Daily Tadalafil in Diabetic ED Patients
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 →
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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