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

NCT ID: NCT00654680

Last Updated: 2013-09-30

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

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Erectile Dysfunction Traumatic spinal cord injury Vardenafil

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

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Other Identifiers

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10473

Identifier Type: -

Identifier Source: org_study_id