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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.
Summary
This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection
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
Key Details
Gender
MALE
Age Range
14 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-09-20
Completion Date
2026-12-23
Last Updated
2024-08-20
Healthy Volunteers
No
Conditions
Interventions
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
recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo
0.5ml, H. Administer the drug once every 14 days for 64 weeks
Locations (17)
Anhui Children's Hospital
Hefei, Anhui, China
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Women and Children's Medical Center Affiliated to Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Nanjing Children's Hospital
Nanjing, Jiangsu, China
Jiangxi Children's Hospital
Nanchang, Jiangxi, China
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China
Affiliated Hospital of Jining Medical College
Jining, Shangdong, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Affiliated Pediatric Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, China