Status:
COMPLETED
BAY38-9456 - Supportive Trial for Spinal Injury
Lead Sponsor:
Bayer
Conditions:
Erectile Dysfunction
Sexual Dysfunction
Eligibility:
MALE
20-64 years
Phase:
PHASE3
Brief Summary
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 u...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2004
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00652262
Start Date
March 1 2004
End Date
November 1 2004
Last Update
December 23 2014
Active Locations (3)
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1
Nagoya, Aichi-ken, Japan, 455-8530
2
Iizuka, Fukuoka, Japan, 820-0053
3
Beppu, Oita Prefecture, Japan, 874-0937