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Clinical Trials in China / NCT06561594
Starting soon Phase 3

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

NCT06561594 · tracked via the Priya Life Science China tracker
Sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Phase
Phase 3
Started
2024-09-20
Last updated
2024-08-20

Condition(s) studied

Idiopathic Hypogonadotropic Hypogonadism

Investigational drug(s) / intervention(s)

recombinant human follicle-stimulating hormone-CTP Fusion protein injectionrecombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo

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

Study summary

This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection

Eligibility

Sex
MALE
Min age
14 Years
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: * The guardian and subject are aware of the study procedures, available alternative treatments, and the risks of participating in the study, and voluntarily sign a written ICF to voluntarily participate in the study. * Age 14-18 years old (excluding 18 years old) at the time of signing the ICF, with bone age greater than 12 years old. * Height ≥145cm and body mass index (BMI) \< 30kg/m2 when signing ICF. * Diagnosis of idiopathic or congenital hypogonadotropic hypogonadism. * The presence of bilateral pre-gonadal onset testis during the screening period: testicular volume \<4 mL on each side (determined by ultrasound and evaluated by 2 qualified ultrasound specialists authorized by the researchers of the research center). * The circulating gonadotropin (Gn) level was low (FSH≤1 IU/L and LH≤1 IU/L) during the screening period, and the peak LH value of GnRH excitation test was ≤4 IU/L. * Serum testosterone T ≤ 1 ng/mL during the screening period. * The normal range of other pituitary hormones during the screening period (judged by the researcher). * Lesions detected by MRI on the head within 3 months before or during screening were normal or determined by the investigator to have no impact on the study. * Consent to the use of reliable contraception (e.g. abstinence, condoms, etc.) by yourself and your sexual partner during the study period and for 3 months after the study drug treatment. Exclusion Criteria: There is primary hypogonadism (e.g., Klinefelter syndrome). * Hypogonadotropic hypogonadism caused by tumor, surgery, trauma, infection, or immune factors in the hypothalamic sella or pituitary gland. * History of unilateral or bilateral cryptorchidism and the presence of clinically significant testicular lesions (orchitis, testicular tumor, testicular torsion, severe varicocele (grade III), testicular atrophy, obstructive azoospermia, etc.). * Researchers identified uncontrolled endocrine diseases, including thyroid, adrenal diseases, diabetes, etc. * History of malignant tumors within 5 years prior to the screening period. * Patients who have received GnRH, gonadotropin or oral androgen (testosterone, etc.) therapy within 1 month before signing ICF, or who have received testosterone undecanoate intramuscular injection therapy within 1 year before signing ICF. * History of drug or substance abuse within 1 year prior to signing the ICF, drugs known to impair testicular function or affect the production of sex hormones, or alcohol abuse. * Abnormal liver and kidney function during screening, i.e. liver function: alanine aminotransferase and/or aspartate aminotransferase higher than 2 times the upper limit of normal (\>2×Upper limit of normal); Renal function: Creatinine and/or urea/urea nitrogen are 2 times higher than the upper limit of normal (\>2×Upper limit of normal). * During the screening period, patients with systemic diseases (such as metabolic abnormalities, circulatory, digestive, nervous system, etc.) judged by the researchers are not suitable for participation in this study. * Current thromboembolic disease or known prior history. * Hepatitis B surface antigen, hepatitis C antibody, HIV antibody and treponema pallidum antibody positive.● * People who are allergic to the active ingredients or excipients of FSH and hCG drugs or have a history of related allergies, or have a clear contraindication of drug use. * Participants who participated in other interventional clinical trials and used experimental drugs within 3 months prior to screening. * Patients with a history of depression or mental disorders. * Due to risk considerations, the researchers did not consider it appropriate to participate in other situations in this study.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Anhui Children's Hospital Hefei Anhui
Beijing Children's Hospital, Capital Medical University Beijing Beijing Municipality
Peking Union Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality
The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
Women and Children's Medical Center Affiliated to Guangzhou Medical University Guangzhou Guangdong
Shenzhen Children's Hospital Shenzhen Guangdong
Henan Children's Hospital Zhengzhou Children's Hospital Zhengzhou Henan
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Nanjing Children's Hospital Nanjing Jiangsu
Jiangxi Children's Hospital Nanchang Jiangxi
Shengjing Hospital affiliated to China Medical University Shenyang Liaoning
Affiliated Hospital of Jining Medical College Jining Shangdong
Shanghai Children's Hospital Shanghai Shanghai Municipality
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Affiliated Pediatric Hospital of Fudan University Shanghai Shanghai Municipality
Chengdu Women and Children's Central Hospital Chengdu Sichuan

More Changchun GeneScience Pharmaceutical Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06561594 on ClinicalTrials.gov ↗ ← All trials in China