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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 15, 2008
Last updated: December 28, 2014
Last verified: December 2014

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
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:

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: 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


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00661596

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
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT00661596     History of Changes
Other Study ID Numbers: 11139
Study First Received: April 15, 2008
Last Updated: December 28, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents processed this record on October 07, 2015