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

NCT ID: NCT01679925

Last Updated: 2015-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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

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Early Puberty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 6 to 8 years old girls, with idiopathic central precocious puberty defined as:

* Onset of clinical signs between 6 and 8 years excluded: breast development (Tanner stage S2 or more), possibly with pubic hair or accelerated growth rate.
* The GnRH test: LH peak\> 5 IU / l during the test.
* Pelvic ultrasound: uterine length\> 34 mm
* The normality of the hypothalamic-pituitary region assessed by magnetic resonance imaging (MRI).
* Parental Informed and written consent

Exclusion Criteria

* Parents and / or children do not speak French
* Other chronic disease
* The child does not benefit of the French social security cover
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominique SIMON, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Assistance Publique - Hôpitaux de Paris

Paris, Paris, France

Site Status

Countries

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France

Other Identifiers

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P111010

Identifier Type: -

Identifier Source: org_study_id

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