070744)
- vascular wall factors: VEGF: 460T/C (rs833061), 1154G/A (rs1570360), 2578A/C (rs699947); ACE: rs1800764, rs4343, rs1799752; ACE2: rs2285666, rs1978124
- folate pathway: MTHFR: rs1801133 (p.Ala222Val; c. 677 C>T), rs1801131 (p.Glu429Ala; c.1298 A>C), MS: rs1805087 (p.Asp919Gly; c.2756A>G), MTRR : rs1801394 (p.Ala66Gly; 66A>G)
- tadalafil metabolism: CYP3A4*22 and CYP3A5*3
- tadalafil target: PDE5A: rs12646525, rs3806808
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes and erectile dysfunction | Experimental | Drug: Tadalafil 5mgWe will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study. Each patient will receive drug tadalafil 5 mg every day for three months. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study.
Key exclusion criteria (1 listed)
- patients receiving any form of organic nitrate in regular therapy or as necessary due to ischemic heart disease, patients who have already suffered a cardiovascular event (heart attack, stroke, manifest peripheral arterial disease), users of illegal drugs, alcoholics, demented patients , patients with psychiatric diseases, patients with pancreatogenic form of diabetes, patients with glucocorticoids and immunosuppressants induced form of diabetes and patients with monogenic form of diabetes. Patients with hypogonadism, prostate malignancy, patients with a psychogenic form of erectile dysfunction, patients with premalignant and malignant genital lesions, patients with Peyronie's disease, patients after injury, surgery and radiation in the pelvic area and patients with congenital diseases of the penis will also be excluded from the research. We will also exclude from the research patients who withdraw from participation in the research during the research for personal or any other reasons.
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 |
|---|---|---|
| Tadalafil 5mgAlso: Tadilecto 5 mgWe will include in the study 90 patients with diabetes and erectile dysfunction. We will use the IIEF-5 questionnaire to confirm the diagnosis of erectile dysfunction. Patients between the ages of 40 and 65 who score 21 points or less on the IIEF-5 scale will be included in the study. Each patient will receive drug tadalafil 5 mg every day for three months. | Drug | Patients with diabetes and erectile dysfunction |
Primary outcome
Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
Time frame: 3 months
Genetic polymorphisms
Genetic variations in the folate pathway influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
Time frame: 3 months
Genetic polymorphisms
Vascular wall genetic factors influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
Time frame: 3 months
Genetic polymorphisms
Genetic variations in tadalafil metabolism and action pathways influence response to erectile dysfunction treatment in patients with diabetes.
Time frame: 3 months
Genetic polymorphisms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Boštjan Hostnik principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tadalafil 5mg in people with Erectile Dysfunction With Diabetes Mellitus, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. 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 Slovenia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boštjan Hostnik (+38641627240, hostnikb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes. (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2024.