Monitoring of endothelial dysfunction during chronic administration of vardenafil in patients with type 2 diabetes mellitus: A longitudinal, randomised, placebo-controlled, double blind, phase II b, clinical trial - VARDENAFIL&DIABETES

Conditions: patients affected by type 2 Diabetes mellitus and affected by mild or severe ED
MedDRA version: 12.0Level: LLTClassification code 10045248Term: Type II diabetes mellitus with other specified manifestations

Registration Number: EUCTR2009-014137-25-IT

Lead Sponsor: nita` Operativa di Endocrinologia e Malattie del Metabolismo

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

- Male gender; - Signed written Consent Form - Type 2 diabetes mellitus diagnosed within 12 months 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: 40-60 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Systemic diseases except type 2 diabetes mellitus; - Absence of ED; - Psychiatric disorders; - All contraindications to treatment with PDE5 inhibitors

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to monitor the endothelial dysfunction during continuous treatment with vardenafil for 6 months; object of the study will be endothelin 1 and other known parameters of endothelial damage in newly diagnosed patients with type 2 diabetes mellitus;Secondary Objective: nd;Primary end point(s): The primary end point is the serum endothelin 1 concentration (decreased/not increased in the verum group vs. not decrease/increased in the placebo group).

Secondary Outcome Measures