Vardenafil in Tinnitus

Bayer

Status and phase

Completed

Phase 2

Conditions

Tinnitus

Treatments

Drug: Levitra (Vardenafil, BAY38-9456)

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00666809

2006-000463-29 (EudraCT Number)

12049

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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