Fludrocortisone for Sudden Hearing Loss

Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01186185

Enrollment

Registered

2010-08-23

Start date

2012-08-31

Completion date

2016-03-31

Last updated

2019-10-18

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

Conditions

Hearing Loss, Sensorineural

Keywords

sudden, sensorineural, hearing loss, fludrocortisone, mineralocorticoid, steroid

Brief summary

The standard of care treatment of sudden hearing loss uses a type of steroid called glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.

Interventions

DRUGFludrocortisone

Fludrocortisone 0.2 mg by mouth daily for 30 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

* Age 18 or older * Idiopathic sudden sensorineural hearing loss within 3 months * Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid

Exclusion criteria

* Other diagnosis for the sudden hearing loss * Concurrent systemic use of another steroid * Hypersensitivity to fludrocortisone * Systemic fungal infection * Hypertension requiring two or more medications * Pitting edema * Cardiomegaly * Congestive heart failure * Electrolyte abnormality * Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine

Design outcomes

Primary

Measure	Time frame	Description
Hearing	At one month	Hearing outcome will be determine by pure-tone and speech audiometry measured at the completion of a one-month course of treatment and compared with pre-treatment test results.

Countries

United States

Outcome results

None listed

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