Levitra® - Real Life Safety and Efficacy of Levitra - Full Text View

Levitra® - Real Life Safety and Efficacy of Levitra (REALISE)

This study has been completed.

First Received: April 17, 2008 Last Updated: June 5, 2009 History of Changes

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00663598

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)

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	REALISE Levitra® - Real Life Safety and Efficacy of Levitra

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	30000
Study Start Date:	October 2003
Study Completion Date:	September 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) Treatment according to US PI

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663598

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Healthcare AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	100477
Study First Received:	April 17, 2008
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00663598 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009