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BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

Phase 3
Completed
Conditions
Erectile Dysfunction
Interventions
Registration Number
NCT00668057
Lead Sponsor
Bayer
Brief Summary

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
624
Inclusion Criteria
  • Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
  • Stable heterosexual relationship
Exclusion Criteria
  • Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
  • Nitrate use
  • Other exclusion criteria apply

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm 3Levitra (Vardenafil, BAY38-9456)-
Arm 4Placebo-
Arm 6Placebo-
Arm 1Levitra (Vardenafil, BAY38-9456)-
Arm 5Placebo-
Arm 2Levitra (Vardenafil, BAY38-9456)-
Primary Outcome Measures
NameTimeMethod
Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 1512 weeks
Secondary Outcome Measures
NameTimeMethod
Safety and tolerability12 weeks
Erectile Function domain score of the International Index of Erectile Function12 weeks
Global Assessment Questionnaire12 weeks

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