NCT06561594

To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Hypogonadotropic Hypogonadism

Interventions

Type	Name	Description
DRUG	recombinant human follicle-stimulating hormone-CTP Fusion protein injection	IF Weight \> 60kg，150ug, H. Administer the drug once every 14 days for 64 weeks；IF Weight \>≤60kg，100ug, H. Administer the drug once every 14 days for 64 weeks
DRUG	recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo	0.5ml, H. Administer the drug once every 14 days for 64 weeks

Timeline

• Start date: 2024-09-20
• Primary completion: 2024-11-23
• Completion: 2026-12-23
• First posted: 2024-08-20
• Last updated: 2024-08-20

Locations

17 sites across 1 country: China