Erectile Dysfunction Clinical Trial
— REALISEOfficial title:
REALISE Levitra® - Real Life Safety and Efficacy of Levitra
Verified date | December 2014 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 30825 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of Erectile Disfunction | 8 weeks | No | |
Primary | Onset of Drug Effect | 8 weeks | No | |
Primary | Second successful intercourse | 8 weeks | No | |
Secondary | General Safety Parameters | 8 weeks | Yes |
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