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

Sponsors and Collaborators:	Bayer GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00656188

Purpose

Study to investigate the efficacy and safety of Vardenafil

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

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: 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:

Erectile Function domain of the International Index of Erectile Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Erectile Function domain scores > 26 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Sexual Encounter Profile 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Global Assessment Question [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Reliability of insertion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Reliability of maintenance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Other subject diary based variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	463
Study Start Date:	October 2002
Study Completion Date:	January 2004

Arms	Assigned Interventions
Arm 2: Placebo Comparator	Drug: Placebo Matching placebo
Arm 1: Active Comparator	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse

Detailed Description:

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. This also called impotence is a significant issue for men and their partners with increasing prevalence and with more men seeking treatment. Non-response to sildenafil has been reported by men and presents a challenge to those seeking treatment. This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656188

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:	10898, GSK 001
Study First Received:	April 4, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00656188
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 January 16, 2009