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

Sponsor
Beijing Children's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02880280
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
28
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Human Menopausal Gonadotropin
  • Drug: Human Chorionic Gonadotropin
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin is Superior to Human Chorionic Gonadotropin in Therapeutic Efficacy in Adolescent Boys With Congenital Hypogonadotropic Hypogonadism
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Human Menopausal Gonadotropin

Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH)

Drug: Human Menopausal Gonadotropin
Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers
Other Names:
  • Human Menopausal Gonadotropin(hMG)

    • Drug: Human Chorionic Gonadotropin
    Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers
    Other Names:
  • Human Chorionic Gonadotropin(hCG)

    		•
    Experimental: Human Chorionic Gonadotropin

    Human chorionic gonadotropin (hCG) is a hormone produced by the embryo after implantation

    Drug: Human Chorionic Gonadotropin
    Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers
    Other Names:
  • Human Chorionic Gonadotropin(hCG)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. testicular volume [Change from Baseline testicular volume at 3 months after treatment]

    Secondary Outcome Measures

    1. The levels of testosterone serum (It were measured with chemiluminescent immunoassay Elecsys) [Testosterone changes from 3 months onwards after treatment compared to pretreatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    138 Months to 18 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    Criteria A

    • Boy >14yr without any sign of puberty, testis <4ml

    • BA ≥12yr

    • Sex hormone (LH,FSH, T) are pre-pubertal level

    • No other hormones problems (other pituitary glands axis are normal except gonad axis)

    • No space occupying lesion, No tumor on MRI of pituitary and hypothalamus area

    • Kallmann's syndrome(KS) patients may companies with dysosmia or dysplasia of olfactory bulb or olfactory tract on MRI

    • Karyotype is 46，XY

    • Exclude chronic diseases, malnutrition

    Criteria B

    • For the boy <14yr. who companies with micropenis or cryptorchid or hypospadias and they have anosmia or dysplasia of olfactory bulb/olfactory sulcus/olfactory structs on MRI include in.

    Criteria C

    • As the phenotype of hypogonadotropic hypogonadism are variant, some of them may have partial puberty. So, we enrolled them when they have testis volume >4ml or the testosterone level >200ng/L，companies anosmia or dysplasia of olfactory bulb /olfactory sulcus/ olfactory structs on MRI, and the puberty arrested in half a year. These patients can be diagnosed as Kallmann Syndrome.
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Children's Hospital Beijing Beijing China 100045

    Sponsors and Collaborators

    • Beijing Children's Hospital

    Investigators

    • Study Director: Chunxiu Gong, doctor, Beijing Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chunxiu Gong, Professor, Beijing Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT02880280
    Other Study ID Numbers:
    • BeijingChildrens-01
    First Posted:
    Aug 26, 2016
    Last Update Posted:
    Aug 26, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Kallmann Syndrome
    Hypogonadism
    Chorionic Gonadotropin
    Menotropins

    Study Results

    No Results Posted as of Aug 26, 2016