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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT02880280 (opens ClinicalTrials.gov in a new tab)Other idBeijingChildrens-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
40 participants (estimated)
Sponsor
Beijing Children's Hospital · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

China

Start
Aug 2016
Primary completion
Aug 2017 (estimated)
Completion
Dec 2018 (estimated)
First posted
26 Aug 2016 (estimated)
Last update posted
26 Aug 2016 (estimated)
Conditions
Kallmann Syndrome · Hypogonadotropic Hypogonadism

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2016201720182019
  1. Ph 4

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

    NCT02880280

    Aug 2016 to est. Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Human Menopausal GonadotropinDrug
  • Human Chorionic GonadotropinDrug

Arms2

  • Experimental

    Human Menopausal Gonadotropin

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

  • Experimental

    Human Chorionic Gonadotropin

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. testicular volume

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

Secondary outcomes(1)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2021

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.

Liu et al. 2021Chinese medical journalcited by 9

PMID 33813517PMC8143779DOI 10.1097/cm9.0000000000001419PUB-33813517

Free to read · publisher termsCC BY-NC-ND
Read at source

Eligibility

Who could join, as posted.

Sex
Male
Age
from 138 Months up to 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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