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

NCT06520839 | Recruiting Phase 3

• 1 other identifier: 2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Genetic alterations in the folate pathway affect the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
3. 3.Genetic factors of the vascular wall influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.
4. 4.Genetic changes in the pathways of tadalafil metabolism and action influence the response to the treatment of erectile dysfunction in patients with diabetes.

Conditions

Erectile Dysfunction With Diabetes Mellitus

Keywords

Erectile Dysfunction; Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• 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

  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

  3 months

• Vascular wall genetic factors influence the degree of erectile dysfunction and the response to tadalafil treatment in patients with diabetes.

  Genetic polymorphisms

  3 months

• Genetic variations in tadalafil metabolism and action pathways influence response to erectile dysfunction treatment in patients with diabetes.

  Genetic polymorphisms

  3 months

Study Arms (1)

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.

Drug: Tadalafil 5mg

Interventions

Tadalafil 5mg DRUG

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.

Also known as: Tadilecto 5 mg

Patients with diabetes and erectile dysfunction

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Boštjan Hostnik

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boštjan Hostnik

CONTACT

+38641627240; hostnikb@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, internal medicine physician

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 25, 2024
• Study Start: May 17, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)