Levitra® - Real Life Safety and Efficacy of Levitra

REALISE Levitra® - Real Life Safety and Efficacy of Levitra

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663598

Acronym

REALISE

Enrollment

30825

Registered

2008-04-22

Start date

2003-10-31

Completion date

2004-09-30

Last updated

2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, Vardenafil

Brief summary

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)

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

Treatment according to US PI

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Improvement of Erectile Disfunction	8 weeks
Onset of Drug Effect	8 weeks
Second successful intercourse	8 weeks

Secondary

Measure	Time frame
General Safety Parameters	8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026