Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02427958
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2015-04-23
Brief Title:
A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
An Open Label Multicenter Study to Assess the Safety and Efficacy 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 assess long-term safety and efficacy of leuprorelin in the treatment of Central Precocious Puberty CPP
Detailed Description:
The drug in this study is called leuprorelin It is administered as a 1 month subcutaneous depot injection Leuprorelin is used to treat children who have CPP This study will look at whether leuprorelin can stop early puberty in pre-pubertal children
The study will enroll approximately 300 participants Participants with body weight 20 kg will receive the recommended dose of leuprorelin 375 mg subcutaneous injection every 4 weeks for 96 weeks Participants with body weight 20 kg will receive recommended dose of 188 mg subcutaneous injection every 4 weeks for 96 weeks
This trial will be conducted in China The overall time to participate in this study is 104 weeks Participants will make 11 visits to the clinic and will be followed-up by the physician on a long-term basis until stable puberty is reached
The study will enroll approximately 300 participants Participants with body weight 20 kg will receive the recommended dose of leuprorelin 375 mg subcutaneous injection every 4 weeks for 96 weeks Participants with body weight 20 kg will receive recommended dose of 188 mg subcutaneous injection every 4 weeks for 96 weeks
This trial will be conducted in China The overall time to participate in this study is 104 weeks Participants will make 11 visits to the clinic and will be followed-up by the physician on a long-term basis until stable puberty is reached
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20140148 | REGISTRY | SFDA CTR | None |
| U1111-1183-0353 | REGISTRY | None | None |