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

EU CT 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
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Urologisk senter

Oslo, Norway, 0272

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Toronto East General Hospital

Toronto, Canada, M4C 3E7

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Hospital Fundació Puigvert

Barcelona, Spain, 08025

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Karolinska University Hospital

Stockholm, Sweden, 171 76

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AUSL MO Hesperia Hospital

Modena, Italy, 41100

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St Olav Hospital HF

Trondheim, Norway, 7006

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Miedzyleski Szpital Specjalistyczny

Warszawa, Poland, 04-749

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ED-Kliniken

Skövde, Sweden, 541 30

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South Florida Medical Research

Aventura, United States, 33180

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Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

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Medisch Centrum Haaglanden, Locatie Westeinde

DEN HAAG, Netherlands, 2512 VA

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Urologisk kirurgisk poliklinikk

Sarpsborg, Norway, 1700

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Szpital Specjalistyczny

Koscierzyna, Poland, 83-400

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Urologmottagningen Läkargruppen

Borås, Sweden, 503 32

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Lawrenceville Urology

Lawrenceville, United States, 08648

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Office of Dr. Marlowe Jason, MD

Winnipeg, Canada, R3T 5J3

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Male/Female Health & Research Centre

Barrie, Canada, L4M 4S5

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Praxis Hr. Prof. Dr. H. Porst

Hamburg, Germany, 20354

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Hospital de Galdakao

Galdakao, Spain, 48960

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Hopital Carrémeau - Nimes

NIMES, France, 30000

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Bristol Royal Infirmary

Bristol, United Kingdom, BS2 8HW

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IRCCS Fondazione San Raffaele

Milano, Italy, 20132

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Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

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Uniwersytet Medyczny

Lodz, Poland, 91-425

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Specialistmottagningen i Urologi och Andrologi

Göteborg, Sweden, 412 59

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San Bernardino Urological Associates

San Bernardino, United States, 92404

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Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06097

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Cabinet Médical - Gambetta - Lyon

LYON, France, 69000

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Southmead Hospital

Bristol, United Kingdom, BS10 5NB

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A.O.U. Federico II

Napoli, Italy, 80131

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Universitair Medisch Centrum St. Radboud

NIJMEGEN, Netherlands, 6525 GA

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Moelv Spesialistsenter

Moelv, Norway, 2390

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Hospital Miguel Servet

Zaragoza, Spain, 50009

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Crowfoot Village Family Practice

Calgary, Canada, T3G 3J9

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Hospital del Mar

Barcelona, Spain, 08003

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St. Lucas Andreas Ziekenhuis, Lokatie St. Lucas

AMSTERDAM, Netherlands, 1061 AE

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Szpital EuroMediCare

Wroclaw, Poland, 54-144

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Jacksonville Impotence Treatment Center

Jacksonville, United States, 32257

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Centre Universitaire de Sante de l'Estrie

Sherbrooke, Canada, J1H 5N4

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Praxis Hr. Dr. W. te Breuil

Düsseldorf, Germany, 40210

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Hospital General de Castelló

Castellón de la Plana, Spain, 12004

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Cabinet Médical - 178 Vaugirard - Paris

PARIS, France, 75015

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The Male Clinic

Beverly Hills, United States, 90212

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Metrolina Medical Research Associates

Charlotte, United States, 28209

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Praxis Hr. Dr. A. von Keitz

Marburg, Germany, 35039

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University Clinical Research, Inc.

Pembroke Pines, United States, 33024

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Praxis Hr. Dr. A.-J. Potempa

München, Germany, 80333

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Centrum Diagnostyki Medycznej Multi Med

Warszawa, Poland, 01-059

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Clinical Research Consultants, Inc.

Trumbull, United States, 06611

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Office of Dr. Bruce W. Palmer, MD

Kentville, Canada, B4N 4K9

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Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

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Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

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Synergia - Carpentras

CARPENTRAS, France, 84200

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Novella Research en Advies

UTRECHT, Netherlands, 3514 AB

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Coburg Street Medical Clinic

St. John, Canada, E2L 3J8

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Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

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Hôpital Edouard Herriot - Lyon Cedex

LYON CEDEX, France, 69437

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A.O. di Padova

Padova, Italy, 35128

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Ammerland-Klinik GmbH

Westerstede, Germany, 26655

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Hôpital Sainte Marguerite - Marseille

MARSEILLE, France, 13275

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A.O. San Paolo Polo Universitario

Milano, Italy, 20142

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St. Laurentius Ziekenhuis

ROERMOND, Netherlands, 6043 CV

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Akademia Medyczna

Poznan, Poland, 61-701

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Praxis Hr. Dr. D. Potempa

Garmisch-Partenkirchen, Germany, 82467

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Urology Research Options

Aurora, United States, 80012

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Praxis Dr. S. Szymula

Leipzig, Germany, 04105

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CETPARP - Carolus - Lille

LILLE, France, 59000

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Arizona Research Center, Inc.

Phoenix, United States, 85023

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Hopital Maisonneuve-Rosemont

Montreal, Canada, H1T 2M4

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Ev. Krankenhaus "Bethesda" Mönchengladbach gGmbH

Mönchengladbach, Germany, 41061

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Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

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Maison de la Mutualité - Montpellier

MONTPELLIER, France, 34000

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Praxis Hr. Dr. M. Göbel

Niederkassel, Germany, 53859

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Praxis Hr. Dr. W. Grohmann

München, Germany, 81925

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New Havover Medical Research Associates

Wilmington, United States, 28401

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University Urology Associates

New York, United States, 10016

Trial Design