Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

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

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 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
Primary Completion Date : May 2003
Study Completion Date : May 2003

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

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 ]

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

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

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 identifier (NCT number): NCT00656188

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00656188     History of Changes
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

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