Vardenafil in Tinnitus
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tinnitus
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
Official title: Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Total score of the Tinnitus Questionnaire after 12 weeks of treatment
Secondary outcome: Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)Quality of life (SF 36 Questionnaire) Serum human chorionic Gonadotropin (hcG), pregnancy test Safety and tolerability
Detailed description:
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. The aim of the present trial is to evaluate this observation in more
detail and to show efficacy of vardenafil superior over placebo in the treatment of chronic
tinnitus.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
Berlin, Berlin / 285 10117, Germany
Additional Information
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Starting date: October 2006
Ending date: May 2007
Last updated: May 21, 2008
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