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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654680

Enrollment

418

Registered

2008-04-09

Start date

2002-10-31

Completion date

2004-01-31

Last updated

2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, Traumatic spinal cord injury, Vardenafil

Brief summary

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

Interventions

DRUGVardenafil (Levitra, BAY38-9456)

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

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
International Index of Erectile Function-Erectile Function domain	12 weeks

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026