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Trial record 1 of 1 for:    NCT00656188
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Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT00656188
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : October 10, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 463 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
Study Start Date : October 2002
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo
Active Comparator: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse


Outcome Measures
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Primary Outcome Measures :
  1. Erectile Function domain of the International Index of Erectile Function [ Time Frame: 12 weeks ]
  2. Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ]
  3. Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Erectile Function domain scores > 26 [ Time Frame: 12 weeks ]
  2. Sexual Encounter Profile 2 [ Time Frame: 12 weeks ]
  3. Global Assessment Question [ Time Frame: 12 weeks ]
  4. Reliability of insertion [ Time Frame: 12 weeks ]
  5. Reliability of maintenance [ Time Frame: 12 weeks ]
  6. Other subject diary based variables [ Time Frame: 12 weeks ]
  7. Safety and tolerability [ Time Frame: 12 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, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • 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
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): NCT00656188


Sponsors and Collaborators
Bayer
GlaxoSmithKline
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00656188    
Other Study ID Numbers: 10898
GSK 001
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013
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