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Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT00658177
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : December 2, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer

Brief Summary:
Study to investigate the efficacy and safety of Vardenafil

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

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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 : June 2003
Actual Study Completion Date : February 2004


Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
20mg to be taken 1 h prior to sexual intercourse

Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ]
  2. Internation Index of Erectile Function-Erectile Function domain [ Time Frame: 12 weeks ]
  3. Safety and tolerability [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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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
  • Other exclusion criteria apply according to the US Product Information

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): NCT00658177


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

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00658177     History of Changes
Other Study ID Numbers: 100497
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Erectile dysfunction
Vardenafil
Additional relevant MeSH terms:
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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