Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years (PUPSY)
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ClinicalTrials.gov Identifier: NCT01679925 |
Recruitment Status :
Completed
First Posted : September 6, 2012
Last Update Posted : March 26, 2015
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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.
Condition or disease |
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Early Puberty |
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 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 |

- 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.
- 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.
- 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.

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Ages Eligible for Study: | 6 Years to 8 Years (Child) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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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

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 ClinicalTrials.gov identifier (NCT number): NCT01679925
France | |
Assistance Publique - Hôpitaux de Paris | |
Paris, France, 75019 |
Principal Investigator: | Dominique SIMON, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov 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 |
Early puberty Psychosocial impact Qualitative assessment |
Puberty, Precocious Gonadal Disorders Endocrine System Diseases |