Study Evaluating the Efficacy and Safety of Flexible-Dose Vardenafil in Subjects With Erectile Dysfunction - Full Text View

Purpose

Study to investigate the efficacy and safety of Vardenafil

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

MedlinePlus related topics:

Erectile Dysfunction

ChemIDplus related topics:

Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-Dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

Further study details as provided by Bayer:

Primary Outcome Measures:

Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Internation Index of Erectile Function-Erectile Function domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	761
Study Start Date:	June 2003
Study Completion Date:	February 2004

Arms	Assigned Interventions
Arm 1: Experimental n/a	Drug: Levitra (Vardenafil, BAY38-9456) 20mg to be taken 1 h prior to sexual intercourse
Arm 2: Placebo Comparator n/a	Drug: Placebo Matching placebo

Eligibility

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

Criteria

Inclusion Criteria:

Men ≥18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
History of unresponsiveness to sildenafil
Stable sexual relationship for > 6 month.

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
Nitrate therapy
Other exclusion criteria apply according to the US Product Information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658177

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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 by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

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

Responsible Party:	( Bayer HealthCare AG, Therapeutic Area Head )
Study ID Numbers:	100497
First Received:	April 9, 2008
Last Updated:	April 9, 2008
ClinicalTrials.gov Identifier:	NCT00658177
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

Vardenafil

Sexual Dysfunction, Physiological

Mental Disorders

Genital Diseases, Male

Erectile Dysfunction

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Sexual and Gender Disorders

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	Bayer GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00658177