Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia
Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
Summary
This study is being conducted in US to obtain information on the efficacy, safety, and
duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy
medication with no pharmacological activity), in patients with co-morbid factors associated
with erectile dysfunction (also called impotence). The duration of erection endpoint will be
assessed by patient utilized stopwatch timings during each attempt at sexual intercourse.
Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and
induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug
Administration for the treatment of erectile dysfunction. While there is no intent to assess
the effect vardenafil has on blood lipids, the study will provide prospective data on men
diagnosed with both ED and dyslipidemia.