check_circleStudy Completed

Tinnitus

Bayer Identifier:

12049

ClinicalTrials.gov Identifier:

NCT00666809

EudraCT Number:

2006-000463-29

EU CT Number:

Not Available
Vardenafil in tinnitus

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 64 Years
  • - Chronic subjective cochlear tinnitus
    - No treatment of tinnitus within 4 weeks prior to study entry
    - Duration of tinnitus > 3 months
  • - 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

Trial summary

Enrollment Goal
43
Trial Dates
October 2006 - May 2007
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Universitätsklinikum Charite zu BerlinBerlin, 10117, Germany

Primary Outcome

  • Total score of the Tinnitus
    date_rangeTime Frame:
    4 times in 16 weeks
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    Safety Issue:
    no

Secondary Outcome

  • Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Quality of life (SF 36 Questionnaire)
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Serum human chorionic Gonadotropin (hcG), pregnancy test
    date_rangeTime Frame:
    once at screening
    enhanced_encryption
    Safety Issue:
    yes
  • Safety and tolerability
    date_rangeTime Frame:
    16 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Evaluation of vardenafil for the treatment of subjective tinnitus: A controlled pilot study
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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