Back to resultsThe Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome
Primary Purpose
Turner Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
estrogen
androgen
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Turner Syndrome focused on measuring Turner syndrome, estrogen, androgen, growth hormone
Eligibility 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.
Sites / Locations
- National Institutes of Health
- Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 726
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Cognitive function in girls with Turner Syndrome
Secondary Outcome Measures
Full Information
NCT ID
NCT00029159
First Posted
January 8, 2002
Last Updated
June 4, 2012
Sponsor
Thomas Jefferson University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00029159
Brief Title
The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 1992 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner Syndrome
Keywords
Turner syndrome, estrogen, androgen, growth hormone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
estrogen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
androgen
Intervention Description
Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
an inactive substance
Primary Outcome Measure Information:
Title
Cognitive function in girls with Turner Syndrome
Time Frame
4 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith L. Ross, M.D.
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 726
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20733274
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome
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