Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05341115
Status:
RECRUITING
Last Update Posted:
2024-02-12
First Post:
2022-04-18
Brief Title:
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
An Open Label Multicenter Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty CPP
Status:
RECRUITING
Status Verified Date:
2024-02
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 main aim is to see how leuprolide works to treat central precocious puberty in children Participants will receive an injection of leuprorelin acetate depot 1125 mg every 12 weeks during 6 months and will visit their study clinic 6 times to complete some assessments
Detailed Description:
The drug being tested in this study is called leuprorelin acetate depot 3M Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty This study will look at the efficacy and safety of leuprorelin acetate depot 3M in the treatment of CPP
The study will enroll approximately 80 participants with CPP Participants with a bodyweight of 20 kg will receive the recommended dose of leuprorelin acetate depot 3M in a 24 weeks Treatment Period followed by a 12 weeks Post-treatment follow-up period Participants will be assigned to the following drug administration
Leuprorelin Acetate Depot 3M 1125 mg
Participants will receive leuprorelin acetate depot 3M 1125 mg as subcutaneous SC injection on Weeks 0 12 and 24 The gonadotropin-releasing hormone agonist GnRHa stimulation basal luteinizing hormone LH and follicle-stimulating hormone FSH levels will be tested pre-dose of every SC injection of the study drug or at premature termination
This multi-center trial will be conducted in China The overall time to participate in this study is 38 weeks Participants will make a follow-up visit to the site at approximately 12 weeks after the last dose of study treatment
The study will enroll approximately 80 participants with CPP Participants with a bodyweight of 20 kg will receive the recommended dose of leuprorelin acetate depot 3M in a 24 weeks Treatment Period followed by a 12 weeks Post-treatment follow-up period Participants will be assigned to the following drug administration
Leuprorelin Acetate Depot 3M 1125 mg
Participants will receive leuprorelin acetate depot 3M 1125 mg as subcutaneous SC injection on Weeks 0 12 and 24 The gonadotropin-releasing hormone agonist GnRHa stimulation basal luteinizing hormone LH and follicle-stimulating hormone FSH levels will be tested pre-dose of every SC injection of the study drug or at premature termination
This multi-center trial will be conducted in China The overall time to participate in this study is 38 weeks Participants will make a follow-up visit to the site at approximately 12 weeks after the last dose of study treatment
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 |
|---|---|---|---|
| 2022-002471-11 | EUDRACT_NUMBER | None | None |