Official Title: “Multi-Centre, Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-Esteem and Self-Confidence in Patients With Erectile Dysfunction”

Assessment of efficacy of vardenafil, influence on self-esteem and self-confidence in subjects with erectile dysfunction

Study Type: Interventional

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

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress.

The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 5 mg, 10 mg and 20 mg one hour prior to sexual intercourse
• Drug: Placebo
  • Matching placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• International Index of Erectile Function - Erectile Function Domain
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Global Assessment Questionnaire
  • Time Frame: 12 weeks
    Safety Issue?: No
• IIEF-EF domain score
  • Time Frame: 12 weeks
    Safety Issue?: No
• Other diary based variables
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Age: 18 years and older
• Males with erectile dysfunction
• Stable heterosexual relationship

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 acc. to 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: N/A

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 August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661596

Study ID Number: 11139

ClinicalTrials.gov Identifier: NCT00661596

Health Authority: Spain: Spanish Agency of Medicines

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