A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Phosphodiesterase 5 Inhibitors; Vardenafil Dihydrochloride

Criteria

Inclusion Criteria:

• Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance

• Heterosexual relationship for more than 6 months

• Partner willing to complete the TSS

Exclusion Criteria:

• Primary hypoactive sexual desire

• History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months

• Nitrate use

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