Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction

Bayer0 sites333 target enrollmentMarch 2003

ConditionsErectile Dysfunction

InterventionsLevitra (Vardenafil, BAY38-9456)

DrugsLevitra (Vardenafil, BAY38-9456)

Overview

Phase: Phase 4
Intervention: Levitra (Vardenafil, BAY38-9456)
Conditions: Erectile Dysfunction
Sponsor: Bayer
Enrollment: 333
Primary Endpoint: International Index of Erectile Function - Erectile Function Domain
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

November 2003

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Bayer

Eligibility Criteria

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