COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01679925
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease
Early 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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
Study Start Date : October 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : February 2015

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be offered to all children and families who visit in a day hospital in the pediatric endocrinology department of Robert Debré Hospital for further assessment of early puberty.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01679925

Layout table for location information
Assistance Publique - Hôpitaux de Paris
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Layout table for investigator information
Principal Investigator: Dominique SIMON, MD, PhD Assistance Publique - Hôpitaux de Paris
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01679925    
Other Study ID Numbers: P111010
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: July 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Early puberty
Psychosocial impact
Qualitative assessment
Additional relevant MeSH terms:
Layout table for MeSH terms
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases