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...
Date First Received: April 23, 2008
Last Updated: November 6, 2008
Verified by: Bayer, November 2008
Clinical Trial Phase: Phase 2 | Start Date: October 2006
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
Official Title: “Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study”
Condition Keyword(s):
Intervention(s):
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 Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Levitra (Vardenafil, BAY38-9456)
- Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
- Drug: Placebo
- Placebo BID p.o. for 12 weeks + 4 weeks follow-up
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Arm 1
- Placebo Comparator: Arm 2
Outcome Measures for this Clinical Trial
Primary Measures
- Total score of the Tinnitus
- Time Frame: 4 times in 16 weeks
Safety Issue?: No
- Time Frame: 4 times in 16 weeks
Secondary Measures
- Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
- Time Frame: 16 weeks
Safety Issue?: No
- Time Frame: 16 weeks
- Quality of life (SF 36 Questionnaire)
- Time Frame: 16 weeks
Safety Issue?: No
- Time Frame: 16 weeks
- Serum human chorionic Gonadotropin (hcG), pregnancy test
- Time Frame: once at screening
Safety Issue?: Yes
- Time Frame: once at screening
- Safety and tolerability
- Time Frame: 16 weeks
Safety Issue?: Yes
- Time Frame: 16 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 64 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bayer
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00666809
Study ID Number: 12049
ClinicalTrials.gov Identifier: NCT00666809
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
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