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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00666809 |
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.
Condition | Intervention | Phase |
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Tinnitus |
Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo |
Phase II |
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 |
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Arm 1: Active Comparator |
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 |
Drug: Placebo
Placebo BID p.o. for 12 weeks + 4 weeks follow-up
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Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bayer HealthCare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12049, EudraCT No: 2006-000463-29 |
Study First Received: | April 23, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00666809 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Vardenafil, Tinnitus |
Signs and Symptoms Sensation Disorders Hearing Disorders Vardenafil |
Otorhinolaryngologic Diseases Neurologic Manifestations Ear Diseases Tinnitus |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions |