[Efficacy and tolerability of vardenafil within the time window of 6 hours after administration and beyond. Results of a clinical study carried out in 233 urological offices]

Author(s): Porst H, Lungimayr G, deutsch-osterreichische STEADY-Studiengruppe

Affiliation(s): AOKH Mistelbach, Osterreich.

Publication date & source: 2005-04-07, MMW Fortschr Med., 147 Suppl 1:27-32.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

In the multicenter STEADY-(safety, tolerability, efficacy and impact on quality of life of vardenafil 10 mg in patients with erectile dysfunction)-study, 996 patients with erectile dysfunction were treated with vardenafil for a period of 12 weeks.The results within a time window of up to 6 hours post-administration and beyond (up to 12 hours) were evaluated. The effectiveness of vardenafil was analysed on the basis of the parameters Sexual Encounter Profile (SEP) 2 (vaginal penetration) and SEP3 (erection maintenance) as also the "erectile function score" and overall satisfaction. RESULTS: On the occasion of the first follow-up 4 weeks after the administration of vardenafil there was an appreciable improvement in all four parameters. Very high success rates were observed not only during the primarily investigated time window of 6 hours, but also beyond this (up to 12 hours). Satisfaction with sexual intercourse (SI) increased from 24.6% prior to treatment to 87.6% at the end of the 12-week treatment period. CONCLUSION: Under doctor's office conditions vardenafil was reliable and highly effective, already at the 10 mg dose, when the patients utilized its effect within a time window ranging from < 0.5 to 12 hours (tablet ingestion to SI). In addition, vardenafil was very well tolerated. Patient satisfaction with the treatment was reportedly very high.