Levitra® - Real Life Safety and Efficacy of Levitra - Tabular View

Tracking Information

First Received Date ^ICMJE

April 17, 2008

Last Updated Date

June 5, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Improvement of Erectile Disfunction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Onset of Drug Effect [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Second successful intercourse [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00663598 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

General Safety Parameters [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

General Safety [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

Levitra® - Real Life Safety and Efficacy of Levitra

Official Title ^ICMJE

REALISE Levitra® - Real Life Safety and Efficacy of Levitra

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)

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Drug: Levitra (Vardenafil, BAY38-9456)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

30000

Completion Date

September 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00663598

Responsible Party

Medical Affairs Therapeutic Area Head, Bayer Healthcare AG

Study ID Numbers ^ICMJE

100477

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP