The effects of acute sildenafil administration on inflammatory markers in patients with vasculogenic erectile dysfunction. - Not applicable

ational and Kapodistrial University of Athens0 个研究点目标入组 31 人开始时间: 2011年11月21日最近更新: 2014年2月10日

试验速览

暂无简介。

•(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

•(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.

发起方

ational and Kapodistrial University of Athens