This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

BAY38-9456 - Supportive Trial for Spinal Injury

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 1, 2008
Last updated: December 18, 2014
Last verified: December 2014
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

Condition Intervention Phase
Erectile Dysfunction Sexual Dysfunction Spinal Cord Injury Drug: Levitra (Vardenafil, BAY38-9456) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15 [ Time Frame: At 12 weeks after start of study drug administration using data at LOCF to account for dropouts ]

Secondary Outcome Measures:
  • The Global Assessment Question [ Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF ]
  • The IIEF EF domain score [ Time Frame: At 4, 8, 12 weeks after start of study drug administration ]
  • IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)] [ Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF ]
  • Scores of Questions 1 to 15 on the IIEF Questionnaire [ Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF ]
  • Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation [ Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF ]
  • Safety data [ Time Frame: Throughout the study ]

Enrollment: 32
Study Start Date: March 2004
Study Completion Date: November 2004
Arms Assigned Interventions
Experimental: Arm 1 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.


Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00652262

Nagoya, Aichi, Japan, 455-8530
Iizuka, Fukuoka, Japan, 820-0053
Beppu, Oita, Japan, 874-0937
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00652262     History of Changes
Other Study ID Numbers: 100608
Study First Received: April 1, 2008
Last Updated: December 18, 2014

Keywords provided by Bayer:
PDE5 inhibitor
Erectile dysfunction
Spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Erectile Dysfunction
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents processed this record on September 21, 2017