Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00668018

Purpose

Assess efficacy of vardenafil within 6 hours after intake

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug

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:

Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

International Index of Erectile Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Global Assessment Question (GAQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Other diary responses [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
General Safety [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	1200
Study Start Date:	January 2003
Study Completion Date:	October 2003

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10mg orally on demand prior to intercourse

Eligibility

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

Criteria

Inclusion Criteria:

Age: 18 years and older
Males with erectile dysfunction
Stable heterosexual relationship

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
Nitrate use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668018

Sponsors and Collaborators

Bayer

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 This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier:	NCT00668018 History of Changes
Other Study ID Numbers:	10678
Study First Received:	April 24, 2008
Last Updated:	March 8, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Bayer:

Male 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