Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin Treat Congenital Hypogonadotropic Hypogonadism

Phase 4

• Conditions: Kallmann Syndrome; Hypogonadotropic Hypogonadism
• Interventions: Drug: Human Menopausal Gonadotropin; Drug: Human Chorionic Gonadotropin

• Registration Number: NCT02880280
• Lead Sponsor: Beijing Children's Hospital

Brief Summary

Observe the therapeutic efficacy of human menopausal gonadotropin combining with human chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.

Detailed Description

Observe safety and efficacy of human menopausal gonadotropin and human chorionic gonadotropin treating congenital hypogonadotropic hypogonadism in teenagers; which as clinic recommendation, may provide clinical basis for establishing standard treatment guideline in the future. Establish technological process and follow-up precept for human menopausal gonadotropin and human chorionic gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers. And find safety and effective dose for teenagers.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-25
• Last Update Submitted: 2016-08-25
• Study First Posted: 2016-08-26
• Last Update Posted: 2016-08-26
• Primary Completion: 2017-08
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

• Any ascertain reason contributes to the non puberty development (Chromosome abnormal, trauma, surgeries) or any ascertain disease such as Prader-Willi syndrome or hypergonadotropic hypogonadism
• Systemic diseases (such as chronic kidney failure, Mediterranean anemia, poor controlled diabetes)
• Protein-energy malnutrition
• Eating disorder (such as anorexia nervosa, binge eating)
• Any brain diseases history: tumors in brain or pituitary or after their surgeries

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Menopausal Gonadotropin	Human Menopausal Gonadotropin	Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH)
Human Menopausal Gonadotropin	Human Chorionic Gonadotropin	Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH)
Human Chorionic Gonadotropin	Human Chorionic Gonadotropin	Human chorionic gonadotropin (hCG) is a hormone produced by the embryo after implantation

Primary Outcome Measures

Name	Time	Method
testicular volume	Change from Baseline testicular volume at 3 months after treatment

Secondary Outcome Measures

Name	Time	Method
The levels of testosterone serum (It were measured with chemiluminescent immunoassay Elecsys)	Testosterone changes from 3 months onwards after treatment compared to pretreatment

Trial Locations

Locations (1)

Beijing Children's Hospital; 🇨🇳 Beijing, Beijing, China