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Completed Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT00379756

Public ClinicalTrials.gov record NCT00379756. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 8:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00379756
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
395 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 64 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 22, 2006 (Actual)
Primary completion
May 17, 2007 (Actual)
Completion
May 17, 2007 (Actual)
Last update posted
Aug 16, 2017

2006 – 2007

United States locations

U.S. sites
65
U.S. states
28
U.S. cities
64
Facility City State ZIP Site status
GSK Investigational Site Fairhope Alabama 36532 —
GSK Investigational Site Homewood Alabama 35209 —
GSK Investigational Site Huntsville Alabama 35801 —
GSK Investigational Site Phoenix Arizona 85016 —
GSK Investigational Site Phoenix Arizona 85023 —
GSK Investigational Site Concord California 94520 —
GSK Investigational Site Huntington Park California 90255 —
GSK Investigational Site Long Beach California 90806 —
GSK Investigational Site Modesto California 95350 —
GSK Investigational Site Newport Beach California 92660 —
GSK Investigational Site Orangevale California 95662 —
GSK Investigational Site Santa Ana California 92705 —
GSK Investigational Site Walnut Creek California 94598 —
GSK Investigational Site Denver Colorado 80210 —
GSK Investigational Site Wheat Ridge Colorado 80033 —
GSK Investigational Site New Britain Connecticut 06052 —
GSK Investigational Site Aventura Florida 33180 —
GSK Investigational Site Clearwater Florida 33761 —
GSK Investigational Site Coral Gables Florida 33134 —
GSK Investigational Site Fort Myers Florida 33916 —
GSK Investigational Site North Miami Florida 33161 —
GSK Investigational Site Orlando Florida 32803 —
GSK Investigational Site Pembroke Pines Florida 33024 —
GSK Investigational Site Pinecrest Florida 33156 —
GSK Investigational Site Sarasota Florida 34237 —
GSK Investigational Site South Miami Florida 33143 —
GSK Investigational Site St. Petersburg Florida 33710 —
GSK Investigational Site Tampa Florida 33607 —
GSK Investigational Site West Palm Beach Florida 33401 —
GSK Investigational Site Atlanta Georgia 30342 —
GSK Investigational Site Columbus Georgia 31904 —
GSK Investigational Site Dawsonville Georgia 30534 —
GSK Investigational Site Roswell Georgia 30076 —
GSK Investigational Site Woodstock Georgia 30189 —
GSK Investigational Site Avon Indiana 46123 —
GSK Investigational Site Evansville Indiana 47714 —
GSK Investigational Site Fort Wayne Indiana 46825 —
GSK Investigational Site Jeffersonville Indiana 47130 —
GSK Investigational Site Wichita Kansas 67207 —
GSK Investigational Site Lexington Kentucky 40509 —
GSK Investigational Site Madisonville Kentucky 42431 —
GSK Investigational Site Shreveport Louisiana 71106 —
GSK Investigational Site Swansea Maine 02777 —
GSK Investigational Site Taunton Massachusetts 02780 —
GSK Investigational Site Kalamazoo Michigan 49009 —
GSK Investigational Site Saint Louis Park Minnesota 55416 —
GSK Investigational Site St Louis Missouri 63117 —
GSK Investigational Site Omaha Nebraska 68134 —
GSK Investigational Site Las Vegas Nevada 89119 —
GSK Investigational Site Lawrenceville New Jersey 08648 —
GSK Investigational Site New York New York 10016 —
GSK Investigational Site Rochester New York 14609 —
GSK Investigational Site West Seneca New York 14224 —
GSK Investigational Site Charlotte North Carolina 28262 —
GSK Investigational Site Fayetteville North Carolina 28304 —
GSK Investigational Site Winston-Salem North Carolina 27103 —
GSK Investigational Site Shippensburg Pennsylvania 17257 —
GSK Investigational Site Nashville Tennessee 37203 —
GSK Investigational Site Amarillo Texas 79106 —
GSK Investigational Site Salt Lake City Utah 84107 —
GSK Investigational Site Norfolk Virginia 23502 —
GSK Investigational Site Richmond Virginia 23294 —
GSK Investigational Site Seattle Washington 98166 —
GSK Investigational Site Menomonee Falls Wisconsin 53051 —
GSK Investigational Site Milwaukee Wisconsin 53209 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00379756, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 16, 2017 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00379756 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →