Ignite Creation Date:
2024-05-06 @ 9:30 AM
Last Modification Date:
2024-10-26 @ 12:15 PM
Study NCT ID:
NCT02993926
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2016-12-13
Brief Title:
A Study to Assess the Safety and Efficacy of Enantone Leuprorelin in Central Precocious Puberty CPP Among Chinese Participants
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
An Observational Retrospective Study to Evaluate the Long Term Safety and Effectiveness of Leuprorelin in the Treatment of Central Precocious Puberty
Status:
COMPLETED
Status Verified Date:
2022-03
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 evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants
Detailed Description:
The drug being evaluated in this study is called Enantone leuprorelin Enantone is used to treat children who have CPP This study will look at long term safety and efficacy of leuprorelin in the treatment of Chinese participants with CPP
The study will enroll approximately 300 participants
All participants who have received leuprorelin 30 mcgkg to 90 mcgkg or 90 mcgkg to 180 mcgkg per body weight injection subcutaneously every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed
This multi-center trial will be conducted in China Data will be collected over period of 20 months
The study will enroll approximately 300 participants
All participants who have received leuprorelin 30 mcgkg to 90 mcgkg or 90 mcgkg to 180 mcgkg per body weight injection subcutaneously every 4 weeks up to at least 9 continuous months during the index period from September 1st 1998 to September 30th 2018 will be observed
This multi-center trial will be conducted in China Data will be collected over period of 20 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None