Clinical Trial Details

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Study ID 11334
Investigator
Bayer Study Director,   Bayer
Title A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.
Conditions Erectile Dysfunction
Interventions Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase Phase 4
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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
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
  • Study Location
    Contact

    Information objtained from ClinicalTrials.gov, on 11/1/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00668096


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