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.

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