Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2026-01-03 @ 9:20 AM
Study NCT ID:
NCT02427958
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2015-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
Sponsor:
Takeda
Organization:
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 3.75 mg subcutaneous injection every 4 weeks for 96 weeks. Participants with body weight \<20 kg will receive recommended dose of 1.88 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 3.75 mg subcutaneous injection every 4 weeks for 96 weeks. Participants with body weight \<20 kg will receive recommended dose of 1.88 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:
False
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?: