Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001190
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Study of Luteinizing Hormone-Releasing Hormone Analog LHRHa in Pubertal Patients With Extreme Short Stature
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:
A Double-Blind Randomized Placebo-Controlled Clinical Trial of Luteinizing Hormone-Releasing Hormone Analog LHRHa in Pubertal Patients With Extreme Short Stature
Status:
COMPLETED
Status Verified Date:
2001-10
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:
Children with extreme short stature height and their families often experience significant psychological stress related to concerns about adult height In addition short stature often results in life-long emotional social and physical obstacles to the affected person
Normal growth occurs in two phases The first phase known as childhood growth occurs below the age of 10 The second phase of growth teen-age or adolescent growth begins between the ages of 10 and 15 In addition puberty marks the time when the bones growth plates epiphysis begin to close initiating the completion of linear growth height
Some children suffer from a condition called precocious puberty meaning that puberty begins at a younger age than normal The development of medications known as synthetic LHRH analogs have provided a method to delay puberty and treat these patients
LHRHa deslorelin is a hormone created to act like naturally occurring LHRH It been used in patients diagnosed with precocious early onset puberty The drugs were able to regress patients clinical signs of puberty decrease the levels of adult sex hormones produced and slow the rate of bone aging
Normal growth occurs in two phases The first phase known as childhood growth occurs below the age of 10 The second phase of growth teen-age or adolescent growth begins between the ages of 10 and 15 In addition puberty marks the time when the bones growth plates epiphysis begin to close initiating the completion of linear growth height
Some children suffer from a condition called precocious puberty meaning that puberty begins at a younger age than normal The development of medications known as synthetic LHRH analogs have provided a method to delay puberty and treat these patients
LHRHa deslorelin is a hormone created to act like naturally occurring LHRH It been used in patients diagnosed with precocious early onset puberty The drugs were able to regress patients clinical signs of puberty decrease the levels of adult sex hormones produced and slow the rate of bone aging
Detailed Description:
Children with extreme short stature and their families frequently experience significant psychological stress related to concerns about adult height Additionally extreme short stature often presents life-long emotional social and physical obstacles to the affected individual The onset of puberty in such patients presents a critical management problem because puberty initiates the process of epiphyseal closure that terminates linear growth Until recently there was no way to delay the onset of puberty in such patients The development of synthetic LHRH analogs however has provided such a method Administration of such analogs to children with precocious puberty caused a regression of their clinical signs of puberty a decrease in their gonadotropins and sex steroids and a slowing of the rate of bone age advancement
We propose to treat pubertal children with extreme short stature with a long-acting analog of luteinizing hormone-releasing hormone D-Trp6-Pro9-NEt-LHRHa The goal of LHRHa treatment in these children is to halt the normal progression into puberty and thereby delay epiphyseal fusion We postulate that delay of puberty will prolong pre-pubertal growth prior to the pubertal spurt and subsequent epiphyseal fusion and thus will enhance ultimate height This study will test this hypothesis through a double-blind randomized comparison of the effect of LHRHa and placebo on final adult height Patients will be treated with LHRHa or placebo for 4 years and will then be followed until they have completed puberty and have stopped growing
We propose to treat pubertal children with extreme short stature with a long-acting analog of luteinizing hormone-releasing hormone D-Trp6-Pro9-NEt-LHRHa The goal of LHRHa treatment in these children is to halt the normal progression into puberty and thereby delay epiphyseal fusion We postulate that delay of puberty will prolong pre-pubertal growth prior to the pubertal spurt and subsequent epiphyseal fusion and thus will enhance ultimate height This study will test this hypothesis through a double-blind randomized comparison of the effect of LHRHa and placebo on final adult height Patients will be treated with LHRHa or placebo for 4 years and will then be followed until they have completed puberty and have stopped growing
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 |
|---|---|---|---|
| 83-CH-0199 | None | None | None |