Trial Condition(s):

Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury

BAY38-9456 - Supportive trial for spinal injury

Bayer Identifier:

100608

ClinicalTrials.gov Identifier:

NCT00652262

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
32
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Beppu, Japan, 874-0937

Status
Completed
 
Locations

Investigative Site

Iizuka, Japan, 820-0053

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 455-8530

Status
Completed
 

Trial Design