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

Thomas Jefferson University

Status and phase

Completed

Phase 3

Conditions

Turner Syndrome

Treatments

Drug: androgen

Drug: estrogen

Other: placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00029159

R01NS032531

Details and patient eligibility

About

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.

Full description

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.

Enrollment

200 patients

Sex

Female

Ages

10 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.