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Trial record 4 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

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ClinicalTrials.gov Identifier: NCT02880280
Recruitment Status : Unknown
Verified August 2016 by Chunxiu Gong, Beijing Children's Hospital.
Recruitment status was:  Recruiting
First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Chunxiu Gong, 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.

Condition or disease Intervention/treatment Phase
Kallmann Syndrome Hypogonadotropic Hypogonadism 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2018


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 Name: Human Menopausal Gonadotropin(hMG)

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




Primary Outcome Measures :
  1. testicular volume [ Time Frame: 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) [ Time Frame: Testosterone changes from 3 months onwards after treatment compared to pretreatment ]


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Ages Eligible for Study:   138 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880280


Contacts
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Contact: Ying Liu, master +8615001091953 judyjudy5479@aliyun.com
Contact: Chunxiu Gong, doctor +8613370115001 chunxiugong@sina.com

Locations
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China, Beijing
Beijing Children's Hospital Recruiting
Beijing, Beijing, China, 100045
Contact: Ying Liu, master    +8615001091953    judyjudy5479@aliyun.com   
Contact: Chunxiu Gong, doctor    +8613370115001    chunxiugong@sina.com   
Sponsors and Collaborators
Beijing Children's Hospital
Investigators
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Study Director: Chunxiu Gong, doctor Beijing Children's Hospital

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Responsible Party: Chunxiu Gong, Professor, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT02880280     History of Changes
Other Study ID Numbers: BeijingChildrens-01
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Kallmann Syndrome
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Disorder of Sex Development, 46,XY
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Menotropins
Reproductive Control Agents
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents