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Vardenafil in Tinnitus

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ClinicalTrials.gov Identifier: NCT00666809
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : December 9, 2014
Information provided by (Responsible Party):

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 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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study
Study Start Date : October 2006
Actual Study Completion Date : May 2007

Arm Intervention/treatment
Active Comparator: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up

Placebo Comparator: Arm 2 Drug: Placebo
Placebo BID p.o. for 12 weeks + 4 weeks follow-up

Primary Outcome Measures :
  1. Total score of the Tinnitus [ Time Frame: 4 times in 16 weeks ]

Secondary Outcome Measures :
  1. Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram) [ Time Frame: 16 weeks ]
  2. Quality of life (SF 36 Questionnaire) [ Time Frame: 16 weeks ]
  3. Serum human chorionic Gonadotropin (hcG), pregnancy test [ Time Frame: once at screening ]
  4. Safety and tolerability [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666809

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Berlin, Berlin / 285, Germany, 10117
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00666809    
Other Study ID Numbers: 12049
2006-000463-29 ( EudraCT Number )
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents