Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT06561594
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-20
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Follicle-stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection in Idiopathic Hypogonadotropin Hypogonadism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection
Detailed Description:
A multicenter, randomized, double-blind, Phase III clinical study to evaluate the efficacy and safety of recombinant human follicle-stimulating hormone-CTP Fusion protein injection or placebo combined with chorionic gonadotropin for injection to initiate or restore puberty in idiopathic hypogonadotropin hypogonadism in adolescent males aged 14 to 18 years.
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?: