Official Title: “An Open-Label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug”

Assess efficacy of vardenafil within 6 hours after intake

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • Vardenafil 10mg orally on demand prior to intercourse

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1

Primary Measures

• Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• International Index of Erectile Function
  • Time Frame: 12 weeks
    Safety Issue?: No
• Global Assessment Question (GAQ)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Other diary responses
  • Time Frame: 12 weeks
    Safety Issue?: No
• General Safety
  • 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

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/NCT00668018

Study ID Number: 10678

ClinicalTrials.gov Identifier: NCT00668018

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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