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CompletedNCT01679925

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
Female
Age
6 Years – 8 Years
Healthy volunteers
Not accepted

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.

Detailed 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).

Conditions

Timeline

Start date
2012-10-01
Primary completion
2014-07-01
Completion
2015-02-01
First posted
2012-09-06
Last updated
2015-03-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01679925. Inclusion in this directory is not an endorsement.

Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years (NCT01679925) · Clinical Trials Directory