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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00662441
First received: April 16, 2008
Last updated: June 19, 2009
Last verified: June 2009

April 16, 2008
June 19, 2009
September 2003
Not Provided
International Index of Erectile Function- Erectile Function domain [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662441 on ClinicalTrials.gov Archive Site
  • Global Assessment Questionnaire (GAQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00662441
100578
No
Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
Bayer
GlaxoSmithKline
Study Director: Bayer Study Director Bayer
Bayer
June 2009

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