Official Title: “A Randomized, Open-Label, Multi-Center, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil in Comparison to Tadalafil in Males With Erectile Dysfunction and a Diagnosis of Diabetes, Hypertension or Hyperlipidemia”

Assessment of efficacy of vardenafil in subjects with erectile dysfunction and diabetes, hypertension or hyperlipidemia

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • 10 mg one hour prior to sexual intercourse
• Drug: Tadalafil
  • 10 mg taken approximately 24 hours prior to sexual intercourse

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Sexual encounter profile question 3 observed within 15 minutes to 4 hours for vardenafil and 22 to 26 hours for the tadalafil group
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Sexual encounter profile question 2
  • Time Frame: 4 weeks
    Safety Issue?: No
• Hardness of erection
  • Time Frame: 4 weeks
    Safety Issue?: No
• Other diary based variables
  • Time Frame: 4 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 4 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Age: 18 years and older
• Males with erectile dysfunction
• Stable heterosexual relationship
• Medical history / diagnosis of diabetes mellitus and/or hypertension and/or hyperlipidemia

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 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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668109

Study ID Number: 10893

ClinicalTrials.gov Identifier: NCT00668109

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

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