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Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662441
First Posted: April 21, 2008
Last Update Posted: June 22, 2009
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.
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
  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 purpose was the evaluation of efficacy and safety of 10 mg oral Vardenafil in Nigerian subjects with Erectile Dysfunction (ED).

Condition Intervention Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Multi-Centre, Study of Levitra 10 mg Once a Day in Males With Erectile Dysfunction Was Carried Out in Four Centres Namely Lagos, Port Harcourt, Enuge and Maiduguri at Their University Teaching Hospitals

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: 8 weeks ]

Secondary Outcome Measures:
  • Global Assessment Questionnaire (GAQ) [ Time Frame: 8 weeks ]
  • Safety and tolerability [ Time Frame: 8 weeks ]

Enrollment: 102
Study Start Date: September 2003
Study Completion Date: June 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
10mg taken 1 hours before sexual intercourse

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Men >/= 18 years of age
  • Erectile Dysfunction

Exclusion Criteria:

  • 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
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): NCT00662441


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

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00662441     History of Changes
Other Study ID Numbers: 100578
First Submitted: April 16, 2008
First Posted: April 21, 2008
Last Update Posted: June 22, 2009
Last Verified: June 2009

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