Vardenafil in Tinnitus

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 23, 2008
Last updated: December 8, 2014
Last verified: December 2014

April 23, 2008
December 8, 2014
October 2006
Not Provided
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 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
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
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • 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 Identifier (NCT Number) in Medline.
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
18 Years to 64 Years
Contact information is only displayed when the study is recruiting subjects
12049, 2006-000463-29
Not Provided
Study Director: Bayer Study Director Bayer
December 2014

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