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Vardenafil in Tinnitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666809
First Posted: April 25, 2008
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
April 23, 2008
April 25, 2008
December 9, 2014
October 2006
Not Provided
Total score of the Tinnitus [ Time Frame: 4 times in 16 weeks ]
Total score of the Tinnitus Questionnaire after 12 weeks of treatment [ Time Frame: 4 times in 16 weeks ]
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 ]
  • Quality of life (SF 36 Questionnaire) [ Time Frame: 16 weeks ]
  • Serum human chorionic Gonadotropin (hcG), pregnancy test [ Time Frame: once at screening ]
  • Safety and tolerability [ Time Frame: 16 weeks ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
May 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00666809
12049
2006-000463-29 ( EudraCT Number )
No
Not Provided
Not Provided
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
December 2014

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