check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11875

ClinicalTrials.gov Identifier:

NCT00786253

EudraCT Number:

Not Available

EU CT Number:

Not Available
Sustainable efficacy of vardenafil OD versus vardenafil PRN in erectile dysfunction

Trial purpose

Compare once daily vs on demand treatment in men with erectile dysfunction.

Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:

A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - Males 18-64 years of age
    - Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
    - History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
    - Stable, heterosexual relationship for more than six months
  • - Primary hypoactive sexual desire
    - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
    - Nitrate therapy.

Trial summary

Enrollment Goal
236
Trial Dates
October 2005 - January 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Completed
Martin-Luther-Universität Halle-WittenbergHalle, 06097, Germany
Completed
Kliniken der Medizinischen Hochschule HannoverHannover, 30625, Germany
Completed
Klinikum Osnabrück GmbHOsnabrück, 49076, Germany
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Klinikum WeidenWeiden, 92637, Germany
Completed
Praxis Hr. Dr. W. GrohmannMünchen, 81925, Germany
Completed
Praxis Fr. Dr. H. TäschnerLeipzig, 04249, Germany
Completed
Praxis Hr. Dr. D. HennigMeißen, 01662, Germany
Completed
Praxis Hr. Dr. K. SperlingHamburg, 22299, Germany
Completed
Praxis Drs. F. Merfort / M. Stammen / S. van HaagGrevenbroich, 41515, Germany
Completed
Klinikum Leverkusen gGmbHLeverkusen, 51375, Germany
Completed
Diabetes-Forschungs-InstitutDüsseldorf, 40225, Germany
Completed
Praxis Hr. Prof. Dr. H. PorstHamburg, 20354, Germany
Completed
Universitätsklinikum MünsterMünster, 48149, Germany
Completed
Klinikum der Universität RegensburgRegensburg, 93053, Germany
Completed
Universitäts-Krankenhaus EppendorfHamburg, 20251, Germany
Completed
Praxis Hr. Dr. A. von KeitzMarburg, 35039, Germany
Completed
Praxis Hr. Dr. W. WarnackHagenow, 19230, Germany

Primary Outcome

  • Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)
    date_rangeTime Frame:
    12- 24 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • SEP 2
    date_rangeTime Frame:
    12- 24 weeks
    enhanced_encryption
    Safety Issue:
    no
  • SEP 3
    date_rangeTime Frame:
    12- 24 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

A randomized, explorative, double-blind, double-dummy, multi-center, parallel group study to assess sustainable efficacy of once daily vardenafil (10 mg) for 12 and 24 weeks versus vardenafil PRN in men with mild or mild to moderate ED
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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