Turner SyndromeNCT00471731
Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure
An observational study of Turner Syndrome and Ovarian Failure, Premature, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Premature ovarian failure (POF) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Turner Syndrome, Ovarian Failure, Premature, Sex Chromosome Aberrations
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2007to 13 Nov 2014
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to understand and give informed consent.
- Meet the diagnostic criteria for TS (45, X0) or premature ovarian failure OR age matched control for study participant with TS or POF.
- For non Turner syndrome subjects only - Negative pregnancy test or post menopausal status for greater than or equal to 1 year.
- Karyotype of XO for TS subjects or XX for POF and age matched control subjects.
Who cannot join
- Persons less than 18 years old.
- Persons with ophthalmic diseases associated with ocular surface disease.
- Hyperprolactinemia.
- Cushing s syndrome.
- Other endocrine disorders which impact sex steroid hormones.
- AIDS
Show all 9Show fewer
- Pregnancy or lactation.
- For age matched control population ONLY- complaints of dry eye.
- For age matched control population ONLY- oral contraceptives or menopausal hormone therapy or any medications which alter sex hormone levels in the blood or chronic usage of medications that induce dry eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Ocular Impact of X Chromosome Karyotype and Sex Hormones in Turner Syndrome
Premature ovarian failure (POF) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. From preliminary data, we suspect that women with Turners syndrome (45, XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. Comparing POF and TS women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by POF and TS.
Read the detailed description
Premature ovarian failure (POF) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. From preliminary data, we suspect that women with Turners syndrome (45, XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. Comparing POF and TS women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by POF and TS.
- Conditions
- Turner Syndrome, Ovarian Failure, Premature, Sex Chromosome Aberrations, Menopause, Perimenopause
- Keywords
- Ocular Surface Disease, Imprinting, Eye Abnormalities, Ovarian Insufficiency, Women's Eye Health and Disease, Turner Syndrome, TS, Premature Ovarian Failure, POF, Healthy Volunteer, HV
- Medical subject headings
- Turner Syndrome, Primary Ovarian Insufficiency, Sex Chromosome Aberrations, Eye Abnormalities, Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2007 (estimated)
- Study start7 May 2007
- Study completion13 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Turner SyndromeStudies 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
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Janine A Clayton, M.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471731
- Sponsor's protocol ID
- 070145
- Other IDs
- 07-EI-0145
- Status last verified
- 13 Nov 2014
- First submitted
- 9 May 2007
- Last updated
- 14 Feb 2018
- Results posted
- No
Publications
Smith JA, Vitale S, Reed GF, Grieshaber SA, Goodman LA, Vanderhoof VH, Calis KA, Nelson LM. Dry eye signs and symptoms in women with premature ovarian failure. Arch Ophthalmol. 2004 Feb;122(2):151-6. doi: 10.1001/archopht.122.2.151.
PubMed 14769589Schaumberg DA, Buring JE, Sullivan DA, Dana MR. Hormone replacement therapy and dry eye syndrome. JAMA. 2001 Nov 7;286(17):2114-9. doi: 10.1001/jama.286.17.2114.
PubMed 11694152Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.
PubMed 3960433
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Impact of X Chromosome Karyotype and Sex Hormones in Turner Syndrome
- ClinicalTrials.gov ID
- NCT00471731
- Acronym / sponsor ID
- 070145
- Conditions
- Turner Syndrome, Ovarian Failure, Premature, Sex Chromosome Aberrations, Menopause, Perimenopause
- Keywords
- Ocular Surface Disease, Imprinting, Eye Abnormalities, Ovarian Insufficiency, Women's Eye Health and Disease, Turner Syndrome, TS, Premature Ovarian Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 7 May 2007
- Study completion
- 13 Nov 2014
- First posted
- 10 May 2007 (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.
Premature ovarian failure (POF) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. From preliminary data, we suspect that women with Turners syndrome (45, XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. Comparing POF and TS women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by POF and TS.
Detailed description
Premature ovarian failure (POF) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. From preliminary data, we suspect that women with Turners syndrome (45, XO), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. Comparing POF and TS women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by POF and TS.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (9 listed)
- Persons less than 18 years old.
- Persons with ophthalmic diseases associated with ocular surface disease.
- Hyperprolactinemia.
- Cushing s syndrome.
- Other endocrine disorders which impact sex steroid hormones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 14 Feb 2018.
- Background: PubMed 14769589Smith JA, Vitale S, Reed GF, Grieshaber SA, Goodman LA, Vanderhoof VH, Calis KA, Nelson LM. Dry eye signs and symptoms in women with premature ovarian failure. Arch Ophthalmol. 2004 Feb;122(2):151-6. doi: 10.1001/archopht.122.2.151.
- Background: PubMed 11694152Schaumberg DA, Buring JE, Sullivan DA, Dana MR. Hormone replacement therapy and dry eye syndrome. JAMA. 2001 Nov 7;286(17):2114-9. doi: 10.1001/jama.286.17.2114.
- Background: PubMed 3960433Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6.
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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.
Janine A Clayton, M.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Turner Syndrome and Ovarian Failure, Premature, run by National Eye Institute (NEI) at 1 site 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 4 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
On the ClinicalTrials.gov record for NCT00471731, which also lists 3 linked publications.
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 14 Feb 2018.