NCT00662441
Completed
Phase 4
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
ConditionsErectile Dysfunction
InterventionsLevitra (Vardenafil, BAY38-9456)
Overview
- Phase
- Phase 4
- Intervention
- Levitra (Vardenafil, BAY38-9456)
- Conditions
- Erectile Dysfunction
- Sponsor
- Bayer
- Enrollment
- 102
- Primary Endpoint
- International Index of Erectile Function- Erectile Function domain
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm 1
Intervention: Levitra (Vardenafil, BAY38-9456)
Outcomes
Primary Outcomes
International Index of Erectile Function- Erectile Function domain
Time Frame: 8 weeks
Secondary Outcomes
- Global Assessment Questionnaire (GAQ)(8 weeks)
- Safety and tolerability(8 weeks)
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