Vardenafil in Tinnitus

Study Overview
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Brief Summary
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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.

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

Conditions
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Tinnitus

Intervention / Treatment
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* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up<br>|
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Placebo BID p.o. for 12 weeks + 4 weeks follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total score of the Tinnitus |  | 4 times in 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram) |  | 16 weeks | 
| Quality of life (SF 36 Questionnaire) |  | 16 weeks | 
| Serum human chorionic Gonadotropin (hcG), pregnancy test |  | once at screening | 
| Safety and tolerability |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vardenafil,, Tinnitus