Actively Recruiting
Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes
Led by University Medical Centre Ljubljana · Updated on 2024-07-25
90
Participants Needed
1
Research Sites
28 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: 1. Genetic alterations in the NO signaling pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes. 2. Genetic alterations in the folate pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes. 3. Genetic factors of the vascular wall influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes. 4. 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.
CONDITIONS
Official Title
Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with diabetes and erectile dysfunction confirmed by the IIEF-5 questionnaire
- Age between 40 and 65 years
- IIEF-5 score of 21 points or less
You will not qualify if you...
- Use of organic nitrates regularly or as needed for ischemic heart disease
- History of cardiovascular events such as heart attack, stroke, or peripheral arterial disease
- Use of illegal drugs or alcohol abuse
- Dementia or psychiatric diseases
- Pancreatogenic, glucocorticoid/immunosuppressant-induced, or monogenic forms of diabetes
- Hypogonadism or prostate cancer
- Psychogenic erectile dysfunction
- Premalignant or malignant genital lesions
- Peyronie's disease
- Pelvic injury, surgery, or radiation history
- Congenital penile diseases
- Withdrawal from the study during participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
B
Boštjan Hostnik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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