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NOT YET RECRUITING
NCT06561594
PHASE3

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.

View on ClinicalTrials.gov

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

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

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