Trial Condition(s):
Erectile Dysfunction
Levitra® - Real Life Safety and Efficacy of Levitra (REALISE)
Bayer Identifier:
100477
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)
Inclusion Criteria
- Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment
Exclusion Criteria
- Exclusion according to US PI
Trial Summary
Enrollment Goal
30825
Trial Dates
Phase
4
Could I receive a placebo?
No
Products
N/A
Accepts Healthy Volunteers
No
Where to Participate
Locations
| Locations |
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Trial Design
REALISE Levitra® - Real Life Safety and Efficacy of Levitra
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Improvement of Erectile DisfunctionTimeframe: 8 weeks
- Onset of Drug EffectTimeframe: 8 weeks
- Second successful intercourseTimeframe: 8 weeks
Secondary Outcome
- General Safety ParametersTimeframe: 8 weeks
Additional Information
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