The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome
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|ClinicalTrials.gov Identifier: NCT00001343|
Recruitment Status : Completed
First Posted : November 4, 1999
Last Update Posted : July 2, 2017
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Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Patients with Turner syndrome are typically short, have abnormal physical features, and lack the physical changes normally associated with puberty. In addition, some patients with Turner syndrome have low bone density (osteoporosis) and differences in learning abilities.
This study will research the effects of steroid hormones on patients with Turner syndrome. It will look closely at how taking steroid hormones effects the patient's rate of growth as well as the patient's ability to learn. In addition the study will investigate how different hormones (androgen and estrogen) work when given together as a combination.
All patients asked to participate in this study will receive growth hormone injections. However, half of the patients will receive an additional sex steroid hormone (oxandrolone) in the form of a pill. The other half of the patients will receive a placebo or "sugar pill". This will allow the researchers to determine if the combination of the hormones produces different results than growth hormone alone.
The study will last approximately 2 years. After 2 years of research the patients may qualify for an additional 2 years of treatment. Patients may benefit directly from this research with increased growth and improved ability to learn.
|Condition or disease||Intervention/treatment||Phase|
|Dwarfism Turner's Syndrome||Drug: Humatrope Drug: Oxandrolone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Official Title:||The Relative Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate, GH Binding Protein, IGF-I, and Cognitive Function in Growth Hormone-Treated Girls With Turner Syndrome|
|Study Start Date :||December 11, 1992|
|Study Completion Date :||October 10, 2007|
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|Ages Eligible for Study:||10 Years to 14 Years (Child)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- INCLUSION CRITERIA:
Girls with Turner syndrome will qualify to participate in this study if they meet the following criteria:
Karyotype diagnosis compatible with Turner syndrome.
No treatment with estrogen, androgen or growth hormone exceeding twelve months, and no treatment with either of these agents in the preceding 3 months.
Chronological age of 10.0 to 14.9 years.
Bone age less than or equal to 12 years.
Prior treatment with estrogen, androgen, or growth hormone for more than twelve months.
Y component in peripheral karyotype.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001343
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107-6541|
|Other Study ID Numbers:||
|First Posted:||November 4, 1999 Key Record Dates|
|Last Update Posted:||July 2, 2017|
|Last Verified:||October 10, 2007|
Disorders of Sex Development
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Sex Chromosome Disorders of Sex Development
Male Urogenital Diseases
Heart Defects, Congenital
Sex Chromosome Disorders
Genetic Diseases, Inborn
Endocrine System Diseases
Bone Diseases, Developmental
Hormones, Hormone Substitutes, and Hormone Antagonists