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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00029159
First received: January 8, 2002
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Turner Syndrome
Drug: estrogen
Drug: androgen
Other: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Cognitive function in girls with Turner Syndrome [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: November 1992
Study Completion Date: June 2012
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 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
Placebo Comparator: 2 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.
Other: placebo
an inactive substance

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.

  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029159

Locations
United States, Maryland
National Institutes of Health
Bethesda, Maryland, United States, 20892
United States, Pennsylvania
Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 726
Philadelphia, Pennsylvania, United States, 19102
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Judith L. Ross, M.D. Thomas Jefferson University
  More Information

No publications provided by Thomas Jefferson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00029159     History of Changes
Other Study ID Numbers: R01NS32531
Study First Received: January 8, 2002
Last Updated: June 4, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Turner syndrome
estrogen
androgen
growth hormone

Additional relevant MeSH terms:
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Turner Syndrome
Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Chromosome Disorders
Congenital Abnormalities
Disease
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Pathologic Processes
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities
Androgens
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014