Constitutional Delay of Growth and Puberty
Conditions
Keywords
Puberty, Constitutional, Delay, Letrozole, Testosterone
Brief summary
Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based effective and safe treatment option. This study compares the effects of low-dose testosterone and aromatase inhibitor letrozole on pubertal progression. The hypothesis is that, in boys CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo) induces faster biochemical and clinical progression of puberty as compared to low-dose intramuscular testosterone Rx (\ 1mg/kg/mo for 6 mo). In addition, 10 or more boys who select watchful waiting instead of medication will provide background data on the natural progression of CDGP, and their data will not be used in primary statistical comparisons.
Interventions
DRUGTestosterone
1mg/kg every 4 weeks for 6 months
DRUGLetrozole
2.5mg daily for 6 months. Safety criteria: if testosterone level is above 30nM at 3 months, the dosage is reduced to 2.5mg every other day
Sponsors
Foundation for Paediatric Research, Finland
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
14 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Constitutional delay of growth and puberty * Age 14 years or more * mean testicular volume 2.5 ml or more and less than 4 ml * serum testosterone level less than 5 nM OR as above, but serum testosterone 1 nM or more with normal DHEAS level, even if the mean testicular volume is less than 2.5 ml OR as above, but tanner stage G2 and testosterone level less than 3 nM
Exclusion criteria
* Chronic diseases * Primary or secondary hypogonadism * Chromosomal anomalies * Chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| testicular volume | one year | Testes will be measured with a ruler to the nearest millimeter and volume will be calculated at 0, 6, and 12 mo |
| clinical and biochemical measures of pubertal progression | one year | Activity of the hypothalamic-pituitary-gonadal axis, evaluated by * genital and pubic hair stage of puberty according to Tanner; * growth velocity (cm/yr); * basal and gonadotropin-releasing hormone (GnRH)-stimulated gonadotropin levels; * urinary luteinizing hormone levels; * testosterone; * inhibin B; * anti-mullerian hormone (AMH) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone health | one year | Several endpoints related to bone health |
| Psychosocial well-being | one year | Psycho-social well-being will assessed with questionnaires. |
| Puberty-related metabolical and clinical changes | one year | Biochemical and metabolical changes will be compared btw testosterone and letrozole treatment groups. |
Countries
Finland
Outcome results
None listed