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

Overview

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.

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

Primary outcome measures

• Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks [Time frame: 64 weeks after administration]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 17 centers

• Anhui Children's Hospital — Hefei
• Beijing Children's Hospital, Capital Medical University — Beijing
• Peking Union Hospital, Chinese Academy of Medical Sciences — Beijing
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
• Women and Children's Medical Center Affiliated to Guangzhou Medical University — Guangzhou
• Shenzhen Children's Hospital — Shenzhen
• Henan Children's Hospital Zhengzhou Children's Hospital — Zhengzhou
• … and 9 more centers

Identifiers

NCT: NCT06561594 · GenSci094-303

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗