drugset / Trial / NCT00379756

A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia

NCT00379756

Phase 4 Completed 395 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.

Timeline

Start
2006-05-22
Primary completion
2007-05-17
Completion
2007-05-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Vardenafil Small molecule 10 mg
Comparator Vardenafil Small molecule 20 mg

Indications