Vardenafil in Tinnitus

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00666809
First received: April 23, 2008
Last updated: November 6, 2008
Last verified: November 2008
  Purpose

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
Tinnitus
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: 40
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00666809

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

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00666809     History of Changes
Other Study ID Numbers: 12049, EudraCT No: 2006-000463-29
Study First Received: April 23, 2008
Last Updated: November 6, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Vardenafil,
Tinnitus

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014