Pilot study to evaluate the effect of vardenafil treatment on the proteomic pattern of mononuclear cells and serum proteins in patients with erectile dysfunction and mellitus diabetes. - VAPRO

Active, not recruiting

• Conditions: Erectile Dysfuntion

• Registration Number: EUCTR2006-001002-83-ES
• Lead Sponsor: Hospital Clinico San Carlos, Unidad de Investigacion Cardiovascular

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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

- 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.

Study & Design

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