NCT00654680

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
418

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 9, 2008

Completed
Last Updated

September 30, 2013

Status Verified

September 1, 2013

Enrollment Period

1.3 years

First QC Date

April 4, 2008

Last Update Submit

September 26, 2013

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionTraumatic spinal cord injuryVardenafil

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Function-Erectile Function domain

    12 weeks

Secondary Outcomes (4)

  • Sexual Encounter Profile Question 2

    12 weeks

  • Sexual Encounter Profile Question 3

    12 weeks

  • Other diary based variables

    12 weeks

  • Safety and tolerability

    12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Vardenafil (Levitra, BAY38-9456)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Vardenafil (Levitra, BAY38-9456)DRUG

5mg, 10mg or 20mg taken 1 hour prior to sexual intercourse

Arm 1
PlaceboDRUG

Matching placebo

Arm 2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 9, 2008

Study Start

October 1, 2002

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

September 30, 2013

Record last verified: 2013-09