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Protocol Number:
93-CH-0054
- Title:
The Relative Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate, GH Binding Protein, IGF-I, and Cognitive Function in Growth Hormone-Treated Girls with Turner Syndrome
- Number:
93-CH-0054
- Summary:
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities.
This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination.
All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone.
The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.
- Sponsoring Institute:
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National Institute of Child Health and Human Development (NICHD)
- Recruitment Detail
- Type:
Active Accrual Of New Subjects
- Gender:
Female
- Referral Letter Required:
No
- Population Exclusion(s):
Male
- Eligibility Criteria:
INCLUSION CRITERIA
Girls with Turner syndrome will qualify to participate in this study if they meet the following criteria:
Karyotype diagnosis compatible with Turner syndrome.
No treatment with estrogen, androgen or growth hormone exceeding twelve months, and no treatment with either of these agents in the preceding 3 months.
Chronological age of 10.0 to 14.9 years.
Bone age less than or equal to 12 years.
EXCLUSION CRITERIA
Prior treatment with estrogen, androgen, or growth hormone for more than twelve months.
Y component in peripheral karyotype.
- Special Instructions:
Currently Not Provided
- Keywords:
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Turner's Syndrome
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Short Stature
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Cognitive Function
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Sex Steroids
- Recruitment Keywords:
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Turner's Syndrome
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Turner Syndrome
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TS
- Conditions:
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Dwarfism
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Turner's Syndrome
- Investigational Drug(s):
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Humatrope
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Oxandrolone
- Investigational Device(s):
- None
- Contacts:
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Patient Recruitment and Public Liaison Office
Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 Electronic Mail:prpl@mail.cc.nih.gov
- Citations:
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The Turner syndrome: cognitive deficits, affective discrimination, and behavior problems
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Cognitive development of unselected girls with complete and partial X monosomy
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Chromosomal and clinical findings in 100 females with Turner syndrome
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Warren Grant Magnuson Clinical Center (CC) National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/15/2004
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