Study Completed

Erectile Dysfunction

Bayer Identifier:

100477

ClinicalTrials.gov Identifier:

NCT00663598

EudraCT Number:

Not Available

EU CT Number:

Not Available

Levitra® - Real Life Safety and Efficacy of Levitra

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)

Key Participants Requirements

Sex

Male

Age

18 Years

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

October 2003 - September 2004

Phase

Phase 4

Could I Receive a placebo

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		United States

Primary Outcome

Improvement of Erectile Disfunction
Time Frame:
8 weeks
Safety Issue:
no
Onset of Drug Effect
Time Frame:
8 weeks
Safety Issue:
no
Second successful intercourse
Time Frame:
8 weeks
Safety Issue:
no

Secondary Outcome

General Safety Parameters
Time Frame:
8 weeks
Safety Issue:
yes

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

Additional Information

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