Status:
COMPLETED
Vardenafil in Tinnitus
Lead Sponsor:
Bayer
Conditions:
Tinnitus
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
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 tinn...
Eligibility Criteria
Inclusion
- Chronic subjective cochlear tinnitus
- No treatment of tinnitus within 4 weeks prior to study entry
- Duration of tinnitus \> 3 months
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00666809
Start Date
October 1 2006
End Date
May 1 2007
Last Update
December 9 2014
Active Locations (1)
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1
Berlin, Berlin / 285, Germany, 10117