Assessment of Efficacy of Vardenafil, Influence on Self-Esteem and Self-Confidence in Subjects With Erectile Dysfunction - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00661596

Purpose

Erectile problems may lead to anxiety, loss of self-steem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-steem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-steem and sexual activity.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Multi-Centre, Randomised, Double-Blind, Parallel, Placebo-Controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-Esteem and Self-Confidence in Patients With Erectile Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

International Index of Erectile Function - Erectile Function Domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global Assessment Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
IIEF-EF domain score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Other 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:	150
Study Start Date:	May 2003
Study Completion Date:	January 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 5 mg, 10 mg and 20 mg one hour prior to sexual intercourse
Arm 2: Placebo Comparator	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:

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
Other exclusion criteria apply acc. to Summary of Product Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661596

Locations

Spain

Valencia, Spain, 46014

Alicante, Spain, 03010

Granada, Spain, 18003

Málaga, Spain, 29010

Sevilla, Spain, 41071

Valladolid, Spain, 47011
Spain, Asturias

Oviedo, Asturias, Spain, 33006
Spain, Barcelona

Sabadell, Barcelona, Spain, 08208
Spain, Cataluña

Barcelona, Cataluña, Spain, 08025
Spain, Guipuzcoa

Hondarribia, Guipuzcoa, Spain, 28280
Spain, Madrid

Leganés, Madrid, Spain, 28911

Móstoles, Madrid, Spain, 28935
Spain, Pontevedra

Vigo, Pontevedra, Spain, 36211

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	11139
Study First Received:	April 15, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00661596 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010