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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Page 1 of 1 (1 locations)

1

Berlin, Berlin / 285, Germany, 10117