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”

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.

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • BAY 38-9456 10 mg tablet prior to intercourse on demand
• Drug: Levitra (Vardenafil, BAY38-9456)
  • BAY 38-9456 20 mg tablet prior to intercourse on demand
• Drug: Placebo
  • Placebo tablet prior to intercourse on demand

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Arm 3
• Experimental: Arm 1
• Experimental: Arm 2

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• The Global Assessment Question
  • Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
    Safety Issue?: No
• The IIEF EF domain score
  • Time Frame: At 4, 8, 12 weeks after start of study drug administration
    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)]
  • Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
    Safety Issue?: No
• 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
    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
  • Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF
    Safety Issue?: No
• Safety data
  • Time Frame: Throughout the study
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00678704

Study ID Number: 100607

ClinicalTrials.gov Identifier: NCT00678704

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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