NCT00652262

BAY38-9456 - Supportive Trial for Spinal Injury

An Open, Multi-centre, Flexible Dose Uptitration Study to Investigate the Efficacy and Safety of Vardenafil 10 mg and 20 mg in Males With Spinal Cord Injury Suffering From Erectile Dysfunction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

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 uptitration to BAY 38-9456 20 mg when the treatment with 10 mg is not sufficiently effective

Conditions

• Erectile Dysfunction
• Sexual Dysfunction
• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2004-03-01
• Completion: 2004-11-01
• First posted: 2008-04-03
• Last updated: 2014-12-23

Locations

3 sites across 1 country: Japan