- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00666809
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Berlin / 285
-
Berlin, Berlin / 285, Germany, 10117
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Arm 2
|
Placebo BID p.o. for 12 weeks + 4 weeks follow-up
|
Active Comparator: Arm 1
|
Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total score of the Tinnitus
Time Frame: 4 times in 16 weeks
|
4 times in 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
Time Frame: 16 weeks
|
16 weeks
|
Quality of life (SF 36 Questionnaire)
Time Frame: 16 weeks
|
16 weeks
|
Serum human chorionic Gonadotropin (hcG), pregnancy test
Time Frame: once at screening
|
once at screening
|
Safety and tolerability
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Ear Diseases
- Sensation Disorders
- Hearing Disorders
- Tinnitus
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Vardenafil Dihydrochloride
Other Study ID Numbers
- 12049 (Other Identifier: Division of AIDS (DAIDS-ES))
- 2006-000463-29 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of ZurichCompletedTinnitus, SubjectiveGermany, Switzerland
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