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

Sponsor:	Bayer
Collaborator:	GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00656188

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

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

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

Additional 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

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00656188 History of Changes
Other Study ID Numbers:	10898, GSK 001
Study First Received:	April 4, 2008
Last Updated:	June 19, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012