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Completed

NCT Number: NCT01679925

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

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.

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Key information

Age range

6 year–8 year

Sex eligibility

Female

Study type

Observational

Primary location

Assistance Publique - Hôpitaux de Paris

Paris, 75019, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Psychosocial characteristics

    Time frame: 1 day

    • The thematic content related to the perception of early puberty, the factors motivating the consultation, the concerns of families and children, psychosocial characteristics of the subjects received in consultation.
    • The thematic content related to the perception of hormone therapy: identifying the knowledge, concerns and expectations regarding the treatment of precocious puberty.

Secondary outcomes

  1. Child Behavior Checklist

    Time frame: 1 day

    Quantitative data on the psychosocial status of patients will be collected as a self-administered questionnaire: the Child Behavior Checklist (CBCL) that is validated.

  2. Evolution at 6 months

    Time frame: 6 months

    Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PUPSY

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Sep 6, 2012
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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