Menopause Clinical Trial
Official title:
Ocular Impact of X Chromosome Karyotype and Sex Hormones in Turner Syndrome
Verified date | November 13, 2014 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | November 13, 2014 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
- INCLUSION CRITERIA: 1. Ability to understand and give informed consent. 2. Meet the diagnostic criteria for TS (45, X0) or premature ovarian failure OR age matched control for study participant with TS or POF. 3. For non Turner syndrome subjects only - Negative pregnancy test or post menopausal status for greater than or equal to 1 year. 4. Karyotype of XO for TS subjects or XX for POF and age matched control subjects. EXCLUSION CRITERIA: 1. Persons less than 18 years old. 2. Persons with ophthalmic diseases associated with ocular surface disease. 3. Hyperprolactinemia. 4. Cushing s syndrome. 5. Other endocrine disorders which impact sex steroid hormones. 6. AIDS 7. Pregnancy or lactation. 8. For age matched control population ONLY- complaints of dry eye. 9. 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstet Gynecol. 1986 Apr;67(4):604-6. — View Citation
Schaumberg DA, Buring JE, Sullivan DA, Dana MR. Hormone replacement therapy and dry eye syndrome. JAMA. 2001 Nov 7;286(17):2114-9. — View Citation
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. — View Citation
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