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Not yet recruiting NCT06962462

Daily Tadalafil in Diabetic ED Patients

No phase Interventional Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methyl Cellulose Placebo.
Who it may be relevant to
Registry conditions: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus. Basic parameters: 30 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Daily Tadalafil Therapy on Endothelin-1 and E-Selectin in Diabetic Patients With Erectile Dysfunction

Overview

This study evaluates the effect of 5 mg daily tadalafil therapy on serum levels of Endothelin-1 and E-selectin in diabetic male patients with erectile dysfunction. Outcomes will be compared pre- and post-treatment versus healthy controls.

Interventions

  • Drug Methyl Cellulose Placebo
    Oral administration of inert methyl cellulose placebo tablets once daily for 3 months. Used as a comparator in healthy control participants to evaluate changes in Endothelin-1 and E-selectin serum levels.

Primary outcome measures

  • Effect of tadalafil 5 mg on serum levels of Endothelin-1 and E-selectin [Time frame: 3 months after intervention]
Secondary outcome measures (1)
  • Biochemical assessment of serum Endothelin-1 and E-selectin levels [Time frame: 3 months after intervention]

Eligibility criteria

Inclusion criteria

Male patients aged between 30 and 60 yearsز Diagnosed with diabetes mellitus Suffering from erectile dysfunction No history of hypertension or other systemic diseases

Exclusion criteria

History of pelvic trauma or major pelvic surgery Pacientes con hipogonadismo o hiperprolactinemia Chronic liver disease or cardiovascular disorders Chronic use of central nervous system drugs, anti-androgenic drugs, or Tramadol Smokers Non-vasculogenic erectile dysfunction Known allergy to tadalafil

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06962462 · DR-AKA-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗