check_circleStudy Completed

Erectile Dysfunction, Diabetes Mellitus

Bayer Identifier:

100607

ClinicalTrials.gov Identifier:

NCT00678704

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY38-9456 - Pivotal trial for diabetes patient

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

20 - 64 Years
  • - 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
  • - 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

Trial summary

Enrollment Goal
790
Trial Dates
January 2004 - November 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Primary Outcome

  • The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15
    date_rangeTime Frame:
    At 12 weeks after start of study drug administration using data at LOCF to account for dropouts
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • The Global Assessment Question
    date_rangeTime Frame:
    At 4, 8, 12 weeks after start of study drug administration and LOCF
    enhanced_encryption
    Safety Issue:
    no
  • The IIEF EF domain score
    date_rangeTime Frame:
    At 4, 8, 12 weeks after start of study drug administration
    enhanced_encryption
    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)]
    date_rangeTime Frame:
    At 4, 8, 12 weeks after start of study drug administration and LOCF
    enhanced_encryption
    Safety Issue:
    no
  • Scores of Questions 1 to 15 on the IIEF Questionnaire
    date_rangeTime Frame:
    At 4, 8, 12 weeks after start of study drug administration and LOCF
    enhanced_encryption
    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
    date_rangeTime Frame:
    At 4, 8, 12 weeks after start of study drug administration and LOCF
    enhanced_encryption
    Safety Issue:
    no
  • Safety data
    date_rangeTime Frame:
    Throughout the study
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
3

Additional Information

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