A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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.
Secondary outcome: International Index of Erectile FunctionTreatment Satisfaction Scale Other patient diary based variables Safety and tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
BRUXELLES 1000, Belgium
DRIESLINTER 3350, Belgium
GENK 3600, Belgium
LEUVEN 3000, Belgium
Gentofte DK-2820, Denmark
Naestved 4700, Denmark
Oulu 90100, Finland
Tampere 33100, Finland
Kerava 04250, Finland
MARSEILLE 13009, France
LYON 69000, France
MARSEILLE 13015, France
LILLE 59000, France
Crowborough, East Sussex TN6 1DL, United Kingdom
Hamburg, Hamburg / 287 22299, Germany
Hamburg, Hamburg / 287 22303, Germany
Hamburg, Hamburg / 287 22177, Germany
Chipping Norton, Oxfordshire OX7 5AL, United Kingdom
Leipzig, Sachsen / 313 04249, Germany
Dresden, Sachsen / 313 01129, Germany
Meißen, Sachsen / 313 01662, Germany
Leisnig, Sachsen / 313 04703, Germany
Leipzig, Sachsen / 313 04105, Germany
Wahlstedt, Schleswig-Holstein / 306 23812, Germany
Harrislee, Schleswig-Holstein / 306 24955, Germany
Lichfield, Staffordshire WS14 9JL, United Kingdom
Hamilton, Strathclyde ML3 ODR, United Kingdom
Altenburg, Thüringen / 310 04600, Germany
Additional Information
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Starting date: May 2004
Ending date: January 2005
Last updated: April 27, 2008
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