To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
NCT ID: NCT06561594
Last Updated: 2024-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2024-09-20
2026-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group
30subjects：GenSci094 was administered for 12 weeks，150ug/0.5ml（weight\>60kg）or 100ug/0.5ml（weight≤60kg）；GenSci094 with chorionic gonadotropin for injection was administered for 52 weeks，150ug/0.5ml（weight\>60kg）or 100ug/0.5ml（weight≤60kg）with chorionic gonadotropin for injection.
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
Placebo group
30subjects：GenSci094 Placebo was administered for 12 weeks，150ug/0.5ml（weight≥60kg）or 100ug/0.5ml（weight\<60kg）；GenSci094 Placebo with chorionic gonadotropin for injection was administered for 52 weeks，150ug/0.5ml（weight≥60kg）or 100ug/0.5ml（weight\<60kg）with chorionic gonadotropin for injection.
recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo
0.5ml, H. Administer the drug once every 14 days for 64 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
14 Years
17 Years
MALE
No
Sponsors
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Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GenSci094-303
Identifier Type: -
Identifier Source: org_study_id
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