Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00660998

Purpose

Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Rand, db, Parallel-Group, Plac-Controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-Dose Regimen Compared to Plac in Men With Diabetes Mellitus Type 1 and Erectile Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1 Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

International Index of Erectile Function - Erectile Function Domain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	355
Study Start Date:	February 2003
Study Completion Date:	January 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 5mg, 10mg or 20mg taken 1h before sexual intercourse
Arm 2: Placebo Comparator	Drug: Placebo Matching placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
Diabetes type 1
Stable sexual relationship for > 6 month.

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
Nitrate therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660998

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	100540
Study First Received:	April 15, 2008
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00660998 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Erectile dysfunction
Diabetes mellitus type 1
Vardenafil

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Metabolic Diseases
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Diabetes Mellitus
Endocrine System Diseases
Enzyme Inhibitors
Genital Diseases, Male

Sexual and Gender Disorders
Pharmacologic Actions
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Diabetes Mellitus, Type 1
Mental Disorders
Glucose Metabolism Disorders
Erectile Dysfunction

ClinicalTrials.gov processed this record on February 08, 2010