TinnitusPhase 2NCT00666809
Vardenafil in Tinnitus
A Phase 2 study testing Levitra (Vardenafil, BAY38-9456) in people with Tinnitus, run by Bayer at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Levitra (Vardenafil, BAY38-9456)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2006to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic subjective cochlear tinnitus
- No treatment of tinnitus within 4 weeks prior to study entry
- Duration of tinnitus > 3 months
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study
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.
- Conditions
- Tinnitus
- Being tested
- Levitra (Vardenafil, BAY38-9456), Placebo
- Keywords
- Vardenafil,, Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levitra (Vardenafil, BAY38-9456)Drug
Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up
PlaceboDrug
Placebo BID p.o. for 12 weeks + 4 weeks follow-up
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score of the Tinnitus
Measured: 4 times in 16 weeks
Secondary outcomes (4)
Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
Measured: 16 weeks
Quality of life (SF 36 Questionnaire)
Measured: 16 weeks
Serum human chorionic Gonadotropin (hcG), pregnancy test
Measured: once at screening
Safety and tolerability
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startOct 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666809
- Sponsor's protocol ID
- 12049
- Other IDs
- 2006-000463-29
- Status last verified
- Dec 2014
- First submitted
- 23 Apr 2008
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vardenafil for the Treatment of Subjective Tinnitus: A Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT00666809
- Acronym / sponsor ID
- 12049
- Conditions
- Tinnitus
- Keywords
- Vardenafil,, Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- May 2007 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Levitra (Vardenafil, BAY38-9456) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic subjective cochlear tinnitus
- No treatment of tinnitus within 4 weeks prior to study entry
- Duration of tinnitus > 3 months
Key exclusion criteria (13 listed)
- Acute tinnitus
- Intermittent tinnitus
- History of M. Menieré
- History of conductive deafness
- History of psychogenic deafness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levitra (Vardenafil, BAY38-9456)Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up | Drug | Arm 1 |
| PlaceboPlacebo BID p.o. for 12 weeks + 4 weeks follow-up | Drug | Arm 2 |
Primary outcome
Total score of the Tinnitus
Time frame: 4 times in 16 weeks
4 secondary outcomes
Audiometric measurements (mode, frequency and loudness of tinnitus, pure tone audiogram, speech audiogram)
Time frame: 16 weeks
Quality of life (SF 36 Questionnaire)
Time frame: 16 weeks
Serum human chorionic Gonadotropin (hcG), pregnancy test
Time frame: once at screening
Safety and tolerability
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- click here and search for Bayer product information provided by the EMALink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levitra (Vardenafil, BAY38-9456) in people with Tinnitus, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score of the Tinnitus (time frame: 4 times in 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.