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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 17
- 主要终点
- Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks
研究概览
简要总结
This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: recombinant human follicle-stimulating hormone-CTP Fusion protein injection (Drug)
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.
干预措施: recombinant human follicle-stimulating hormone-CTP Fusion protein injection Placebo (Drug)
结局指标
主要结局
Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks
时间窗: 64 weeks after administration
次要结局
未报告次要终点