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

NCT00029159 | Completed Phase 3 DMC

• 1 other identifier: R01NS032531
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Turner Syndrome

Keywords

Turner syndrome; estrogen; androgen; growth hormone

Outcome Measures

Primary Outcomes (1)

• Cognitive function in girls with Turner Syndrome

  4 years

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: estrogen; Drug: androgen

2

PLACEBO COMPARATOR

Drug: estrogen; Other: placebo

Interventions

estrogen 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.

1; 2

androgen DRUG

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

1

placebo OTHER

an inactive substance

2

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

National Institutes of Health

Bethesda, Maryland, 20892, United States

Location

Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 726

Philadelphia, Pennsylvania, 19102, United States

Location

Related Publications (1)

• Zeger MP, Shah K, Kowal K, Cutler GB Jr, Kushner H, Ross JL. Prospective study confirms oxandrolone-associated improvement in height in growth hormone-treated adolescent girls with Turner syndrome. Horm Res Paediatr. 2011;75(1):38-46. doi: 10.1159/000317529. Epub 2010 Aug 20.

  PMID: 20733274 DERIVED

MeSH Terms

Conditions

Turner Syndrome

Interventions

Estrogens; Androgens

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Judith L. Ross, M.D.

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2002
• First Posted: January 9, 2002
• Study Start: November 1, 1992
• Primary Completion: January 1, 2007
• Study Completion: June 1, 2012
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

US (2)