Male hypogonadotropic hypogonadism
Conditions
Interventions
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) Subcutaneou
Sponsors
Tokyo Metropolitan Children's Medical Center
Kumamoto University Kyushu University Kurume University Oita University Niigata University Hokkaido University
Eligibility
Sex/Gender
Male
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in penile length at the end of observation period, compared with pretreatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactYukihiro Hasegawa
Tokyo Metropolitan Children's Medical Center Division of Endocrinology and Metabolism
Outcome results
None listed