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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 4, 2008
Last updated: September 26, 2013
Last verified: September 2013
Investigate efficacy and safety of Vardenafil in patients with spinal cord injury

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • International Index of Erectile Function-Erectile Function domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Other diary based variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 418
Study Start Date: October 2002
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654680

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00654680     History of Changes
Other Study ID Numbers: 10473 
Study First Received: April 4, 2008
Last Updated: September 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Erectile Dysfunction
Traumatic spinal cord injury

Additional relevant MeSH terms:
Erectile Dysfunction
Spinal Cord Injuries
Central Nervous System Diseases
Genital Diseases, Male
Mental Disorders
Nervous System Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Vardenafil Dihydrochloride
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 26, 2016