Trial Condition(s):

Erectile Dysfunction

A study to investigate the time to onset of action of 10 mg and 20 mg of Vardenafil compared to Placebo in males with erectile Dysfunction

Bayer Identifier:

100492

ClinicalTrials.gov Identifier:

NCT00665496

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

Inclusion Criteria
- Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
 - Heterosexual relationship
 - 18 years and older
Exclusion Criteria
- Primary hypoactive sexual desire
 - History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
 - Nitrates or nitric oxide donors use
 - Other exclusion criteria according to the US Product Information

Trial Summary

Enrollment Goal
732
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Urologisk senter

Oslo, Norway, 0272

Status
Completed
 
Locations

Toronto East General Hospital

Toronto, Canada, M4C 3E7

Status
Completed
 
Locations

Hospital Fundació Puigvert

Barcelona, Spain, 08025

Status
Terminated
 
Locations

Karolinska University Hospital

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

AUSL MO Hesperia Hospital

Modena, Italy, 41100

Status
Terminated
 
Locations

St Olav Hospital HF

Trondheim, Norway, 7006

Status
Completed
 
Locations

Miedzyleski Szpital Specjalistyczny

Warszawa, Poland, 04-749

Status
Completed
 
Locations

ED-Kliniken

Skövde, Sweden, 541 30

Status
Completed
 
Locations

South Florida Medical Research

Aventura, United States, 33180

Status
Completed
 
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Completed
 
Locations

Medisch Centrum Haaglanden, Locatie Westeinde

DEN HAAG, Netherlands, 2512 VA

Status
Completed
 
Locations

Urologisk kirurgisk poliklinikk

Sarpsborg, Norway, 1700

Status
Completed
 
Locations

Szpital Specjalistyczny

Koscierzyna, Poland, 83-400

Status
Completed
 
Locations

Urologmottagningen Läkargruppen

Borås, Sweden, 503 32

Status
Completed
 
Locations

Lawrenceville Urology

Lawrenceville, United States, 08648

Status
Completed
 
Locations

Office of Dr. Marlowe Jason, MD

Winnipeg, Canada, R3T 5J3

Status
Completed
 
Locations

Male/Female Health & Research Centre

Barrie, Canada, L4M 4S5

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. H. Porst

Hamburg, Germany, 20354

Status
Completed
 
Locations

Hospital de Galdakao

Galdakao, Spain, 48960

Status
Terminated
 
Locations

Hopital Carrémeau - Nimes

NIMES, France, 30000

Status
Completed
 
Locations

Bristol Royal Infirmary

Bristol, United Kingdom, BS2 8HW

Status
Completed
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

Status
Completed
 
Locations

Uniwersytet Medyczny

Lodz, Poland, 91-425

Status
Completed
 
Locations

Specialistmottagningen i Urologi och Andrologi

Göteborg, Sweden, 412 59

Status
Completed
 
Locations

San Bernardino Urological Associates

San Bernardino, United States, 92404

Status
Completed
 
Locations

Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06097

Status
Completed
 
Locations

Cabinet Médical - Gambetta - Lyon

LYON, France, 69000

Status
Completed
 
Locations

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Status
Completed
 
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Terminated
 
Locations

Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

Status
Terminated
 
Locations

Moelv Spesialistsenter

Moelv, Norway, 2390

Status
Completed
 
Locations

Hospital Miguel Servet

Zaragoza, Spain, 50009

Status
Completed
 
Locations

Crowfoot Village Family Practice

Calgary, Canada, T3G 3J9

Status
Terminated
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Terminated
 
Locations

St. Lucas Andreas Ziekenhuis, Lokatie St. Lucas

AMSTERDAM, Netherlands, 1061 AE

Status
Completed
 
Locations

Szpital EuroMediCare

Wroclaw, Poland, 54-144

Status
Terminated
 
Locations

Jacksonville Impotence Treatment Center

Jacksonville, United States, 32257

Status
Completed
 
Locations

Centre Universitaire de Sante de l'Estrie

Sherbrooke, Canada, J1H 5N4

Status
Completed
 
Locations

Praxis Hr. Dr. W. te Breuil

Düsseldorf, Germany, 40210

Status
Completed
 
Locations

Hospital General de Castelló

Castellón de la Plana, Spain, 12004

Status
Completed
 
Locations

Cabinet Médical - 178 Vaugirard - Paris

PARIS, France, 75015

Status
Terminated
 
Locations

The Male Clinic

Beverly Hills, United States, 90212

Status
Completed
 
Locations

Metrolina Medical Research Associates

Charlotte, United States, 28209

Status
Completed
 
Locations

Praxis Hr. Dr. A. von Keitz

Marburg, Germany, 35039

Status
Completed
 
Locations

University Clinical Research, Inc.

Pembroke Pines, United States, 33024

Status
Completed
 
Locations

Praxis Hr. Dr. A.-J. Potempa

München, Germany, 80333

Status
Completed
 
Locations

Centrum Diagnostyki Medycznej Multi Med

Warszawa, Poland, 01-059

Status
Completed
 
Locations

Clinical Research Consultants, Inc.

Trumbull, United States, 06611

Status
Completed
 
Locations

Office of Dr. Bruce W. Palmer, MD

Kentville, Canada, B4N 4K9

Status
Completed
 
Locations

Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Synergia - Carpentras

CARPENTRAS, France, 84200

Status
Completed
 
Locations

Novella Research en Advies

UTRECHT, Netherlands, 3514 AB

Status
Completed
 
Locations

Coburg Street Medical Clinic

St. John, Canada, E2L 3J8

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hôpital Edouard Herriot - Lyon Cedex

LYON CEDEX, France, 69437

Status
Completed
 
Locations

A.O. di Padova

Padova, Italy, 35128

Status
Completed
 
Locations

Ammerland-Klinik GmbH

Westerstede, Germany, 26655

Status
Completed
 
Locations

Hôpital Sainte Marguerite - Marseille

MARSEILLE, France, 13275

Status
Completed
 
Locations

A.O. San Paolo Polo Universitario

Milano, Italy, 20142

Status
Completed
 
Locations

St. Laurentius Ziekenhuis

ROERMOND, Netherlands, 6043 CV

Status
Completed
 
Locations

Akademia Medyczna

Poznan, Poland, 61-701

Status
Completed
 
Locations

Praxis Hr. Dr. D. Potempa

Garmisch-Partenkirchen, Germany, 82467

Status
Terminated
 
Locations

Urology Research Options

Aurora, United States, 80012

Status
Completed
 
Locations

Praxis Dr. S. Szymula

Leipzig, Germany, 04105

Status
Completed
 
Locations

CETPARP - Carolus - Lille

LILLE, France, 59000

Status
Completed
 
Locations

Arizona Research Center, Inc.

Phoenix, United States, 85023

Status
Completed
 
Locations

Hopital Maisonneuve-Rosemont

Montreal, Canada, H1T 2M4

Status
Completed
 
Locations

Ev. Krankenhaus "Bethesda" Mönchengladbach gGmbH

Mönchengladbach, Germany, 41061

Status
Completed
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Terminated
 
Locations

Maison de la Mutualité - Montpellier

MONTPELLIER, France, 34000

Status
Terminated
 
Locations

Praxis Hr. Dr. M. Göbel

Niederkassel, Germany, 53859

Status
Completed
 
Locations

Praxis Hr. Dr. W. Grohmann

München, Germany, 81925

Status
Completed
 
Locations

New Havover Medical Research Associates

Wilmington, United States, 28401

Status
Completed
 
Locations

University Urology Associates

New York, United States, 10016

Status
Completed
 

Trial Design