Vardenafil in Tinnitus

Tinnitus Clinical Trial

Official title:

Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666809
• Other study ID #: 12049
• Secondary ID: 2006-000463-29
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2008
• Last updated: December 8, 2014
• Start date: October 2006
• Est. completion date: May 2007

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
• Placebo
Placebo BID p.o. for 12 weeks + 4 weeks follow-up

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score of the Tinnitus		4 times in 16 weeks	No
Secondary	Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)		16 weeks	No
Secondary	Quality of life (SF 36 Questionnaire)		16 weeks	No
Secondary	Serum human chorionic Gonadotropin (hcG), pregnancy test		once at screening	Yes
Secondary	Safety and tolerability		16 weeks	Yes

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