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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: | Observational Model: Case Control Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Retrospective |
| 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.
.
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
| ClinicalTrials.gov Identifier: | NCT00264407 History of Changes |
| Other Study ID Numbers: | 10121, P01 AG09524 |
| Study First Received: | December 8, 2005 |
| Last Updated: | December 8, 2005 |
| 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 |
|
Auditory Perceptual Disorders Hearing Loss Perceptual Disorders Presbycusis Auditory Diseases, Central Retrocochlear Diseases Ear Diseases Otorhinolaryngologic Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurobehavioral Manifestations |
Neurologic Manifestations Signs and Symptoms Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Hearing Disorders Sensation Disorders Hearing Loss, Sensorineural Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
