Vardenafil in Tinnitus - Full Text View

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

Purpose

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.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Total score of the Tinnitus [ 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	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
Arm 2: Placebo Comparator	Drug: Placebo Placebo BID p.o. for 12 weeks + 4 weeks follow-up

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

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

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	12049, EudraCT No: 2006-000463-29
Study First Received:	April 23, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00666809 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Vardenafil,
Tinnitus

Additional relevant MeSH terms:

Sensation Disorders
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Enzyme Inhibitors
Tinnitus
Ear Diseases

Pharmacologic Actions
Signs and Symptoms
Hearing Disorders
Vardenafil
Phosphodiesterase Inhibitors
Neurologic Manifestations

ClinicalTrials.gov processed this record on November 25, 2009