Examining genetic factors affecting erectile dysfunction treatment in diabetic patients
Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes
This study is testing how genetic differences affect the treatment of erectile dysfunction in men with diabetes to see if it can help personalize their care with tadalafil.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Male |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT06520839 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the genetic markers associated with the severity of erectile dysfunction in patients with diabetes. It aims to develop predictive models based on genetic analysis to better tailor tadalafil treatment for these patients. The study will include 90 participants aged 40 to 65 who have been diagnosed with erectile dysfunction using the IIEF-5 questionnaire. Participants will receive tadalafil 5 mg daily for three months, after which their erectile function will be reassessed. The research is designed to identify how genetic variations influence treatment response and erectile dysfunction severity.
Who should consider this trial
Good fit: Ideal candidates are men aged 40 to 65 with diabetes who have erectile dysfunction as confirmed by the IIEF-5 questionnaire.
Not a fit: Patients with certain cardiovascular conditions, psychiatric disorders, or specific forms of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for erectile dysfunction in diabetic patients.
How similar studies have performed: While there have been studies on erectile dysfunction and diabetes, this specific genetic approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Ljubljana
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: Boštjan Hostnik — University Medical Centre Ljubljana
- Study coordinator: Boštjan Hostnik
- Email: hostnikb@gmail.com
- Phone: +38641627240
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.