BAY38-9456 - Pivotal Trial for Diabetes Patient
Primary Purpose
Erectile Dysfunction, Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Levitra (Vardenafil, BAY38-9456)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Vardenafil, PDE5 inhibitor, Erectile Dysfunction, Diabetes Mellitus, Sexual Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
- Diabetes for more than 3 years
Exclusion Criteria:
- Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
- Spinal cord injury
- History of surgical prostatectomy (excluding TURP)
- Patients with an HbA1c > 12% at Visit 1
- Use of nitrates
- Use of potent CYP3a4 inhibitors
- Severe liver disease
- Presence of Peyronie's Disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Arm 3
Arm 1
Arm 2
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
NCT00678704
Brief Title
BAY38-9456 - Pivotal Trial for Diabetes Patient
Official Title
A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 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
The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Diabetes Mellitus
Keywords
Vardenafil, PDE5 inhibitor, Erectile Dysfunction, Diabetes Mellitus, Sexual Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
790 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
BAY 38-9456 10 mg tablet prior to intercourse on demand
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
BAY 38-9456 20 mg tablet prior to intercourse on demand
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet prior to intercourse on demand
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 for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
Diabetes for more than 3 years
Exclusion Criteria:
Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
Spinal cord injury
History of surgical prostatectomy (excluding TURP)
Patients with an HbA1c > 12% at Visit 1
Use of nitrates
Use of potent CYP3a4 inhibitors
Severe liver disease
Presence of Peyronie's Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
BAY38-9456 - Pivotal Trial for Diabetes Patient
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