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BAY38-9456 - Supportive Trial for Spinal Injury

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00652262
First received: April 1, 2008
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  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


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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Global Assessment Question [ Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF ] [ Designated as safety issue: No ]
  • The IIEF EF domain score [ Time Frame: At 4, 8, 12 weeks after start of study drug administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety data [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 30
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.

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652262

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

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00652262     History of Changes
Other Study ID Numbers: 100608
Study First Received: April 1, 2008
Last Updated: June 19, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Spinal Cord Injuries
Spinal Injuries
Erectile Dysfunction
Sexual and Gender Disorders
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Back Injuries
 Sexual Dysfunction, Physiological
Genital Diseases, Male
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013