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| Sponsor: | University of Rochester |
|---|---|
| Collaborators: |
Rochester Institute of Technology National Institute on Aging (NIA) National Institute on Deafness and Other Communication Disorders (NIDCD) |
| Information provided by: | University of Rochester |
| ClinicalTrials.gov Identifier: | NCT00264407 |
Purpose
The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.
| Condition | Intervention | Phase |
|---|---|---|
|
Progesterone Estrogens Hearing Psychoacoustics Auditory Perceptual Disorders |
Drug: Hormone Replacement Therapy - HRT |
Phase I |
| Study Type: | Observational |
| Study Design: | Natural History, Cross-Sectional, Case Control, Retrospective Study |
| Official Title: | Age-Related Hearing Loss: Presbycusis & Its Neural Bases |
| Estimated Enrollment: | 126 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | February 2005 |
Background: Female hormone influences on the development and aging of the auditory system are not completely understood. The present study retrospectively analyzed and compared hearing abilities among post-menopausal women taking hormone replacement therapy (HRT), treated with estrogen and progesterone (E+P); estrogen alone (E), and a third (control - NHRT) group, matched for age, who did not receive any HRT.
Methods: 126 subjects, (60-86 yr), N=32, E+P; N=31, E; N= 63, NHRT; matched for age and health status participated. All had relatively healthy medical histories, absence of significant noise exposure, middle ear problems, major surgeries or current/heavy smoking. Hearing tests included pure tone audiometry (PTA), tympanometry, distortion-product otoacoustic emissions (DPOAEs), transient otoacoustic emissions (TEOAEs) and hearing-in-noise-test (HINT). The latter is a test for speech perception in background noise: the major complaint of hearing-impaired persons.
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Eligibility| Ages Eligible for Study: | 60 Years to 86 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| International Center Hearing & Speech Research - NTID - RIT | |
| Rochester, New York, United States, 14623-5604 | |
| Study Director: | Robert D Frisina, Ph.D. | University of Rochester Medical School |
More Information
| Study ID Numbers: | 10121, P01 AG09524 |
| Study First Received: | December 8, 2005 |
| Last Updated: | December 8, 2005 |
| ClinicalTrials.gov Identifier: | NCT00264407 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hearing Loss, Central Presbycusis Hearing Loss, Sensorineural Hearing Loss, Cochlear |
Hearing Loss, Bilateral Sex Steroid Hormones Estradiol |
|
Sensation Disorders Otorhinolaryngologic Diseases Physiological Effects of Drugs Retrocochlear Diseases Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Central Nervous System Diseases Brain Diseases Hormones Ear Diseases Pharmacologic Actions |
Cognition Disorders Auditory Diseases, Central Signs and Symptoms Hearing Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Auditory Perceptual Disorders Mental Disorders Neurologic Manifestations Hearing Loss Neurobehavioral Manifestations Perceptual Disorders |
