Original Query: ALL
Previous Study | Return to List | Next Study

Evaluating the Efficacy and Safety of Vardenafil in Patients Erectile Dysfunction Solely Secondary to Spinal Cord Injury

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: NCT00654680
Recruitment Status : Completed
First Posted : April 9, 2008
Last Update Posted : September 30, 2013
Information provided by (Responsible Party):

Brief Summary:
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Rand, db, Parallel-group, Plac-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Plac in Subjects With ED Solely Secondary to Traumatic Spinal Cord Injury
Study Start Date : October 2002
Primary Completion Date : January 2004
Study Completion Date : January 2004

Arm Intervention/treatment
Experimental: Arm 1 Drug: Vardenafil (Levitra, BAY38-9456)
5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse
Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo

Primary Outcome Measures :
  1. International Index of Erectile Function-Erectile Function domain [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ]
  2. Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ]
  3. Other diary based variables [ Time Frame: 12 weeks ]
  4. Safety and tolerability [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males ≥18 years with erectile dysfunction (ED) solely as a result of traumatic spinal cord injury (SCI) for ≥6 months with demonstrated 50% failure in intercourse attempts during the 4-week run-in period.
  • Stable heterosexual relationship for at least 1 month.

Exclusion Criteria:

  • Subjects with unstable medical or psychiatric conditions or using prohibited concomitant medications
  • 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 US Product Information or 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 identifier (NCT number): NCT00654680

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT00654680     History of Changes
Other Study ID Numbers: 10473
First Posted: April 9, 2008    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: September 2013

Keywords provided by Bayer:
Erectile Dysfunction
Traumatic spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Erectile Dysfunction
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
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