check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11334

ClinicalTrials.gov Identifier:

NCT00668096

EudraCT Number:

Not Available

EU CT Number:

Not Available
A randomised study of Levitra to treat men with erections problems and previously untreated with similar therapy.

Trial purpose

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
    - Heterosexual relationship for more than 6 months
    - Partner willing to complete the TSS
  • - Primary hypoactive sexual desire
    - History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
    - Nitrate use
    - Other exclusion criteria apply according to the Summary of Product Characteristics

Trial summary

Enrollment Goal
260
Trial Dates
May 2004 - January 2005
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
BRUXELLES - BRUSSEL, 1000, Belgium
Completed
Hamburg, 22299, Germany
Completed
Oulu, 90100, Finland
Completed
DRIESLINTER, 3350, Belgium
Withdrawn
Svendborg, DK-5700, Denmark
Withdrawn
L'Hospitalet de Llobregat, 08905, Spain
Completed
MARSEILLE, 13009, France
Completed
Westbury, BA13 3FQ, United Kingdom
Completed
GENK, 3600, Belgium
Completed
Naestved, 4700, Denmark
Withdrawn
Barcelona, 08032, Spain
Completed
Tampere, 33100, Finland
Completed
Crowborough, TN6 1DL, United Kingdom
Withdrawn
Viborg, 8800, Denmark
Withdrawn
Gavà, 08850, Spain
Completed
Kerava, 04250, Finland
Completed
LYON, 69000, France
Completed
Harrislee, 24955, Germany
Withdrawn
LYON, 69000, France
Withdrawn
MONTPELLIER, 34000, France
Withdrawn
Norderstedt, 22846, Germany
Completed
Meißen, 01662, Germany
Completed
Leisnig, 04703, Germany
Completed
Altenburg, 04600, Germany
Completed
Leipzig, 04105, Germany
Completed
Gentofte, DK-2820, Denmark
Withdrawn
Badalona (Barcelona), 08043, Spain
Withdrawn
MONTPELLIER, 34000, France
Completed
Chipping Norton, OX7 5AL, United Kingdom
Completed
Hamburg, 22303, Germany
Completed
Hamburg, 22177, Germany
Withdrawn
MARSEILLE, 13013, France
Completed
LEUVEN, 3000, Belgium
Completed
Wahlstedt, 23812, Germany
Completed
Hamilton, ML3 ODR, United Kingdom
Completed
Leipzig, 04249, Germany
Completed
MARSEILLE, 13015, France
Completed
Dresden, 01099, Germany
Withdrawn
GRENOBLE, 38100, France
Completed
LILLE, 59000, France
Withdrawn
Finland

Primary Outcome

  • Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign.
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • International Index of Erectile Function
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Treatment Satisfaction Scale
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Other patient diary based variables
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A randomized, double blind, placebo controlled, flexible dose, multicentre study of Levitra in a broad population of men with Erectile Dysfunction and previously untreated with PDE5 inhibitors.
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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