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

Turner Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029159
• Other study ID #: R01NS032531
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2002
• Last updated: June 4, 2012
• Start date: November 1992
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2012
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 14 Years

Eligibility

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Syndrome
• Turner Syndrome

Intervention

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

Other:
• placebo
an inactive substance

Locations

Country	Name	City	State
United States	National Institutes of Health	Bethesda	Maryland
United States	Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 726	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function in girls with Turner Syndrome		4 years	Yes