Long-term Outcome of GnRH Analogues Treatment of Children With Idiopathic Central Precocious Puberty (NCT02790112) | Clinical Trial Compass
UnknownNot Applicable
Long-term Outcome of GnRH Analogues Treatment of Children With Idiopathic Central Precocious Puberty
Belgium418 participantsStarted 2016-04
Plain-language summary
This study evaluates the influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of girls with idiopathic central precocious puberty.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* History of idiopathic CPP (ICPP) treated with GnRHas.
* A diagnosis of CPP made according to the following criteria: 1) secondary pubertal signs (Tanner stage 2) before 8 years in girls and 9 years in boys; 2) accelerated growth velocity (GV); 3) BA advanced for CA ≥ 1 year; 4) GnRH-stimulated peak LH \>5 IU/L.
* A diagnosis of idiopathic CPP according the following criteria: 1) no hypothalamic-pituitary organic lesions at magnetic resonance imaging; 2) no known medical condition that might affect the onset of puberty.
* To determine whether the supposed long-term effects of treatment are instead consequences of the disease itself, untreated ICPP girls aged of ≥ 18 years, will also be included. For comparative purposes, age-matched normal (menarche \> 10 y) volunteers will be recruited as a control group.
Exclusion Criteria:
* In the treated ICCP group if 1) treatment with GnRHas for \< 2 years; 2) non-compliance; 3) no gonadotropin suppression observed.
* For all patients: 4) small for gestational age; 5) chronic disease and/or treatment; 6) being \< 4 years from menarche.