Trial Condition(s):
Erectile Dysfunction
Evaluating of the efficacy and safety of Vardenafil in subjects with erectile dysfunction
Bayer Identifier:
100578
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Nigeria | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
1
Primary Outcome
- International Index of Erectile Function- Erectile Function domainTimeframe: 8 weeks
Secondary Outcome
- Global Assessment Questionnaire (GAQ)Timeframe: 8 weeks
- Safety and tolerabilityTimeframe: 8 weeks
Additional Information
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