Clinical trial NCT06561594: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Idiopathic Hypogonadotropic Hypogonadism
Lead sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-20
Enrollment: 60
Sex: MALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: recombinant human follicle-stimulating hormone-CTP Fusion protein injection or placebo combined with chorionic gonadotropin for injection
Primary purpose: TREATMENT

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

Detailed description: 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 to initiate or restore puberty in idiopathic hypogonadotropin hypogonadism in adolescent males aged 14 to 18 years.

Eligibility criteria: 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 outcomes:
measure: Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks
timeFrame: 64 weeks after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Children's Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking Union Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: GuangZhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Women and Children's Medical Center Affiliated to Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Children's Hospital Zhengzhou Children's Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: Nanjing Children's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Children's Hospital
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital affiliated to China Medical University
state: Liaoning
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical College
state: Shangdong
city: Shanghai
country: China
facility: Shanghai Children's Hospital
state: Shanghai
city: ShangHai
country: China
facility: Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Affiliated Pediatric Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Women and Children's Central Hospital
state: Sichuan
Study officials:
References: