Ignite Creation Date:
2024-05-05 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00660010
Status:
COMPLETED
Last Update Posted:
2011-04-12
First Post:
2008-04-15
Brief Title:
Study of Lupron Depot In The Treatment of Central Precocious Puberty
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
Study of Lupron Depot In The Treatment of Central Precocious Puberty
Status:
COMPLETED
Status Verified Date:
2011-04
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 purpose of this study is to determine if Lupron leuprolide acetate is safe and effective in treating children with Central Precocious Puberty CPP and to assess long term effects of leuprolide acetate treatment after therapy is discontinued
Detailed Description:
This study includes a Prestudy Period a treatment period where subjects will receive treatment every 4 weeks until the initiation of puberty age 12 for males and age 11 for females a follow-up period where subjects will be observed every 6 months until physical and laboratory observations are at pubertal levels then every 12 months for 5 years lastly a final follow-up questionnaire is given to all subjects when they are at least 18 years old
At the treatment visits efficacy assessments are Tanner staging suppression of breast development in females and genital development in males gonadotropins LH and FSH sex steroids estradiol in females and testosterone in males ratio of bone age to chronological age adult height compared to a standard population and predicted mature height and age and time to regular menses in females This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies
At the treatment visits efficacy assessments are Tanner staging suppression of breast development in females and genital development in males gonadotropins LH and FSH sex steroids estradiol in females and testosterone in males ratio of bone age to chronological age adult height compared to a standard population and predicted mature height and age and time to regular menses in females This protocol will also capture data from the final questionnaire about female reproductive status at adulthood including the presence of regular menses and number of pregnancies
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