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

Thomas Jefferson University2 sites in 1 country200 target enrollmentNovember 1992

ConditionsTurner Syndrome

Interventionsestrogen androgen placebo

Drugsestrogen androgen

Overview

Phase: Phase 3
Intervention: estrogen
Conditions: Turner Syndrome
Sponsor: Thomas Jefferson University
Enrollment: 200
Locations: 2
Primary Endpoint: Cognitive function in girls with Turner Syndrome
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 1992

End Date

June 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel