Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140998
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2005-08-30
Brief Title:
Estrogen Treatment Oral vs Patches in Turner Syndrome
Sponsor:
Nemours Childrens Clinic
Organization:
Nemours Childrens Clinic
Study Overview
Official Title:
Estrogen Replacement in Hypogonadal Girls Treated With GH Differential Effects of Mode of Estrogen Delivery
Status:
COMPLETED
Status Verified Date:
2017-08
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:
The study attempts to evaluate if the way of administering estrogen the principal female hormone via patches or orally affects the way estrogen works in girls with Turner Syndrome These are girls who are very short and whose ovaries do not work We will examine changes bone protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally These studies are conducted while the girls are taking GH therapy
Detailed Description:
Girls with Turner Syndrome between the ages of 10-16 years were chosen as the study population The study requires 3 overnight admissions to an in-patient Clinical Research CenterCRC A baseline study is performed using stable isotope tracers of leucine glycerol and glucose and serial blood sampling to measure protein and fat metabolism Indirect calorimetry is used to measure substrate oxidation rates and total energy expenditure DEXA scan is used to measure bone mineral density and body composition Once the baseline study is complete subjects are randomly assigned to receive either estrogen orally or through a patch placed onto the skin in increasing doses changed every 2 weeks After 6 weeks of estrogen treatment a second metabolic study identical to the first is performed followed by a wash out period of 4 weeks Subsequently the subjects are switched to the alternate form of estrogen At the end of 6 weeks a third and final metabolic study is repeated All subjects continue to be on growth hormone throughout the study procedures
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