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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 20, 2024

Primary Completion Date

November 23, 2024

Study Completion Date

December 23, 2026

Conditions
Idiopathic Hypogonadotropic Hypogonadism
Interventions
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

Trial Locations (17)

100045

Beijing Children's Hospital, Capital Medical University, Beijing

100730

Peking Union Hospital, Chinese Academy of Medical Sciences, Beijing

110004

Shengjing Hospital affiliated to China Medical University, Shenyang

200062

Shanghai Children's Hospital, Shanghai

200125

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai

201102

Affiliated Pediatric Hospital of Fudan University, Shanghai

210093

Nanjing Children's Hospital, Nanjing

230022

Anhui Children's Hospital, Hefei

272100

Affiliated Hospital of Jining Medical College, Jining

330200

Jiangxi Children's Hospital, Nanchang

430030

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

450018

Henan Children's Hospital Zhengzhou Children's Hospital, Zhengzhou

510080

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

510120

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

510623

Women and Children's Medical Center Affiliated to Guangzhou Medical University, Guangzhou

518026

Shenzhen Children's Hospital, Shenzhen

610073

Chengdu Women and Children's Central Hospital, Chengdu

All Listed Sponsors
lead

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

NCT06561594 - To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection | Biotech Hunter | Biotech Hunter