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.
- Chronic subjective cochlear tinnitus - No treatment of tinnitus within 4 weeks prior to study entry - Duration of tinnitus > 3 months
- 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
Universitätsklinikum Charite zu Berlin
Berlin, Germany, 10117
E-mail: [email protected]
Phone: Not Available
Evaluation of vardenafil for the treatment of subjective tinnitus: A controlled pilot study