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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00661596
First received: April 15, 2008
Last updated: June 29, 2009
Last verified: June 2009
  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 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: 150
Study Start Date: May 2003
Study Completion Date: January 2004
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

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
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 ClinicalTrials.gov identifier: 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:
No publications provided

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

Keywords provided by Bayer:
Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014