A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patient With Erectile Dysfunction (VIS)
The primary objective of this study is to assess the efficacy together with safety of a flexible regimen, for a period of twelve weeks, of three doses (5 mg, 10mg and 20mg) of Bay 38-9456, a phosphodiesterase type V inhibitor, in males with erectile dysfunction treated with sildenafil in the previous <6 months .
At entry, once the Inclusion and Exclusion criteria are confirmed, the study medication will be administered for twelve weeks in an open label design. Vardenafil will be administered, as needed, at a fix dose of 10 mg once daily for the first four weeks of treatment. At the Investigators' discretion, on the basis of efficacy and safety evaluations, the patients may, then, receive the same dose strength of their assigned study medication or, at the subsequent clinic visit(s), the next lower dose (5 mg vardenafil) or the next higher dose (20 mg vardenafil) for the subsequent four weeks of treatment. Previous dose level of vardenafil is either maintained, increased or decreased by one step according to the three applicable dose strengths (5 mg, 10 mg, 20 mg ). The highest dosage of vardenafil (20 mg) per day will not be exceeded. After twelve weeks of treatment, the patient will be contacted twenty four hours following the last visit in order to collect data concerning serious adverse events.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A National, Multicentre, Open Label, Flexible Dose, Twelve Week Treatment to Assess the Efficacy and Safety of 5mg, 10mg and 20mg Bay 38-9456, a Phosphodiesterase Type V Inhibitor, in the Treatment of Male Patients With Erectile Dysfunction|
- Percentage of success rate at the end of treatment period versus baseline. [ Time Frame: At baseline, after 12 weeks ] [ Designated as safety issue: No ]
- The Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF-Appendix 10.3) calculated as the sum of scores from Questions 1-5 and 15 at Visit 5 using the last Visit vs baseline. [ Time Frame: Baseline, after 4 weeks, after 12 weeks ] [ Designated as safety issue: No ]
- Global Assessment Question [ Time Frame: Baseline, after 4 weeks, after 12 weeks ] [ Designated as safety issue: No ]
- Italian validated Version of SF-12 Health Survey [ Time Frame: Baseline, after 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Study Completion Date:||February 2004|
|Experimental: Arm 1||
Drug: Levitra (Vardenafil, BAY38-9456)
10 mg per dose of vardenafil for the first four weeks. A further 8 weeks ( in two treatment periods of four weeks, respectively) where patients will either maintain the previous dosage regimen or will step up to 20 mg per dose of vardenafil or will step down to 5 mg per dose of vardenafil, at interval visits of four weeks .