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

August 25, 2016 updated by: Chunxiu Gong, Beijing Children's Hospital

Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin is Superior to Human Chorionic Gonadotropin in Therapeutic Efficacy in Adolescent Boys With Congenital Hypogonadotropic Hypogonadism

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
testicular volume
Time Frame: Change from Baseline testicular volume at 3 months after treatment
Change from Baseline testicular volume at 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Testosterone changes from 3 months onwards after treatment compared to pretreatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Children's Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (ESTIMATE)

August 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingChildrens-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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