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Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
This study has been completed.

First Received on April 18, 2008.   Last Updated on June 16, 2009   History of Changes
Sponsor: Bayer
Collaborator: GlaxoSmithKline
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00681772
  Purpose

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Multi-Centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction
Drug Information available for: Vardenafil Vardenafil dihydrochloride
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:
  • Sexual Encounter Profile Question 2 and 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Assessment Question [ 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: 333
Study Start Date: March 2003
Study Completion Date: November 2003
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 1 hours before sexual intercourse

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men >/= 18 years of age, with
  • ED 6 months or longer
  • Stable sexual relationship for > 6 month.

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy
  • Other exclusion criteria apply according to the Summary of Product Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681772

Sponsors and Collaborators
Bayer
GlaxoSmithKline
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00681772     History of Changes
Other Study ID Numbers: 100541
Study First Received: April 18, 2008
Last Updated: June 16, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   Australia: National Health and Medical Research Council

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 February 09, 2012



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