NCT00379756

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

Completed Phase 4 Last updated 16 August 2017

What this trial tests

Phase 4 trial testing LEVITRA (vardenafil) in Erectile Dysfunction in 395 participants. Completed in 17 May 2007.

Timeline

22 May 2006

Primary endpoint
17 May 2007

17 May 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	395
Start date	22 May 2006
Primary completion	17 May 2007
Estimated completion	17 May 2007
Sites	65 locations across United States

Drugs / interventions tested

• LEVITRA (vardenafil) — full drug profile →
• placebo

Conditions studied

• Erectile Dysfunction — all drugs for Erectile Dysfunction →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 64, male only, with Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.