Kallmann SyndromePhase 4NCT02880280
Human Menopausal Gonadotropin Combining With Human Chorionic Gonadotropin Treat Congenital Hypogonadotropic Hypogonadism
A Phase 4 study testing Human Menopausal Gonadotropin and Human Chorionic Gonadotropin in people with Kallmann Syndrome and Hypogonadotropic Hypogonadism, run by Beijing Children's Hospital at 1 site in China.
Trial summary
Observe the therapeutic efficacy of human menopausal gonadotropin combining with human chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism. Read more about this study
- Who is it for?
- Ages 138 months to 18 years, men only
- Conditions the study is for
- Kallmann Syndrome, Hypogonadotropic Hypogonadism
- What is being tested?
- Human Menopausal Gonadotropin and Human Chorionic Gonadotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 138 months to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Children's Hospital
Beijing, Beijing Municipality, 100045
Ying Liu, master, +8615001091953, judyjudy5479@aliyun.com
Chunxiu Gong, doctor, +8613370115001, chunxiugong@sina.com
About this study
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
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.
- Conditions
- Kallmann Syndrome, Hypogonadotropic Hypogonadism
- Being tested
- Human Menopausal Gonadotropin, Human Chorionic Gonadotropin
- Medical subject headings
- Kallmann Syndrome, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Menopausal GonadotropinDrug
Also called Human Menopausal Gonadotropin(hMG)
Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers
Human Chorionic GonadotropinDrug
Also called Human Chorionic Gonadotropin(hCG)
Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers
| Study group | Role | What they receive |
|---|---|---|
| Human Menopausal Gonadotropin | Experimental | Human menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH) Receives: Drug: Human Menopausal Gonadotropin; Drug: Human Chorionic Gonadotropin |
| Human Chorionic Gonadotropin | Experimental | Human chorionic gonadotropin (hCG) is a hormone produced by the embryo after implantation Receives: Drug: Human Chorionic Gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
testicular volume
Measured: 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)
Measured: Testosterone changes from 3 months onwards after treatment compared to pretreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kallmann SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunxiu Gong, Beijing Children's Hospital
- Investigators
- Chunxiu Gong, doctor, Study director, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880280
- Sponsor's protocol ID
- BeijingChildrens-01
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02880280
- Acronym / sponsor ID
- BeijingChildrens-01
- Conditions
- Kallmann Syndrome, Hypogonadotropic Hypogonadism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observe the therapeutic efficacy of human menopausal gonadotropin combining with human chorionic gonadotropin in adolescent boys with congenital hypogonadotropic hypogonadism.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Menopausal Gonadotropin | Experimental | Drug: Human Menopausal Gonadotropin, Drug: Human Chorionic GonadotropinHuman menopausal gonadotropin contains follicle-stimulating hormone (FSH) and luteinizing hormone (LH) |
| Human Chorionic Gonadotropin | Experimental | Drug: Human Chorionic GonadotropinHuman chorionic gonadotropin (hCG) is a hormone produced by the embryo after implantation |
Who may qualify
- Ages
- 138 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Menopausal GonadotropinAlso: Human Menopausal Gonadotropin(hMG)Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers | Drug | Human Menopausal Gonadotropin |
| Human Chorionic GonadotropinAlso: Human Chorionic Gonadotropin(hCG)Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers | Drug | Human Chorionic Gonadotropin, Human Menopausal Gonadotropin |
Primary outcome
testicular volume
Time frame: Change from Baseline testicular volume at 3 months after treatment
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Derived from this study: PubMed 33813517Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunxiu Gong, doctor study director
Beijing Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human Menopausal Gonadotropin and Human Chorionic Gonadotropin in people with Kallmann Syndrome and Hypogonadotropic Hypogonadism, run by Beijing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Liu, master (+8615001091953, judyjudy5479@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
testicular volume (time frame: Change from Baseline testicular volume at 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.