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

Last updated: August 25, 2016
Sponsor: Beijing Children's Hospital
Overall Status: Trial Status Unknown

Phase

4

Condition

Hormone Deficiencies

Hypogonadism

Treatment

N/A

Clinical Study ID

NCT02880280
BeijingChildrens-01
  • Ages 138-18
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

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 olfactorybulb 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 andthey have anosmia or dysplasia of olfactory bulb/olfactory sulcus/olfactory structs onMRI include in. Criteria C

  • As the phenotype of hypogonadotropic hypogonadism are variant, some of them may havepartial puberty. So, we enrolled them when they have testis volume >4ml or thetestosterone 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

Exclusion Criteria:

  • Any ascertain reason contributes to the non puberty development (Chromosome abnormal,trauma, surgeries) or any ascertain disease such as Prader-Willi syndrome orhypergonadotropic hypogonadism

  • Systemic diseases (such as chronic kidney failure, Mediterranean anemia, poorcontrolled 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

Total Participants: 40
Study Start date:
August 01, 2016
Estimated Completion Date:
December 31, 2018

Study 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.

Connect with a study center

  • Beijing Children's Hospital

    Beijing, Beijing 100045
    China

    Active - Recruiting

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