Precocious Puberty, Gonadotropin-dependent Clinical Trial
Official title:
Urinary LH in the Diagnosis of Precocious Puberty
Precocious puberty (PP) in girls is classically defined by the onset of secondary sexual
characteristics before eight years of age, but subsequent pubertal maturation can be quite
varied. In many girls, PP takes a rapid course of progression (rapidly progressive
precocious puberty; RP-PP) with an early menarche and fusion of the epiphyseal growth
plates, leading eventually to a reduced final height if not treated. In a subset of girls
with PP however, the growth rate slows to normal for age, skeletal maturation progresses in
accordance with chronological age and there is little to no risk of impairment of final
height (slowly progressive precocious puberty; SP-PP). Other conditions of non-progressive
PP include premature breast budding and unsustained PP that is characterized by a
spontaneous regression of sexual precocity. Due to their benign course, slowly progressive
(SP) PP and other non-progressive forms of PP do not warrant therapy with GnRH agonists.
Differentiating these forms from RP-PP is therefore essential to prevent unnecessary
intervention in a population that accounts for at least 50% of girls with PP. A distinction
between these forms of PP may be difficult on clinical grounds however, since all these
patients may present initially as isolated breast development.
The gold standard for the diagnosis of true (central) PP is the measurement of gonadotropins
following GnRH stimulation test. There is however an overlap between prepubertal and early
pubertal values and between girls with premature breast budding and progressive PP. It was
suggested therefore that progressive pubertal development and growth acceleration should be
documented over a 3- to 6-months period before GnRHa therapy in initiated.
More than a decade ago several studies demonstrated that urinary gonadotropins are age
related and significantly increased during puberty. It has been suggested that urinary
gonadotropins measurements can be used for differential diagnosis of pubertal disorders.
This is based on the assumption that gradual elevation of nocturnal LH secretion prior to
and at the onset of puberty can be reflected by first-voided urinary LH (ULH). In this
prospective study, the investigators aimed to evaluate the value of first-voided ULH
measurements in predicting pubertal course and differentiating SP-PP from RP-PP, by
comparison to GnRH-stimulated gonadotropins.
| Status | Recruiting |
| Enrollment | 65 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 9 Years |
| Eligibility |
Inclusion Criteria: - Onset of puberty after 3 years of age in boys and girls - Onset of puberty before 8 years in girls and 9 years in boys Exclusion Criteria: - Non-central precocious puberty - Congenital adrenal hyperplasia - Enuresis nocturne |
Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Israel | Peditaric Endocrinology Unit, Kaplan Medical Center | Rehovot |
| Lead Sponsor | Collaborator |
|---|---|
| Amnon Zung |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Identification of first-voided urinary LH cutoff for differentiating pseudothelarche from true breast budding, compared with GnRH stimulated gonadotropins | 2 years | No | |
| Primary | Identification of first-voided urinary LH cutoff for the detection of pubertal advancement by comparison with GnRH stimulated gonadotropins | 2 years | No | |
| Secondary | Levels first-voided urinary LH measurements in monitoring gonadotropin suppression during GnRHa therapy | 2 years | No |