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

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 Intervention Phase
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Total score of the Tinnitus [ Time Frame: 4 times in 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 43
Study Start Date: October 2006
Study Completion Date: May 2007
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00666809

Berlin, Berlin / 285, Germany, 10117
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00666809     History of Changes
Other Study ID Numbers: 12049  2006-000463-29 
Study First Received: April 23, 2008
Last Updated: December 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Additional relevant MeSH terms:
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Vardenafil Dihydrochloride
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Vasodilator Agents processed this record on May 30, 2016