Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662441
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : June 22, 2009
Information provided by:

April 16, 2008
April 21, 2008
June 22, 2009
September 2003
Not Provided
International Index of Erectile Function- Erectile Function domain [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT00662441 on Archive Site
  • Global Assessment Questionnaire (GAQ) [ Time Frame: 8 weeks ]
  • Safety and tolerability [ Time Frame: 8 weeks ]
Same as current
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Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction
Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).
Not Provided
Phase 4
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
10mg taken 1 hours before sexual intercourse
Experimental: Arm 1
Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2004
Not Provided

Inclusion Criteria:

  • Men >/= 18 years of age
  • Erectile Dysfunction

Exclusion Criteria:

  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy
  • Other exclusion criteria apply according to the Summary of Product Characteristics
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
Study Director: Bayer Study Director Bayer
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP