ot applicable

• Conditions: vasculogenic erectile dysfunction; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2011-005333-39-GR
• Lead Sponsor: ational and Kapodistrial University of Athens

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-21
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 31

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, <21 indicating ED), hormonal testing (total testosterone and prolactin) and penile Doppler ultrasonography. Vasculogenic ED will be diagnosed when the peak systolic velocity is less than 35 cm/s, and/or when the end-diastolic velocity is greater than 5 cm/s. Through these evaluations, patients will be excluded if their ED was secondary to hormonal, psychological, neurological, or anatomic abnormalities, pelvic surgery, or trauma
(ii) Age 30-70 years old
(iii) Clinically stable with no apparent ischemic disease. Evaluation of the subjects in order to rule out significant coronary artery disease will include a complete medical history and examination, measurements of blood pressure and heart rate, standard laboratory tests, a 12-lead electrocardiogram and an exercise test
(iv) Willing to provide informed consent

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) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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