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Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT00660998
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : December 11, 2014
Sponsor:
Information provided by:
Bayer

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : February 2003
Actual Study Completion Date : January 2004


Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 1h before sexual intercourse

Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ]
  2. Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. International Index of Erectile Function - Erectile Function Domain [ Time Frame: 12 weeks ]
  2. Safety and Tolerability [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660998


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

Additional Information:
Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00660998     History of Changes
Other Study ID Numbers: 100540
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Erectile dysfunction
Diabetes mellitus type 1
Vardenafil

Additional relevant MeSH terms:
Erectile Dysfunction
Diabetes Mellitus, Type 1
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents