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Genetic Factors of Erectile Dysfunction Degree and Response to Tadalafil Treatment in Patients With Diabetes

NCT06520839 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-07-25

No results posted yet for this study

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 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

  • Erectile Dysfunction With Diabetes Mellitus

Interventions

DRUG

Tadalafil 5mg

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.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Boštjan Hostnik · University Medical Centre Ljubljana

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-17
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06520839 on ClinicalTrials.gov