ProgesteroneNCT00264407
Neural Changes in the Aging Auditory System
An observational study of Progesterone and Estrogens, run by University of Rochester at 2 sites in United States.
Trial summary
The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women. Read more about this study
- Who is it for?
- Ages 60 to 86 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Progesterone, Estrogens, Hearing
- What is being tested?
- Hormone Replacement Therapy - HRT
- How many people
- 126 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2001to Feb 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 86 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy middle ears
Who cannot join
- 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
Show all 9Show fewer
- conductive hearing loss
- history of noise damage and/or audiograms signifying noise damage
- poor speech discrimination scores (80% or less)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
International Center Hearing & Speech Research - NTID - RIT
Rochester, New York, 14623-5604
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Age-Related Hearing Loss: Presbycusis & Its Neural Bases
The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.
Read the detailed description
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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- Conditions
- Progesterone, Estrogens, Hearing, Psychoacoustics, Auditory Perceptual Disorders
- Being tested
- Hormone Replacement Therapy - HRT
- Keywords
- Hearing Loss, Central, Presbycusis, Hearing Loss, Sensorineural, Hearing Loss, Cochlear, Hearing Loss, Bilateral, Sex Steroid Hormones, Estradiol
- Medical subject headings
- Auditory Perceptual Disorders, Hearing Loss, Central, Presbycusis, Hearing Loss, Sensorineural, Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone Replacement Therapy - HRTDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startJan 2001
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProgesteroneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 126 participants
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Rochester Institute of Technology, National Institute on Aging (NIA), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Investigators
- Robert D Frisina, Ph.D., Study director, University of Rochester Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264407
- Sponsor's protocol ID
- 10121
- Other IDs
- P01AG009524
- Status last verified
- Dec 2005
- First submitted
- 8 Dec 2005
- Last updated
- 12 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Related Hearing Loss: Presbycusis & Its Neural Bases
- ClinicalTrials.gov ID
- NCT00264407
- Acronym / sponsor ID
- 10121
- Conditions
- Progesterone, Estrogens, Hearing, Psychoacoustics, Auditory Perceptual Disorders
- Keywords
- Hearing Loss, Central, Presbycusis, Hearing Loss, Sensorineural, Hearing Loss, Cochlear, Hearing Loss, Bilateral, Sex Steroid Hormones, Estradiol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Rochester Institute of Technology, National Institute on Aging (NIA), National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jan 2001
- Study completion
- Feb 2005
- First posted
- 12 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.
Detailed description
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.
.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 60 to 86 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy middle ears
Key exclusion criteria (9 listed)
- ototoxic medications
- serious medical health problems
- neurological conditions
- Meniere's disease or labyrinthitis
- those who failed cognitive screening tests (Mini-Mental Test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormone Replacement Therapy - HRT | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D Frisina, Ph.D. study director
University of Rochester Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progesterone and Estrogens, run by University of Rochester at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2005.