NCT00264407

Brief Summary

The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
Last Updated

December 12, 2005

Status Verified

December 1, 2005

First QC Date

December 8, 2005

Last Update Submit

December 8, 2005

Conditions

ProgesteroneEstrogensHearingPsychoacousticsAuditory Perceptual Disorders

Keywords

Hearing Loss, CentralPresbycusisHearing Loss, SensorineuralHearing Loss, CochlearHearing Loss, BilateralSex Steroid HormonesEstradiol

Interventions

Hormone Replacement Therapy - HRTDRUG

Eligibility Criteria

Age60 Years - 86 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy middle ears

You may not qualify if:

  • ototoxic medications
  • serious medical health problems
  • neurological conditions
  • Meniere's disease or labyrinthitis
  • those who failed cognitive screening tests (Mini-Mental Test)
  • current/heavy smokers
  • conductive hearing loss
  • history of noise damage and/or audiograms signifying noise damage
  • poor speech discrimination scores (80% or less)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Center Hearing & Speech Research - NTID - RIT

Rochester, New York, 14623-5604, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Auditory Perceptual DisordersHearing Loss, CentralPresbycusisHearing Loss, SensorineuralHearing Loss, Bilateral

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Auditory Diseases, CentralRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersHearing LossHearing DisordersSensation Disorders

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Robert D Frisina, Ph.D.

    University of Rochester Medical School

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 8, 2005

First Posted

December 12, 2005

Study Start

January 1, 2001

Study Completion

February 1, 2005

Last Updated

December 12, 2005

Record last verified: 2005-12

Locations

US(2)