Overview

Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
0
Participant gender:
Male
Summary
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Collaborator:
GlaxoSmithKline
Treatments:
Vardenafil Dihydrochloride
Criteria
Inclusion Criteria:

- Men >/= 18 years of age

- Erectile Dysfunction

Exclusion Criteria:

- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6
month

- Nitrate therapy

- Other exclusion criteria apply according to the Summary of Product Characteristics