Official Title: “Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy 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. The aim of the present trial is to evaluate this observation in more detail and to show efficacy of vardenafil superior over placebo in the treatment of chronic tinnitus.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
  • n/a
• Placebo Comparator: Arm 2
  • n/a

Primary Measures

• Total score of the Tinnitus Questionnaire after 12 weeks of treatment
  • Time Frame: 4 times in 16 weeks
    Safety Issue?: No

Secondary Measures

• Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
  • Time Frame: 16 weeks
    Safety Issue?: No
• Quality of life (SF 36 Questionnaire)
  • Time Frame: 16 weeks
    Safety Issue?: No
• Serum human chorionic Gonadotropin (hcG), pregnancy test
  • Time Frame: once at screening
    Safety Issue?: Yes
• Safety and tolerability
  • Time Frame: 16 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666809

Study ID Number: 12049

ClinicalTrials.gov Identifier: NCT00666809

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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