Back to resultsBAY38-9456 - Supportive Trial for Spinal Injury
Primary Purpose
Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Vardenafil, PDE5 inhibitor, Erectile dysfunction, Spinal cord injury
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
Secondary Outcome Measures
The Global Assessment Question
The IIEF EF domain score
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)]
Scores of Questions 1 to 15 on the IIEF Questionnaire
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
Safety data
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00652262
Brief Title
BAY38-9456 - Supportive Trial for Spinal Injury
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Sexual Dysfunction, Spinal Cord Injury
Keywords
Vardenafil, PDE5 inhibitor, Erectile dysfunction, Spinal cord injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The Global Assessment Question
Time Frame
At 4, 8, 12 weeks after start of study drug administration and LOCF
Title
The IIEF EF domain score
Time Frame
At 4, 8, 12 weeks after start of study drug administration
Title
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
Title
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
Title
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
Title
Safety data
Time Frame
Throughout the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-0053
Country
Japan
City
Beppu
State/Province
Oita
ZIP/Postal Code
874-0937
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
BAY38-9456 - Supportive Trial for Spinal Injury
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