UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047088 |
|---|---|
| Receipt number | R000053711 |
| Scientific Title | A multicenter study on infantile gonadotropin treatment for male hypogonadotropic hypogonadism (MHH) |
| Date of disclosure of the study information | 2022/03/05 |
| Last modified on | 2022/03/04 20:46:01 |
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Basic information
Public title
A study on infantile gonadotropin treatment for male hypogonadotropic hypogonadism
Acronym
Infantile gonadotropin treatment study (IGTS)
Scientific Title
A multicenter study on infantile gonadotropin treatment for male hypogonadotropic hypogonadism (MHH)
Scientific Title:Acronym
Infantile Gn treatment study for MHH
Region
| Japan |
Condition
Condition
Male hypogonadotropic hypogonadism
Classification by specialty
| Endocrinology and Metabolism | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of infantile gonadotropin treatment for male hypogonadotropic hypogonadism
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in penile length at the end of observation period, compared with pretreatment period
Key secondary outcomes
Efficacy
Change in testis size at the end of observation period, compared with pretreatment period
Change in testicular position at the end of observation period, compared with pretreatment period
Changes in serum anti-Mullerian hormone, testosterone, and FSH before, during, and after treatment
Safety
Changes in bone age before and after treatment
Presence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Human chorionic gonadotropin (hCG) preparation (Brand name: HCG for intramuscular injection) 500 IU once a week, intramuscular injection into the thigh
2. Recombinant human FSH (rFSH)
Subcutaneous injection of 25 IU 3 times a week
Continue for 12 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 30 | weeks-old | > |
Gender
Male
Key inclusion criteria
1. Prospective intervention trial group
1) Having one of the following three symptoms;
Small penis (extended penis length less than 25 mm)
Small testis (testis volume less than 1 mL)
Undescended testes examined at least once
2) Insufficiency of gonadotropin secretion confirmed by one of the following methods
A) LH value less than 0.5 (IU/L) at less than 210 days after birth
B) LH peak value less than 2 mIU/ml and LH/FSH ratio of less than 1.0 in LHRH test conducted less than 210 days after birth.
C)Identified hypoplasia of the olfactory bulb and olfactory sulcus
on MRI
2. Historical control group
Patients seen at the facility between April 2000 and March 2017 with a follow-up more than 3 years
The above 1) and 2) have been confirmed at the time of first medical examination or before treatment with testosterone etc.
Key exclusion criteria
1. Prospective intervention trial group
1) Patients who have been treated with gonadotropin preparations or any of the following prohibited drugs
2) Patients with congenital malformations such as hydro-encephalopathy affecting life prognosis and brain tumors.
2. Historical control group
Patients satisfying 1) described above
<Prohibited drugs>
1. Testosterone preparation (testosterone enanthate, DHT cream)
(However, adding testosterone preparations to the small penis after intervention treatment is an additional treatment and is not prohibited.)
2. hMG formulation
3. Anabolic hormone agents
4. Estrogen preparation
5. Aromatase inhibitor
6. Spironolactone
7. GnRH agonist formulation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Hasegawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Endocrinology and Metabolism
Zip code
1838561
Address
2-8-29 Musashidai, Futyu, Tokyo,Japan 183-8561
TEL
81-42-300-5111
yhaset@gmail.com
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Hasegawa |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of Endocrinology and Metabolism
Zip code
1838561
Address
2-8-29 Musashidai, Futyu, Tokyo,Japan 183-8561
TEL
81-42-300-5111
Homepage URL
yhaset@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumamoto University
Kyushu University
Kurume University
Oita University
Niigata University
Hokkaido University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai, Futyu, Tokyo,Japan 183-8561
Tel
042-300-5111 (81-423-00-5111)
yhaset@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京都立小児総合医療センター/Tokyo Metropolitan Children's Medical Center
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2026 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2027 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 04 | Day |
Last modified on
| 2022 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053711
