Vardenafil in Tinnitus

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00666809

Enrollment

Registered

2008-04-25

Start date

2006-10-31

Completion date

2007-05-31

Last updated

2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Keywords

Vardenafil,, Tinnitus

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.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

Vardenafil 10 mg BID p.o. for 12 weeks + 4 weeks follow-up

DRUGPlacebo

Placebo BID p.o. for 12 weeks + 4 weeks follow-up

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
Total score of the Tinnitus	4 times in 16 weeks

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026