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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00661596
First Posted: April 18, 2008
Last Update Posted: December 30, 2014
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.
Information provided by (Responsible Party):
Bayer
  Purpose
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 Intervention Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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

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

Enrollment: 129
Study Start Date: May 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): NCT00661596


Locations
Spain
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00661596     History of Changes
Other Study ID Numbers: 11139
First Submitted: April 15, 2008
First Posted: April 18, 2008
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:
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