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 range
14 Years – 17 Years
Sex
MALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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