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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-11-30

Study Completion Date

2012-06-30

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.

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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.

Conditions

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Turner Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

estrogen

Intervention Type DRUG

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.

androgen

Intervention Type DRUG

Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years

2

Group Type PLACEBO_COMPARATOR

estrogen

Intervention Type DRUG

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.

placebo

Intervention Type OTHER

an inactive substance

Interventions

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estrogen

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.

Intervention Type DRUG

androgen

Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years

Intervention Type DRUG

placebo

an inactive substance

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No