The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Turner Syndrome

Intervention / Treatment
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* Drug: estrogen
* Drug: androgen
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: estrogen<br>* Participants were started on ethinyl estradiol at a daily dose of 50ng/kg at the beginning of the 3rd year of the study. The estrogen was continued until study end.<br>Drug: androgen<br>* Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years<br>|
| Placebo Comparator: 2<br> | Drug: estrogen<br>* Participants were started on ethinyl estradiol at a daily dose of 50ng/kg at the beginning of the 3rd year of the study. The estrogen was continued until study end.<br>Other: placebo<br>* an inactive substance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function in girls with Turner Syndrome |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Turner syndrome, estrogen, androgen, growth hormone