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Status unknownNCT02880280Updated Aug 26, 2016

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

A Phase 4 interventional study of Human Menopausal Gonadotropin and Human Chorionic Gonadotropin in Kallmann Syndrome and Hypogonadotropic Hypogonadism, sponsored by Beijing Children's Hospital. Status unknown at 1 site in China. Open to male participants aged 138 Months to 18 Years. Per ClinicalTrials.gov, last updated 2016-08-26.

Sponsored by Beijing Children's Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
138 Months to 18 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Kallmann Syndrome
  • Hypogonadotropic Hypogonadism
03

In context

Kallmann Syndrome

21 studies on the registry are indexed under Kallmann Syndrome; 5 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 13 interventional studies indexed under Kallmann Syndrome.

Browse Kallmann Syndrome studies →

Lead sponsor

Beijing Children's Hospital is the lead sponsor of 51 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
138 Months to 18 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Human Menopausal Gonadotropin

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

    Drug: Human Menopausal Gonadotropin · Drug: Human Chorionic Gonadotropin

  • Experimental
    Human Chorionic Gonadotropin

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

    Drug: Human Chorionic Gonadotropin

Interventions

  • DrugHuman Menopausal Gonadotropin

    Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

    Also known as: Human Menopausal Gonadotropin(hMG)

  • DrugHuman Chorionic Gonadotropin

    Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

    Also known as: Human Chorionic Gonadotropin(hCG)

06

What researchers measure

Primary outcomes

  1. testicular volume

    Time frame: Change from Baseline testicular volume at 3 months after treatment

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Liu Y, Ren XY, Peng YG, Chen SK, Cheng XR, Qin M, Wang XL, Song YN, Fan LJ, Gong CX. Efficacy and safety of human chorionic gonadotropin combined with human menopausal gonadotropin and a gonadotropin-releasing hormone pump for male adolescents with congenital hypogonadotropic hypogonadism. Chin Med J (Engl). 2021 Mar 31;134(10):1152-1159. doi: 10.1097/CM9.0000000000001419. PubMed 33813517 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02880280
Lead sponsor
Beijing Children's Hospital
Responsible party
Chunxiu Gong (Professor, Beijing Children's Hospital) — Principal investigator
First posted
Aug 26, 2016
Start date
Aug 2016
Primary completion
Aug 2017 (estimated)
Completion
Dec 2018 (estimated)
Last update
Aug 26, 2016

Study contacts

Ying Liu, master
Contact
judyjudy5479@aliyun.com
+8615001091953
Chunxiu Gong, doctor
Contact
chunxiugong@sina.com
+8613370115001
Chunxiu Gong, doctor
study director · Beijing Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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