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BAY38-9456 - Pivotal Trial for Diabetes Patient

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00678704
First received: April 1, 2008
Last updated: June 19, 2009
Last verified: June 2009
History of Changes
  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.


Condition Intervention Phase
Erectile Dysfunction
Diabetes Mellitus
 Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 840
Study Start Date: January 2004
Study Completion Date: November 2004
Arms Assigned Interventions
Placebo Comparator: Arm 3 Drug: Placebo
Placebo tablet prior to intercourse on demand
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 10 mg tablet prior to intercourse on demand
Experimental: Arm 2 Drug: Levitra (Vardenafil, BAY38-9456)
BAY 38-9456 20 mg tablet prior to intercourse on demand

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678704

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00678704     History of Changes
Other Study ID Numbers: 100607
Study First Received: April 1, 2008
Last Updated: June 19, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Vardenafil
PDE5 inhibitor
Erectile Dysfunction
Diabetes Mellitus
Sexual Dysfunction

Additional relevant MeSH terms:
Diabetes Mellitus
Erectile Dysfunction
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
 Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013