Trial Condition(s):
Tinnitus
Vardenafil in tinnitus
Bayer Identifier:
12049
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Universitätsklinikum Charite zu Berlin Berlin, Germany, 10117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Evaluation of vardenafil for the treatment of subjective tinnitus: A controlled pilot study
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Total score of the TinnitusTimeframe: 4 times in 16 weeks
Secondary Outcome
- Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)Timeframe: 16 weeks
- Quality of life (SF 36 Questionnaire)Timeframe: 16 weeks
- Serum human chorionic Gonadotropin (hcG), pregnancy testTimeframe: once at screening
- Safety and tolerabilityTimeframe: 16 weeks
Additional Information
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