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Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661596
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : December 30, 2014
Information provided by (Responsible Party):

Brief Summary:
Erectile problems may lead to anxiety, loss of self-esteem 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-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2003
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5 mg, 10 mg and 20 mg one hour prior to sexual intercourse

Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo

Primary Outcome Measures :
  1. International Index of Erectile Function - Erectile Function Domain [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Global Assessment Questionnaire [ Time Frame: 12 weeks ]
  2. IIEF-EF domain score [ Time Frame: 12 weeks ]
  3. Other diary based variables [ Time Frame: 12 weeks ]
  4. Safety and tolerability [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661596

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Oviedo, Asturias, Spain, 33006
Sabadell, Barcelona, Spain, 08208
Barcelona, Cataluña, Spain, 08025
Hondarribia, Guipuzcoa, Spain, 28280
Leganés, Madrid, Spain, 28911
Móstoles, Madrid, Spain, 28935
Vigo, Pontevedra, Spain, 36211
Alicante, Spain, 03010
Granada, Spain, 18003
Málaga, Spain, 29010
Sevilla, Spain, 41071
Valencia, Spain, 46014
Valladolid, Spain, 47011
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer Identifier: NCT00661596    
Other Study ID Numbers: 11139
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Erectile Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents