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BAY38-9456 - Supportive Trial for Spinal Injury

NCT ID: NCT00652262

Last Updated: 2014-12-23

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2004-11-30

Brief Summary

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BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be improved by uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective

Detailed Description

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Conditions

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Erectile Dysfunction Sexual Dysfunction Spinal Cord Injury

Keywords

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Vardenafil PDE5 inhibitor Erectile dysfunction Spinal cord injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.

Interventions

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Levitra (Vardenafil, BAY38-9456)

Patients received BAY 38-9456 10 mg for the first 4 weeks of the treatment period, and then went on to receive 10 mg or 20 mg for the following 8 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male with erectile dysfunction according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance), solely as a result of a traumatic injury to the spinal cord (suffering more than 6 months ago)
* Patients answering "yes" to the question regarding the presence of residual erectile function over the past 6 months \[At home over the past 6 months, have you experienced at least some enlargement of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?\]

Exclusion Criteria

* History of diabetes mellitus
* Patients who are taking nitrates or nitric oxide donors
* Patients who have experienced no enlargement of penis with PDE5 inhibitor and/or who have withdrew the use of PDE5 inhibitor due to ADRs
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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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

Locations

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Nagoya, Aichi-ken, Japan

Site Status

Iizuka, Fukuoka, Japan

Site Status

Beppu, Oita Prefecture, Japan

Site Status

Countries

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Japan

Other Identifiers

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100608

Identifier Type: -

Identifier Source: org_study_id