Erectile Dysfuntion
Conditions
Interventions
Trade Name: Levitra
Product Name: LEVITRA
Pharmaceutical Form: Tablet
INN or Proposed INN: hidroclorur vardenafil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20
Sponsors
Hospital Clinico San Carlos, Unidad de Investigacion Cardiovascular
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Men who have had erectile disfuntion for at least six months according to the national Institutes of health NIH consensus Conference of 7-9 December, 1992. - Patients with stable or moderate DE that they don't requiere to change his treatment during development study. - Patients who receives vardenafil for the treatment of his DE. - Patient from 18 to 64 years old of age. - Written informed consent obtained. 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
Exclusion criteria: - Any unstable medical, psychiatric or subatance abuse disordes that in the investigator’s opinion is likely to affect the patient’s ability to complete the study or precludes the patient’s participation in the study. - Presence of penile anatomical abnormalities. - History of surgical prostatectomy. - History of surgical to medule lession. - Retinitis pigmentosa. - Unstable angina pectoris. - Moderate to severe hepatic impairment (Child-Pugh B or C) - Class III and IV cardiac impairment (NYHA). - Positive patients to test of surface antigen of HBV or HCV. - Patients with chronic hematologic disorder like falciform anemia. - Hemorrhagic disorders. - Patients who are iliterate or unable to understand the questionnaires or who are not prepare to complete the patient diary. - And those of the technical information of product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the different proteomic pattern obtained of plasma and mononuclear cells from patients with erectile dysfuntion and diabetes mellitus, after the treatment with vardenafil 20 mg for 12 weeks.;Secondary Objective: ;Primary end point(s): Study proteic pattern of proteome of patients with DE and DM | — |
Countries
Spain
Outcome results
None listed