Status:
COMPLETED
Effect of Biosynthetic Growth Hormone and/or Ethinyl Estradiol on Adult Height in Patients With Turner Syndrome
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Gonadal Dysgenesis
Turner's Syndrome
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Turners Syndrome is a genetic condition in females that is a result of abnormal chromosomes. Girls with Turner syndrome are very short as children and as adults. Although their growth hormone secretio...
Detailed Description
Adult women with Turner's syndrome are quite short. Several treatments have been used to increase growth rate in these patients. They include oxandrolone (1), growth hormone (2, 3), and low dose estro...
Eligibility Criteria
INCLUSION CRITERIA
All subjects will be outpatients.
Patients must be females with Turner's syndrome diagnosed by leukocyte karyotype
Chronologic age greater than or equal to 5 years.
Prepubertal Tanner I status. If breast development is Tanner II or III, demonstration of castrate status through measurement of serum FSH (greater than 12 MIU/ML).
All patients must be below the 10th percentile for chronologic age.
Patients must have at least 6 months accurate, growth measurements available for calculation of pre-study growth velocity. Pretreatment measurements must be obtained during a time when the patient is not receiving a potential growth-promoting agent.
Patients judged to be thyroxine deficient must have replacement which has resulted in normal thyroid function tests over the three-month period prior to enrollment (T4, T3, Thyroid Stimulating Hormone).
Patients and/or parents or legal guardians of patients must sign an informed consent statement. Assent should be obtained from all patients competent to understand the protocol. Local IRB requirements apply.
EXCLUSION CRITERIA
Patients who have received any form of human growth hormone within the past 3 months, or who have received a cumulative course of therapy totaling greater than one year.
Patients who have received treatment with estrogen or androgen in the past three months or who have received a cumulative course of therapy totaling greater than one year.
Patients who have any Y component in their chromosome analysis.
Patients with a chronologic age greater than 12 years.
Patients with a bone age greater than 12 years.
Patients who have clinically significant cardiac, pulmonary, gastrointestinal, hepatic or renal disease or who have had any malignancy.
Patients who have significant hematuria or proteinuria in pretherapy evaluation.
Patients who have diabetes mellitus.
Patients who have any active chronic infection (tuberculosis).
Patients who are taking amphetamines or any other drugs known to interfere with growth hormone secretion or actions.
Patients who are poor medical, psychological, or psychiatric risks for whom, in the opinion of the principal investigator, the investigational drug would be unwise.
Patients whose parents are substance abusers, nor those who come from homes in which appropriate emotional development may be limited.
Patients who cannot be seen on the schedule required by the protocol.
Key Trial Info
Start Date :
September 1 1987
Trial Type :
INTERVENTIONAL
End Date :
September 1 2003
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00001221
Start Date
September 1 1987
End Date
September 1 2003
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892