BAY38-9456 - Pivotal Trial for Diabetes Patient

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00678704
First received: April 1, 2008
Last updated: October 12, 2013
Last verified: October 2013

April 1, 2008
October 12, 2013
January 2004
Not Provided
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00678704 on ClinicalTrials.gov Archive Site
  • The Global Assessment Question [ Time Frame: At 4, 8, 12 weeks after start of study drug administration and LOCF ] [ Designated as safety issue: No ]
  • The IIEF EF domain score [ Time Frame: At 4, 8, 12 weeks after start of study drug administration ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Safety data [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
BAY38-9456 - Pivotal Trial for Diabetes Patient
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Erectile Dysfunction
  • Diabetes Mellitus
  • 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
  • Placebo Comparator: Arm 3
    Intervention: Drug: Placebo
  • Experimental: Arm 1
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Experimental: Arm 2
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
840
November 2004
Not Provided

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
Male
20 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00678704
100607
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP