Trial Condition(s):

Erectile Dysfunction

Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in subjects with erectile dysfunction

Bayer Identifier:

10898

ClinicalTrials.gov Identifier:

NCT00656188

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Inclusion Criteria
- Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, 
- History of unresponsiveness to sildenafil
- 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

Trial Summary

Enrollment Goal
463
Trial Dates
black-arrow
Phase
2/3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design