- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01679925
Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years (PUPSY)
Qualitative Assessment of the 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.
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75019
- Assistance Publique - Hôpitaux de Paris
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial characteristics
Time Frame: 1 day
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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1 day
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Evolution at 6 months
Time Frame: 6 months
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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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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Dominique SIMON, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P111010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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