Vardenafil in Tinnitus - Full Text View

Purpose

Randomized, parallel-group, double-blind, placebo-controlled trial over 16 weeks (12 weeks of treatment + 4 weeks follow-up) with 10 mg vardenafil BID p.o. in men and women with chronic tinnitus.

Condition	Intervention	Phase
Tinnitus	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase II

MedlinePlus related topics:

Tinnitus Toe Injuries and Disorders

ChemIDplus related topics:

Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study

Further study details as provided by Bayer:

Primary Outcome Measures:

Total score of the Tinnitus Questionnaire after 12 weeks of treatment [ Time Frame: 4 times in 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Quality of life (SF 36 Questionnaire) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Serum human chorionic Gonadotropin (hcG), pregnancy test [ Time Frame: once at screening ] [ Designated as safety issue: Yes ]
Safety and tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	October 2006
Study Completion Date:	May 2007

Arms	Assigned Interventions
Arm 1: Active Comparator n/a	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
Arm 2: Placebo Comparator n/a	Drug: Placebo Placebo BID p.o. for 12 weeks + 4 weeks follow-up

Detailed Description:

There is incidental evidence (casuistic findings) that the treatment with vardenafil of male patients suffering from erectile dysfunction and comorbid tinnitus experienced an improvement of their tinnitus. The aim of the present trial is to evaluate this observation in more detail and to show efficacy of vardenafil superior over placebo in the treatment of chronic tinnitus.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic subjective cochlear tinnitus
No treatment of tinnitus within 4 weeks prior to study entry
Duration of tinnitus > 3 months

Exclusion Criteria:

Acute tinnitus
Intermittent tinnitus
History of M. Menieré
History of conductive deafness
History of psychogenic deafness
History of tumors of the middle ear, inner ear or cerebella-pontine angle (malignant and non malignant)
Patients diagnosed of multiple sclerosis
History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
Nitrates or nitric oxide donors
Any other concurrent treatment of tinnitus during study
pregnant and breast-feeding women
women with child-bearing potential not using adequate birth control method (Note: as adequate method of birth control oral contraception, spiral or sexual abstinence is recommended)
Other exclusion criteria apply according to the Summary of Product Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666809

Locations


Germany, Berlin / 285

	Berlin, Berlin / 285, Germany, 10117

Sponsors and Collaborators

Bayer

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	( Bayer HealthCare AG, Therapeutic Area Head )
Study ID Numbers:	12049, EudraCT No: 2006-000463-29
First Received:	April 23, 2008
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00666809
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Bayer:

Vardenafil,

Tinnitus

Study placed in the following topic categories:

Signs and Symptoms

Sensation Disorders

Hearing Disorders

Vardenafil

Otorhinolaryngologic Diseases

Neurologic Manifestations

Ear Diseases

Tinnitus

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors

Molecular Mechanisms of Pharmacological Action

Nervous System Diseases

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00666809