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Trial record 1 of 1 for:    NCT00662441
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Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT00662441
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : June 22, 2009
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
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
Study Start Date : September 2003
Actual Study Completion Date : June 2004

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
10mg taken 1 hours before sexual intercourse


Outcome Measures
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Primary Outcome Measures :
  1. International Index of Erectile Function- Erectile Function domain [ Time Frame: 8 weeks ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00662441    
Other Study ID Numbers: 100578
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009
Keywords provided by Bayer:
Erectile Dysfunction
Vardenafil
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
 Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents