Clinical Trial: Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Maidu
Brief Summary: 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).
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: International Index of Erectile Function- Erectile Function domain [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Global Assessment Questionnaire (GAQ) [ Time Frame: 8 weeks ]
- Safety and tolerability [ Time Frame: 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: April 16, 2008
Date Started: September 2003
Date Completion:
Last Updated: June 19, 2009
Last Verified: June 2009
