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The effect of androgen and growth hormone on height and learning in girls with Turner syndrome - Article


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Devic's Syndrome

Devic/'s Disease; Devic//'s Disease; neuromyelitis


Clinical Trial: The effect of androgen and growth hormone on height and learning in girls with Turner syndrome

This study is no longer recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purposes of this study are to learn whether treatment with an androgen type hormone will improve the visual-spatial problems associated with Turner syndrome, and to evaluate the effect growth hormone, with and without androgen, has on growth.

Condition Treatment or Intervention Phase
Turner Syndrome
 Drug: estrogen
 Drug: androgen
Phase III

MedlinePlus related topics:  Turner's Syndrome
Genetics Home Reference related topics:  Turner syndrome

Study Type: Interventional
Study Design: Treatment, Randomized

Official Title: The effects of androgen, estrogen, and the combination of androgen and estrogen on growth rate and cognitive function of growth hormone-treated girls with Turner syndrome

Further Study Details: 

Expected Total Enrollment:  200

Study start: November 1992

Turner syndrome is associated with short stature, multiple physical stigmata, absent pubertal development, and increased learning problems. This study is designed to (1) examine the effects of sex steroids (androgen and estrogen) on multiple variables including growth rate, GH binding protein, IGF-I, IGFBP3, and cognitive function in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination versus each alone, on the above variables.

Eligibility

Ages Eligible for Study:  10 Years   -   14 Years,  Genders Eligible for Study:  Female

Criteria

  • Karyotype diagnosis compatible with Turner syndrome, but no presence of any Y material in the peripheral karyotype unless a gonadectomy has been performed;
  • Chronological age between 10.0 and 14.9 years;
  • Bone age less than or equal to 12 years; and
  • No treatment with estrogen, androgen, growth hormone, or any other growth-promoting agents exceeding 12 months, and no treatment with any of these agents in the previous 3 months.

Location Information


Maryland
      National Institutes of Health, Bethesda,  Maryland,  20892,  United States

Pennsylvania
      Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 726, Philadelphia,  Pennsylvania,  19102,  United States

Study chairs or principal investigators

Judith L. Ross, M.D.,  Principal Investigator,  Thomas Jefferson University Hospital   

More Information

Study ID Numbers:  R01NS32531
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  January 8, 2002
ClinicalTrials.gov Identifier:  NCT00029159
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 11, 2008



Page Updated: September 6, 2005
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