NCT00029159

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 10 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Turner Syndrome

Interventions

Type	Name	Description
DRUG	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.
DRUG	androgen	Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years
OTHER	placebo	an inactive substance

Timeline

• Start date: 1992-11-01
• Primary completion: 2007-01-01
• Completion: 2012-06-01
• First posted: 2002-01-09
• Last updated: 2012-06-05

Locations

2 sites across 1 country: United States