A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy. - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00668096

Purpose

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.

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:

Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

International Index of Erectile Function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Treatment Satisfaction Scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Other patient diary based variables [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Safety and tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	246
Study Start Date:	May 2004
Study Completion Date:	January 2005

Arms	Assigned Interventions
Placebo Comparator: Arm 2	Drug: Placebo Matching Placebo
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
Heterosexual relationship for more than 6 months
Partner willing to complete the TSS

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
Nitrate use
Other exclusion criteria apply according to the Summary of Product Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668096

Show 38 Study Locations

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 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:	NCT00668096 History of Changes
Other Study ID Numbers:	11334
Study First Received:	April 24, 2008
Last Updated:	June 29, 2009
Health Authority:	France: Afssaps - French Health Products Safety Agency Germany: Federal Institute for Drugs and Medical Devices United Kingdom: National Health Service Belgium: Federal Agency for Medicinal Products and Health Products Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency

Keywords provided by Bayer:

Erectile Dysfunction
PDE5 inhibitors

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Phosphodiesterase 5 Inhibitors

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

ClinicalTrials.gov processed this record on May 24, 2012