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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
• Drug: Placebo
  • Matching Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Arm 2
• Experimental: Arm 1

Primary Measures

• 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.
  • Time Frame: 16 weeks
    Safety Issue?: No

Secondary Measures

• International Index of Erectile Function
  • Time Frame: 16 weeks
    Safety Issue?: No
• Treatment Satisfaction Scale
  • Time Frame: 16 weeks
    Safety Issue?: No
• Other patient diary based variables
  • Time Frame: 16 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 16 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668096

Study ID Number: 11334

ClinicalTrials.gov Identifier: NCT00668096

Health Authority: France: Afssaps - French Health Products Safety Agency

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