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

December 15, 2014 updated by: Bayer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

732

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3G 3J9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 5J3
    • New Brunswick
      • St. John, New Brunswick, Canada, E2L 3J8
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 4K9
    • Ontario
      • Barrie, Ontario, Canada, L4M 4S5
      • Toronto, Ontario, Canada, M4C 3E7
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Sherbrooke, Quebec, Canada, J1H 5N4
  • France
      • Carpentras, France, 84200
      • Lille, France, 59000
      • Lyon, France, 69000
      • Lyon Cedex, France, 69437
      • Marseille, France, 13275
      • Montpellier, France, 34000
      • Nimes, France, 30000
      • Paris, France, 75015
  • Germany
      • Hamburg, Germany, 20354
    • Bayern
      • Garmisch-Partenkirchen, Bayern, Germany, 82467
      • München, Bayern, Germany, 80333
      • München, Bayern, Germany, 81925
    • Hessen
      • Marburg, Hessen, Germany, 35039
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
      • Osnabrück, Niedersachsen, Germany, 49076
      • Westerstede, Niedersachsen, Germany, 26655
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40210
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
      • Niederkassel, Nordrhein-Westfalen, Germany, 53859
    • Sachsen
      • Leipzig, Sachsen, Germany, 04105
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06097
  • Italy
      • Milano, Italy, 20132
      • Milano, Italy, 20142
      • Modena, Italy, 41100
      • Napoli, Italy, 80131
      • Padova, Italy, 35128
  • Netherlands
      • Amsterdam, Netherlands, 1061 AE
      • Den Haag, Netherlands, 2512 VA
      • Nijmegen, Netherlands, 6525 GA
      • Roermond, Netherlands, 6043 CV
      • Utrecht, Netherlands, 3514 AB
  • Norway
      • Moelv, Norway, 2390
      • Oslo, Norway, 0272
      • Sarpsborg, Norway, 1700
      • Trondheim, Norway, 7006
  • Poland
      • Koscierzyna, Poland, 83-400
      • Lodz, Poland, 91-425
      • Poznan, Poland, 61-701
      • Warszawa, Poland, 04-749
      • Warszawa, Poland, 01-059
      • Wroclaw, Poland, 54-144
  • Spain
      • Barcelona, Spain, 08003
      • Castellón de la Plana, Spain, 12004
      • Madrid, Spain, 28040
      • Zaragoza, Spain, 50009
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Bizkaia
      • Galdakao, Bizkaia, Spain, 48960
    • Cataluña
      • Barcelona, Cataluña, Spain, 08025
  • Sweden
      • Borås, Sweden, 503 32
      • Göteborg, Sweden, 412 59
      • Skövde, Sweden, 541 30
      • Stockholm, Sweden, 171 76
  • United Kingdom
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8HW
      • Bristol, Avon, United Kingdom, BS10 5NB
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
    • California
      • Beverly Hills, California, United States, 90212
      • San Bernardino, California, United States, 92404
    • Colorado
      • Aurora, Colorado, United States, 80012
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
    • Florida
      • Aventura, Florida, United States, 33180
      • Jacksonville, Florida, United States, 32257
      • Pembroke Pines, Florida, United States, 33024
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
    • New York
      • New York, New York, United States, 10016
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
      • Wilmington, North Carolina, United States, 28401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg and 20 mg orally once a day as needed
Placebo Comparator: Arm 2
Drug: Placebo
Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- 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)
Time Frame: First four doses with successful intercourse
First four doses with successful intercourse

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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).
Time Frame: among the first four doses
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.
Time Frame: among the first four doses
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.
Time Frame: among the first four doses
among the first four doses
- Other diary questions
Time Frame: among the first four doses
among the first four doses
- Safety and tolerability
Time Frame: within the study duration
within the study duration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Study Completion (Actual)

November 1, 2003

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 24, 2008

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100492 (Other Identifier: UCSD Human Subjects Protection Program)
  • ONTIME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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