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Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

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ClinicalTrials.gov Identifier: NCT00661297
Recruitment Status : Completed
First Posted : April 18, 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 523 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction
Study Start Date : June 2003
Study Completion Date : January 2004


Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil to be taken 1 h prior to sexual attempt
Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo



Primary Outcome Measures :
  1. Sexual Encounter Profile question 2 (SEP 2) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Sexual Encounter Profile question 3 (SEP 3) [ Time Frame: 12 weeks ]
  2. International Index of Erectile Function (IIEF) - EF (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, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heterosexual males
  • >/= 18 years old with ED for more than six months
  • Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

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

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): NCT00661297


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00661297     History of Changes
Other Study ID Numbers: 100536
First Posted: April 18, 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:
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