A study on infantile gonadotropin treatment for male hypogonadotropic hypogonadism
Not Applicable
Recruiting
- Conditions
- Male hypogonadotropic hypogonadism
- Registration Number
- JPRN-UMIN000047088
- Lead Sponsor
- Tokyo Metropolitan Children's Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 40
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in penile length at the end of observation period, compared with pretreatment period
- Secondary Outcome Measures
Name Time Method 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