vasculogenic erectile dysfunction
Conditions
Interventions
Trade Name: Viagra
Product Name: Viagra
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
National and Kapodistrial University of Athens
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (i) Patients with ED of vasculogenic origin which will be diagnosed according to comprehensive medical and sexual history (including psychiatric evaluation), physical examination, score of the five-item form of the International Index of Erectile Function, the Sexual Health Inventory for Men (SHIM score, =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (i) Diabetic patients. Diagnosis of diabetes is based on fasting glucose levels >125mg/dl (>7.0mmol/l) or use of antidiabetic treatment (ii) Left ventricular ejection fraction=40% (iii) Contraindications to sildenafil use e.g. nitrate use within 24 hours (iv) History of sildenafil intolerance (v) Primary lung disease and/or COPD (vi) Severe hepatic or renal failure (vii) Severe valvular disease (viii) Unstable arrhythmia (ix) Malignancy (x) Systemic inflammatory diseases and autoimmune diseases (xi) Corticosteroid, non-steroid anti-inflammatory drug therapy or proven anti-inflammatory regimens such as methotrexate. Any other medication will be recorded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the acute effects of sildenafil in ED patients and to estimate the time-effect of sildenafil administration in inflammatory markers in blood.;Secondary Objective: Safety and tolerance;Primary end point(s): The main outcome measures will be the changes in blood inflammatory markers at point 1 and point 2 post administration of sildenafil, which will be determined according to the results of the pilot study (it is anticipated that it will be approx 8 hours). ;Timepoint(s) of evaluation of this end point: Will be defined from the initial sub-study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome will be the time-effect of sildenafil on blood inflammatory markers. ;Timepoint(s) of evaluation of this end point: Will be defined from the initial sub-study | — |
Countries
Greece
Outcome results
None listed