drugset / Trial / NCT00379756
A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vardenafil | Small molecule | 10 mg | — |
| Comparator | Vardenafil | Small molecule | 20 mg | — |