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

Tracking Information

First Received Date ^ICMJE

April 1, 2008

Last Updated Date

June 19, 2009

Start Date ^ICMJE

January 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00678704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

BAY38-9456 - Pivotal Trial for Diabetes Patient

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Erectile Dysfunction
Diabetes Mellitus

Intervention ^ICMJE

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

Study Arm (s)

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)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

840

Completion Date

November 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Male

Ages

20 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00678704

Other Study ID Numbers ^ICMJE

100607

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Bayer HealthCare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

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

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