Status:
NOT_YET_RECRUITING
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
Idiopathic Hypogonadotropic Hypogonadism
Eligibility:
MALE
14-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 23 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06561594
Start Date
September 20 2024
End Date
December 23 2026
Last Update
August 20 2024
Active Locations (17)
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1
Anhui Children's Hospital
Hefei, Anhui, China, 230022
2
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
3
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730
4
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080