Overview
Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse
Status:
Completed
Completed
Trial end date:
2004-12-01
2004-12-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
BayerCollaborator:
GlaxoSmithKlineTreatments:
Vardenafil Dihydrochloride
Criteria
Inclusion Criteria:- Men >/= 18 years of age
- ED >/= 6 months
- Stable sexual relationship for > 6 months
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