Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001343
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
The Effects of Hormones in Growth Hormone-Treated Girls With Turner Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-10-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients rate of growth as well as the patients 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
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 patients rate of growth as well as the patients 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
Detailed Description:
Turner syndrome is associated with short stature multiple physical stigmata and absent pubertal development We propose to 1 examine the effects of sex steroids androgen on multiple variables growth rate GH binding protein IGF-I 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 on the above variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 93-CH-0054 | None | None | None |