Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure

Menopause Clinical Trial

Official title:

Ocular Impact of X Chromosome Karyotype and Sex Hormones in Turner Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471731
• Other study ID #: 070145
• Secondary ID: 07-EI-0145
• Status: Completed
• Phase: N/A
• First received: May 9, 2007
• Last updated: February 13, 2018
• Start date: May 7, 2007
• Est. completion date: November 13, 2014

Study information

• Verified date: November 13, 2014
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 13, 2014
• 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.

Related Conditions & MeSH terms

• Chromosome Aberrations
• Chromosome Disorders
• Gonadal Dysgenesis
• Menopause
• Menopause, Premature
• Ovarian Failure, Premature
• Perimenopause
• Premature Birth
• Primary Ovarian Insufficiency
• Sex Chromosome Aberrations
• Syndrome
• Turner Syndrome

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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