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Vardenafil in Tinnitus

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00666809
First received: April 23, 2008
Last updated: November 6, 2008
Last verified: November 2008
History of Changes

April 23, 2008
November 6, 2008
October 2006
 
Total score of the Tinnitus [ Time Frame: 4 times in 16 weeks ] [ Designated as safety issue: No ]
Total score of the Tinnitus Questionnaire after 12 weeks of treatment [ Time Frame: 4 times in 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00666809 on ClinicalTrials.gov Archive Site
  • Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Quality of life (SF 36 Questionnaire) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum human chorionic Gonadotropin (hcG), pregnancy test [ Time Frame: once at screening ] [ Designated as safety issue: Yes ]
  • Safety and tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
Vardenafil in Tinnitus
Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study

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.
 
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Tinnitus
  • Drug: Levitra (Vardenafil, BAY38-9456)
    Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
  • Drug: Placebo
    Placebo BID p.o. for 12 weeks + 4 weeks follow-up
  • Active Comparator: Arm 1
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2007
 

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00666809
12049, EudraCT No: 2006-000463-29
No
Therapeutic Area Head, Bayer HealthCare AG
Bayer
 
Study Director: Bayer Study Director Bayer
Bayer
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP