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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Urologisk senter Oslo, Norway, 0272 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Toronto East General Hospital Toronto, Canada, M4C 3E7 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Fundació Puigvert Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska University Hospital Stockholm, Sweden, 171 76 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL MO Hesperia Hospital Modena, Italy, 41100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Olav Hospital HF Trondheim, Norway, 7006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Miedzyleski Szpital Specjalistyczny Warszawa, Poland, 04-749 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ED-Kliniken Skövde, Sweden, 541 30 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Florida Medical Research Aventura, United States, 33180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Centrum Haaglanden, Locatie Westeinde DEN HAAG, Netherlands, 2512 VA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologisk kirurgisk poliklinikk Sarpsborg, Norway, 1700 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Specjalistyczny Koscierzyna, Poland, 83-400 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologmottagningen Läkargruppen Borås, Sweden, 503 32 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lawrenceville Urology Lawrenceville, United States, 08648 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Marlowe Jason, MD Winnipeg, Canada, R3T 5J3 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Male/Female Health & Research Centre Barrie, Canada, L4M 4S5 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H. Porst Hamburg, Germany, 20354 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Galdakao Galdakao, Spain, 48960 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Carrémeau - Nimes NIMES, France, 30000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bristol Royal Infirmary Bristol, United Kingdom, BS2 8HW | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione San Raffaele Milano, Italy, 20132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersytet Medyczny Lodz, Poland, 91-425 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Specialistmottagningen i Urologi och Andrologi Göteborg, Sweden, 412 59 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations San Bernardino Urological Associates San Bernardino, United States, 92404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Martin-Luther-Universität Halle-Wittenberg Halle, Germany, 06097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - Gambetta - Lyon LYON, France, 69000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southmead Hospital Bristol, United Kingdom, BS10 5NB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Federico II Napoli, Italy, 80131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitair Medisch Centrum St. Radboud NIJMEGEN, Netherlands, 6525 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moelv Spesialistsenter Moelv, Norway, 2390 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Miguel Servet Zaragoza, Spain, 50009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Crowfoot Village Family Practice Calgary, Canada, T3G 3J9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital del Mar Barcelona, Spain, 08003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Lucas Andreas Ziekenhuis, Lokatie St. Lucas AMSTERDAM, Netherlands, 1061 AE | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital EuroMediCare Wroclaw, Poland, 54-144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jacksonville Impotence Treatment Center Jacksonville, United States, 32257 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Universitaire de Sante de l'Estrie Sherbrooke, Canada, J1H 5N4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. W. te Breuil Düsseldorf, Germany, 40210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital General de Castelló Castellón de la Plana, Spain, 12004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cabinet Médical - 178 Vaugirard - Paris PARIS, France, 75015 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Male Clinic Beverly Hills, United States, 90212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Metrolina Medical Research Associates Charlotte, United States, 28209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. von Keitz Marburg, Germany, 35039 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Clinical Research, Inc. Pembroke Pines, United States, 33024 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A.-J. Potempa München, Germany, 80333 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Diagnostyki Medycznej Multi Med Warszawa, Poland, 01-059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Consultants, Inc. Trumbull, United States, 06611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Bruce W. Palmer, MD Kentville, Canada, B4N 4K9 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Osnabrück GmbH Osnabrück, Germany, 49076 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Synergia - Carpentras CARPENTRAS, France, 84200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Novella Research en Advies UTRECHT, Netherlands, 3514 AB | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coburg Street Medical Clinic St. John, Canada, E2L 3J8 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Padova Padova, Italy, 35128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ammerland-Klinik GmbH Westerstede, Germany, 26655 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Sainte Marguerite - Marseille MARSEILLE, France, 13275 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Paolo Polo Universitario Milano, Italy, 20142 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Laurentius Ziekenhuis ROERMOND, Netherlands, 6043 CV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Akademia Medyczna Poznan, Poland, 61-701 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. D. Potempa Garmisch-Partenkirchen, Germany, 82467 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology Research Options Aurora, United States, 80012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. S. Szymula Leipzig, Germany, 04105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CETPARP - Carolus - Lille LILLE, France, 59000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Research Center, Inc. Phoenix, United States, 85023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Maisonneuve-Rosemont Montreal, Canada, H1T 2M4 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ev. Krankenhaus "Bethesda" Mönchengladbach gGmbH Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maison de la Mutualité - Montpellier MONTPELLIER, France, 34000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. M. Göbel Niederkassel, Germany, 53859 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. W. Grohmann München, Germany, 81925 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Havover Medical Research Associates Wilmington, United States, 28401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Urology Associates New York, United States, 10016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double blind, double dummy, parallel group, multi-center 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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- - Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)Timeframe: First four doses with successful intercourse
Secondary Outcome
- - Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2).Timeframe: among the first four doses
- - The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores.Timeframe: among the first four doses
- - Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.Timeframe: among the first four doses
- - Other diary questionsTimeframe: among the first four doses
- - Safety and tolerabilityTimeframe: within the study duration
Additional Information
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