check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100492

ClinicalTrials.gov Identifier:

NCT00665496

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - 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
  • - 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
June 2003 - November 2003
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Urologisk senterOslo, 0272, Norway
Completed
Toronto East General HospitalToronto, M4C 3E7, Canada
Terminated
Hospital Fundació PuigvertBarcelona, 08025, Spain
Completed
Karolinska University HospitalStockholm, 171 76, Sweden
Terminated
AUSL MO Hesperia HospitalModena, 41100, Italy
Completed
St Olav Hospital HFTrondheim, 7006, Norway
Completed
Miedzyleski Szpital SpecjalistycznyWarszawa, 04-749, Poland
Completed
ED-KlinikenSkövde, 541 30, Sweden
Completed
South Florida Medical ResearchAventura, 33180, United States
Completed
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Medisch Centrum Haaglanden, Locatie WesteindeDEN HAAG, 2512 VA, Netherlands
Completed
Urologisk kirurgisk poliklinikkSarpsborg, 1700, Norway
Completed
Szpital SpecjalistycznyKoscierzyna, 83-400, Poland
Completed
Urologmottagningen LäkargruppenBorås, 503 32, Sweden
Completed
Lawrenceville UrologyLawrenceville, 08648, United States
Completed
Office of Dr. Marlowe Jason, MDWinnipeg, R3T 5J3, Canada
Completed
Male/Female Health & Research CentreBarrie, L4M 4S5, Canada
Completed
Praxis Hr. Prof. Dr. H. PorstHamburg, 20354, Germany
Terminated
Hospital de GaldakaoGaldakao, 48960, Spain
Completed
Hopital Carrémeau - NimesNIMES, 30000, France
Completed
Bristol Royal InfirmaryBristol, BS2 8HW, United Kingdom
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
Universitair Medisch Centrum St. RadboudNIJMEGEN, 6525 GA, Netherlands
Completed
Uniwersytet MedycznyLodz, 91-425, Poland
Completed
Specialistmottagningen i Urologi och AndrologiGöteborg, 412 59, Sweden
Completed
San Bernardino Urological AssociatesSan Bernardino, 92404, United States
Completed
Martin-Luther-Universität Halle-WittenbergHalle, 06097, Germany
Completed
Cabinet Médical - Gambetta - LyonLYON, 69000, France
Completed
Southmead HospitalBristol, BS10 5NB, United Kingdom
Terminated
A.O.U. Federico IINapoli, 80131, Italy
Terminated
Universitair Medisch Centrum St. RadboudNIJMEGEN, 6525 GA, Netherlands
Completed
Moelv SpesialistsenterMoelv, 2390, Norway
Completed
Hospital Miguel ServetZaragoza, 50009, Spain
Terminated
Crowfoot Village Family PracticeCalgary, T3G 3J9, Canada
Terminated
Hospital del MarBarcelona, 08003, Spain
Completed
St. Lucas Andreas Ziekenhuis, Lokatie St. LucasAMSTERDAM, 1061 AE, Netherlands
Terminated
Szpital EuroMediCareWroclaw, 54-144, Poland
Completed
Jacksonville Impotence Treatment CenterJacksonville, 32257, United States
Completed
Centre Universitaire de Sante de l'EstrieSherbrooke, J1H 5N4, Canada
Completed
Praxis Hr. Dr. W. te BreuilDüsseldorf, 40210, Germany
Completed
Hospital General de CastellóCastellón de la Plana, 12004, Spain
Terminated
Cabinet Médical - 178 Vaugirard - ParisPARIS, 75015, France
Completed
The Male ClinicBeverly Hills, 90212, United States
Completed
Metrolina Medical Research AssociatesCharlotte, 28209, United States
Completed
Praxis Hr. Dr. A. von KeitzMarburg, 35039, Germany
Completed
University Clinical Research, Inc.Pembroke Pines, 33024, United States
Completed
Praxis Hr. Dr. A.-J. PotempaMünchen, 80333, Germany
Completed
Centrum Diagnostyki Medycznej Multi MedWarszawa, 01-059, Poland
Completed
Clinical Research Consultants, Inc.Trumbull, 06611, United States
Completed
Office of Dr. Bruce W. Palmer, MDKentville, B4N 4K9, Canada
Completed
Klinikum Osnabrück GmbHOsnabrück, 49076, Germany
Completed
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Synergia - CarpentrasCARPENTRAS, 84200, France
Completed
Novella Research en AdviesUTRECHT, 3514 AB, Netherlands
Completed
Coburg Street Medical ClinicSt. John, E2L 3J8, Canada
Completed
Ciutat Sanitària i Universitària de BellvitgeL'Hospitalet de Llobregat, 08907, Spain
Completed
Hôpital Edouard Herriot - Lyon CedexLYON CEDEX, 69437, France
Completed
A.O. di PadovaPadova, 35128, Italy
Completed
Ammerland-Klinik GmbHWesterstede, 26655, Germany
Completed
Hôpital Sainte Marguerite - MarseilleMARSEILLE, 13275, France
Completed
A.O. San Paolo Polo UniversitarioMilano, 20142, Italy
Completed
St. Laurentius ZiekenhuisROERMOND, 6043 CV, Netherlands
Completed
Akademia MedycznaPoznan, 61-701, Poland
Terminated
Praxis Hr. Dr. D. PotempaGarmisch-Partenkirchen, 82467, Germany
Completed
Urology Research OptionsAurora, 80012, United States
Completed
Praxis Dr. S. SzymulaLeipzig, 04105, Germany
Completed
CETPARP - Carolus - LilleLILLE, 59000, France
Completed
Arizona Research Center, Inc.Phoenix, 85023, United States
Completed
Hopital Maisonneuve-RosemontMontreal, H1T 2M4, Canada
Completed
Ev. Krankenhaus "Bethesda" Mönchengladbach gGmbHMönchengladbach, 41061, Germany
Terminated
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Terminated
Maison de la Mutualité - MontpellierMONTPELLIER, 34000, France
Completed
Praxis Hr. Dr. M. GöbelNiederkassel, 53859, Germany
Completed
Praxis Hr. Dr. W. GrohmannMünchen, 81925, Germany
Completed
New Havover Medical Research AssociatesWilmington, 28401, United States
Completed
University Urology AssociatesNew York, 10016, United States

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)
    date_rangeTime Frame:
    First four doses with successful intercourse
    enhanced_encryption
    Safety Issue:
    no

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).
    date_rangeTime Frame:
    among the first four doses
    enhanced_encryption
    Safety Issue:
    no
  • - 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.
    date_rangeTime Frame:
    among the first four doses
    enhanced_encryption
    Safety Issue:
    no
  • - Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.
    date_rangeTime Frame:
    among the first four doses
    enhanced_encryption
    Safety Issue:
    no
  • - Other diary questions
    date_rangeTime Frame:
    among the first four doses
    enhanced_encryption
    Safety Issue:
    no
  • - Safety and tolerability
    date_rangeTime Frame:
    within the study duration
    enhanced_encryption
    Safety Issue:
    yes

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

Additional Information

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