Status:
COMPLETED
Diabetes & Vardenafil
Lead Sponsor:
Azienda USL Modena
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Endothelial Dysfunction
Eligibility:
MALE
40-65 years
Phase:
PHASE2
Brief Summary
Given the protective effect of nitric oxide (NO) on the endothelium and the results obtained so far in short-term, continuous treatment with phosphodiesterase-5 (PDE5) inhibitors on parameters of endo...
Detailed Description
Phosphodiesterase-5 (PDE5) inhibitors are currently used in the therapy of erectile dysfunction (ED), which is considered to be an early symptom of cardiovascular disease (CD). Impairment of endotheli...
Eligibility Criteria
Inclusion
- Male gender
- Signed written Consent Form
- Type 2 diabetes mellitus diagnosed within 5 years before enrolment in the study
- Body Mass Index (BMI) \< 35
- ED (severe, moderate or light according to the International Index of Erectile Function - erectile function domain score \< 26 (Rosen et al. 1997))
- Age range: 40-65 years.
Exclusion
- Systemic diseases except type 2 diabetes mellitus
- Absence of ED
- Psychiatric disorders
- All contraindications to treatment with PDE5 inhibitors, such as retinitis pigmentosa, non-arteritic anterior ischaemic optic neuropathy, history of coronary artery disease, recent myocardial infarction, unstable angina, systemic arterial hypotension, nitric-oxide donors therapy, severe hepatic and renal failure.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02219646
Start Date
March 1 2010
End Date
February 1 2014
Last Update
August 19 2014
Active Locations (1)
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1
Unit of Endocrinology Azienda USL
Modena, Modena, Italy, 41126