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BAY38-9456 - Supportive Trial for Spinal Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00652262
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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
Study Start Date : March 2004
Actual Study Completion Date : November 2004

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. The Global Assessment Question [ Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF ]
  2. The IIEF EF domain score [ Time Frame: At 4, 8, 12 weeks after start of study drug administration ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Safety data [ Time Frame: Throughout the study ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652262


Locations
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Japan
Nagoya, Aichi, Japan, 455-8530
Iizuka, Fukuoka, Japan, 820-0053
Beppu, Oita, Japan, 874-0937
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00652262    
Other Study ID Numbers: 100608
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Vardenafil
PDE5 inhibitor
Erectile dysfunction
Spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Erectile Dysfunction
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
 Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents