Trial Condition(s):
Erectile Dysfunction
A randomised study of Levitra to treat men with erections problems and previously untreated with similar therapy. (FINDER)
Bayer Identifier:
11334
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site BRUXELLES - BRUSSEL, Belgium, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 22299 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oulu, Finland, 90100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site DRIESLINTER, Belgium, 3350 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Westbury, United Kingdom, BA13 3FQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site GENK, Belgium, 3600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Naestved, Denmark, 4700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tampere, Finland, 33100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Crowborough, United Kingdom, TN6 1DL | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kerava, Finland, 04250 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LYON, France, 69000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Harrislee, Germany, 24955 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meißen, Germany, 01662 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leisnig, Germany, 04703 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Altenburg, Germany, 04600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04105 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gentofte, Denmark, DK-2820 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chipping Norton, United Kingdom, OX7 5AL | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 22303 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamburg, Germany, 22177 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Wahlstedt, Germany, 23812 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hamilton, United Kingdom, ML3 ODR | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Leipzig, Germany, 04249 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site MARSEILLE, France, 13015 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01099 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site LILLE, France, 59000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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.Timeframe: 16 weeks
Secondary Outcome
- International Index of Erectile FunctionTimeframe: 16 weeks
- Treatment Satisfaction ScaleTimeframe: 16 weeks
- Other patient diary based variablesTimeframe: 16 weeks
- Safety and tolerabilityTimeframe: 16 weeks
Additional Information
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