search
Back to results

Vardenafil in Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Vardenafil,, Tinnitus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Total score of the Tinnitus

Secondary Outcome Measures

Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
Quality of life (SF 36 Questionnaire)
Serum human chorionic Gonadotropin (hcG), pregnancy test
Safety and tolerability

Full Information

First Posted
April 23, 2008
Last Updated
December 8, 2014
Sponsor
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT00666809
Brief Title
Vardenafil in Tinnitus
Official Title
Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Vardenafil,, Tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Levitra (Vardenafil, BAY38-9456)
Intervention Description
Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo BID p.o. for 12 weeks + 4 weeks follow-up
Primary Outcome Measure Information:
Title
Total score of the Tinnitus
Time Frame
4 times in 16 weeks
Secondary Outcome Measure Information:
Title
Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
Time Frame
16 weeks
Title
Quality of life (SF 36 Questionnaire)
Time Frame
16 weeks
Title
Serum human chorionic Gonadotropin (hcG), pregnancy test
Time Frame
once at screening
Title
Safety and tolerability
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Berlin
State/Province
Berlin / 285
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrialsregister.eu
Description
click here and search for Bayer product information provided by the EMA

Learn more about this trial

Vardenafil in Tinnitus

We'll reach out to this number within 24 hrs