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

Hypogonadotropic Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02880280
• Other study ID #: BeijingChildrens-01
• Status: Recruiting
• Phase: Phase 4
• First received: August 11, 2016
• Last updated: August 25, 2016
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Beijing Children's Hospital
• Contact: Ying Liu, master
• Phone: +8615001091953
• Email: judyjudy5479[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 138 Months to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadotropic Hypogonadism
• Kallmann Syndrome

Intervention

Drug:
• Human Menopausal Gonadotropin
Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers
• Human Chorionic Gonadotropin
Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	testicular volume		Change from Baseline testicular volume at 3 months after treatment	No
Secondary	The levels of testosterone serum (It were measured with chemiluminescent immunoassay Elecsys)		Testosterone changes from 3 months onwards after treatment compared to pretreatment	No