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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00654680
First received: April 4, 2008
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

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

Additional Information:
No publications provided

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
Vardenafil

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

ClinicalTrials.gov processed this record on April 15, 2014