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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2004-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Vardenafil (Levitra, BAY38-9456)

Intervention Type DRUG

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

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Vardenafil (Levitra, BAY38-9456)

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

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No