Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years — PUPSY  

Early Puberty Clinical Trial

Official title: Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years

Status Completed

Clinical Trial Summary

GnRH agonists are used in the treatment of precocious puberty in order to improve adult height.However,the psychosocial impact of precocious puberty is often used by the clinician at diagnosis to justify treatment, but can not yet be properly assessed. It can not be considered as a rational neither for the indication to treatment, nor to assess its potential efficacy.

The overall objective of this work is to improve the conditions leading to the therapeutic decision and the procedures for monitoring girls with idiopathic central precocious puberty.

Clinical Trial Description

During the day hospital, the diagnostic workup for precocious puberty will be performed and include:

• A clinical examination with pubertal stage assessment.

• A GnRH test

• A Pelvic ultrasound

• An MRI will be performed later after the results of GnRH test confirming precocious central puberty.

These reviews are conducted as part of usual care and are required to validate the inclusion criteria of patients.

The CBCL questionnaire will be completed by patient's parents and the first semi-structured interview will be conducted by a sociologist assisted by the psychologist, dedicated to the study.

Patient's follow-up will be planned 6 months after inclusion, including similar investigations (except MRI). ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Puberty
• Puberty, Precocious

• NCT number: NCT01679925
• Study type: Observational
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Completion date: February 2015