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| Sponsored by: |
Bayer |
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00666809 |
Purpose
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 II |
| MedlinePlus related topics: | Tinnitus Toe Injuries and Disorders |
| ChemIDplus related topics: | Vardenafil |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study |
| Enrollment: | 40 |
| Study Start Date: | October 2006 |
| Study Completion Date: | May 2007 |
| Arms | Assigned Interventions |
|
Arm 1: Active Comparator
n/a
|
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
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Arm 2: Placebo Comparator
n/a
|
Drug: Placebo
Placebo BID p.o. for 12 weeks + 4 weeks follow-up
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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
| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | ( Bayer HealthCare AG, Therapeutic Area Head ) |
| Study ID Numbers: | 12049, EudraCT No: 2006-000463-29 |
| First Received: | April 23, 2008 |
| Last Updated: | May 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00666809 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
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