Vardenafil in Tinnitus

Bayer43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tinnitus

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up

PlaceboDRUG

Placebo BID p.o. for 12 weeks + 4 weeks follow-up

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Berlin, Berlin / 285, Germany

Outcomes

Primary Outcomes

Total score of the Tinnitus

Time frame: 4 times in 16 weeks

Secondary Outcomes

Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)

Time frame: 16 weeks

Quality of life (SF 36 Questionnaire)

Time frame: 16 weeks

Serum human chorionic Gonadotropin (hcG), pregnancy test

Time frame: once at screening

Safety and tolerability

Time frame: 16 weeks

Data from ClinicalTrials.gov

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