To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placeb… (NCT06561594) | Clinical Trial Compass
Not Yet RecruitingPhase 3
To Evaluate Recombinant Human Follicle Stimulating Hormone-CTP Fusion Protein Injection or Placebo Combined With Chorionic Gonadotropin for Injection
China60 participantsStarted 2024-09-20
Plain-language summary
This study was conducted to evaluate recombinant human follicle stimulating hormone-CTP fusion protein injection or placebo combined with chorionic gonadotropin for injection
Who can participate
Age range14 Years – 17 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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., Klinefelte…
What they're measuring
1
Change from baseline in testicular volume (the sum of the volumes of the left and right testes measured on ultrasonography) after 64 weeks