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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
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    April 1, 2008
    Last Updated
    December 18, 2014
    Sponsor
    Bayer
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    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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