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

Last updated: December 15, 2014
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Erectile Dysfunction

Infertility

Impotence

Treatment

N/A

Clinical Study ID

NCT00665496
100492
ONTIME
  • Ages > 18
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males with ED for more than 6 months according to the NIH Consensusstatement(inability to attain and/or maintain penile erection sufficient forsatisfactory sexual performance)

  • Heterosexual relationship

  • 18 years and older

Exclusion

Exclusion Criteria:

  • Primary hypoactive sexual desire

  • History of myocardial infarction, stroke or life threatening arrhythmia within theprior 6 months

  • Nitrates or nitric oxide donors use

  • Other exclusion criteria according to the US Product Information

Study Design

Total Participants: 732
Study Start date:
June 01, 2003
Estimated Completion Date:
November 30, 2003

Connect with a study center

  • Calgary, Alberta T3G 3J9
    Canada

    Site Not Available

  • Winnipeg, Manitoba R3T 5J3
    Canada

    Site Not Available

  • St. John, New Brunswick E2L 3J8
    Canada

    Site Not Available

  • Kentville, Nova Scotia B4N 4K9
    Canada

    Site Not Available

  • Barrie, Ontario L4M 4S5
    Canada

    Site Not Available

  • Toronto, Ontario M4C 3E7
    Canada

    Site Not Available

  • Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Carpentras, 84200
    France

    Site Not Available

  • Lille, 59000
    France

    Site Not Available

  • Lyon, 69000
    France

    Site Not Available

  • Lyon Cedex, 69437
    France

    Site Not Available

  • Marseille, 13275
    France

    Site Not Available

  • Montpellier, 34000
    France

    Site Not Available

  • Nimes, 30000
    France

    Site Not Available

  • Paris, 75015
    France

    Site Not Available

  • Garmisch-Partenkirchen, Bayern 82467
    Germany

    Site Not Available

  • empty

    München, Bayern 80333
    Germany

    Site Not Available

  • München, Bayern 80333
    Germany

    Site Not Available

  • Marburg, Hessen 35039
    Germany

    Site Not Available

  • Hannover, Niedersachsen 30625
    Germany

    Site Not Available

  • empty

    Osnabrück, Niedersachsen 49076
    Germany

    Site Not Available

  • Osnabrück, Niedersachsen 49076
    Germany

    Site Not Available

  • Westerstede, Niedersachsen 26655
    Germany

    Site Not Available

  • empty

    Düsseldorf, Nordrhein-Westfalen 40210
    Germany

    Site Not Available

  • Düsseldorf, Nordrhein-Westfalen 40210
    Germany

    Site Not Available

  • empty

    Mönchengladbach, Nordrhein-Westfalen 41061
    Germany

    Site Not Available

  • Mönchengladbach, Nordrhein-Westfalen 41061
    Germany

    Site Not Available

  • Niederkassel, Nordrhein-Westfalen 53859
    Germany

    Site Not Available

  • Leipzig, Sachsen 04105
    Germany

    Site Not Available

  • Halle, Sachsen-Anhalt 06097
    Germany

    Site Not Available

  • Hamburg, 20354
    Germany

    Site Not Available

  • Milano, 20132
    Italy

    Site Not Available

  • Modena, 41100
    Italy

    Site Not Available

  • Napoli, 80131
    Italy

    Site Not Available

  • Padova, 35128
    Italy

    Site Not Available

  • Amsterdam, 1061 AE
    Netherlands

    Site Not Available

  • Den Haag, 2512 VA
    Netherlands

    Site Not Available

  • Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Roermond, 6043 CV
    Netherlands

    Site Not Available

  • Utrecht, 3514 AB
    Netherlands

    Site Not Available

  • Moelv, 2390
    Norway

    Site Not Available

  • Oslo, 0272
    Norway

    Site Not Available

  • Sarpsborg, 1700
    Norway

    Site Not Available

  • Trondheim, 7006
    Norway

    Site Not Available

  • Koscierzyna, 83-400
    Poland

    Site Not Available

  • Lodz, 91-425
    Poland

    Site Not Available

  • Poznan, 61-701
    Poland

    Site Not Available

  • Warszawa, 04-749
    Poland

    Site Not Available

  • Wroclaw, 54-144
    Poland

    Site Not Available

  • Badalona, Barcelona 08916
    Spain

    Site Not Available

  • L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Galdakao, Bizkaia 48960
    Spain

    Site Not Available

  • Barcelona, Cataluña 08025
    Spain

    Site Not Available

  • empty

    Castellón de la Plana, 12004
    Spain

    Site Not Available

  • Castellón de la Plana, 12004
    Spain

    Site Not Available

  • Madrid, 28040
    Spain

    Site Not Available

  • Zaragoza, 50009
    Spain

    Site Not Available

  • empty

    Borås, 503 32
    Sweden

    Site Not Available

  • Borås, 503 32
    Sweden

    Site Not Available

  • empty

    Göteborg, 412 59
    Sweden

    Site Not Available

  • Göteborg, 412 59
    Sweden

    Site Not Available

  • empty

    Skövde, 541 30
    Sweden

    Site Not Available

  • Skövde, 541 30
    Sweden

    Site Not Available

  • Stockholm, 171 76
    Sweden

    Site Not Available

  • Bristol, Avon BS10 5NB
    United Kingdom

    Site Not Available

  • Phoenix, Arizona 85023
    United States

    Site Not Available

  • Beverly Hills, California 90212
    United States

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  • San Bernardino, California 92404
    United States

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  • Aurora, Colorado 80012
    United States

    Site Not Available

  • Trumbull, Connecticut 06611
    United States

    Site Not Available

  • Aventura, Florida 33180
    United States

    Site Not Available

  • Jacksonville, Florida 32257
    United States

    Site Not Available

  • Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Lawrenceville, New Jersey 08648
    United States

    Site Not Available

  • New York, New York 10016
    United States

    Site Not Available

  • Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Wilmington, North Carolina 28401
    United States

    Site Not Available

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