Vardenafil in Tinnitus

Phase 2

Completed

• Conditions: Tinnitus
• Interventions: Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo

• Registration Number: NCT00666809
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study Completion: 2007-05
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Levitra (Vardenafil, BAY38-9456)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Total score of the Tinnitus	4 times in 16 weeks

Secondary Outcome Measures

Name	Time	Method
Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)	16 weeks
Quality of life (SF 36 Questionnaire)	16 weeks
Serum human chorionic Gonadotropin (hcG), pregnancy test	once at screening
Safety and tolerability	16 weeks