Trial Condition(s):

Erectile Dysfunction

Evaluation of the safety and efficacy of Vardenafil in subjects with Erectile Dysfunction

Bayer Identifier:

100541

ClinicalTrials.gov Identifier:

NCT00681772

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.

Inclusion Criteria
- Men >/= 18 years of age,
 - ED 6 months or longer
 - Stable sexual relationship for > 6 month.
Exclusion Criteria
- Primary hypoactive sexual desire
 - 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

Trial Summary

Enrollment Goal
333
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Australia

Status
Completed
 

Trial Design