A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
FINDER
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.
1 other identifier
interventional
260
7 countries
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2004
Shorter than P25 for phase_4
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 24, 2008
CompletedFirst Posted
Study publicly available on registry
April 28, 2008
CompletedDecember 25, 2014
December 1, 2014
8 months
April 24, 2008
December 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
16 weeks
Secondary Outcomes (4)
International Index of Erectile Function
16 weeks
Treatment Satisfaction Scale
16 weeks
Other patient diary based variables
16 weeks
Safety and tolerability
16 weeks
Study Arms (2)
Arm 2
PLACEBO COMPARATORArm 1
EXPERIMENTALInterventions
Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (38)
Unknown Facility
Bruxelles - Brussel, 1000, Belgium
Unknown Facility
Drieslinter, 3350, Belgium
Unknown Facility
Genk, 3600, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Gentofte Municipality, DK-2820, Denmark
Unknown Facility
Næstved, 4700, Denmark
Unknown Facility
Svendborg, DK-5700, Denmark
Unknown Facility
Viborg, 8800, Denmark
Unknown Facility
Kerava, 04250, Finland
Unknown Facility
Oulu, 90100, Finland
Unknown Facility
Tampere, 33100, Finland
Unknown Facility
Grenoble, 38000, France
Unknown Facility
Lille, 59000, France
Unknown Facility
Lyon, 69000, France
Unknown Facility
Marseille, 13009, France
Unknown Facility
Marseille, 13013, France
Unknown Facility
Marseille, 13015, France
Unknown Facility
Montpellier, 34000, France
Unknown Facility
Hamburg, Hamburg, 22177, Germany
Unknown Facility
Hamburg, Hamburg, 22299, Germany
Unknown Facility
Hamburg, Hamburg, 22303, Germany
Unknown Facility
Dresden, Saxony, 01129, Germany
Unknown Facility
Leipzig, Saxony, 04105, Germany
Unknown Facility
Leipzig, Saxony, 04249, Germany
Unknown Facility
Leisnig, Saxony, 04703, Germany
Unknown Facility
Meissen, Saxony, 01662, Germany
Unknown Facility
Harrislee, Schleswig-Holstein, 24955, Germany
Unknown Facility
Norderstedt, Schleswig-Holstein, 22846, Germany
Unknown Facility
Wahlstedt, Schleswig-Holstein, 23812, Germany
Unknown Facility
Altenburg, Thuringia, 04600, Germany
Unknown Facility
Barcelona, Barcelona, 08032, Spain
Unknown Facility
Gavà, Barcelona, 08850, Spain
Unknown Facility
L'Hospitalet de Llobregat, Barcelona, 08905, Spain
Unknown Facility
Badalona (Barcelona), Catalonia, 08043, Spain
Unknown Facility
Crowborough, East Sussex, TN6 1DL, United Kingdom
Unknown Facility
Chipping Norton, Oxfordshire, OX7 5AL, United Kingdom
Unknown Facility
Lichfield, Staffordshire, WS14 9JL, United Kingdom
Unknown Facility
Hamilton, Strathclyde, ML3 ODR, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2008
First Posted
April 28, 2008
Study Start
May 1, 2004
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
December 25, 2014
Record last verified: 2014-12