Early PubertyPUPSYNCT01679925
Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
An observational study of Early Puberty, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 years, women only
- Conditions the study is for
- Early Puberty
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- Women only
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- Parents and / or children do not speak French
- Other chronic disease
- The child does not benefit of the French social security cover
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Early Puberty
- Keywords
- Early puberty, Psychosocial impact, Qualitative assessment
- Medical subject headings
- Puberty, Precocious
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial characteristics
- 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.
Measured: 1 day
Secondary outcomes (2)
Child Behavior Checklist
Quantitative data on the psychosocial status of patients will be collected as a self-administered questionnaire: the Child Behavior Checklist (CBCL) that is validated.
Measured: 1 day
Evolution at 6 months
Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PubertyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique SIMON, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679925
- Sponsor's protocol ID
- P111010
- Acronym
- PUPSY
- Status last verified
- Jul 2012
- First submitted
- 25 Jul 2012
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
- ClinicalTrials.gov ID
- NCT01679925
- Acronym / sponsor ID
- PUPSY / P111010
- Conditions
- Early Puberty
- Keywords
- Early puberty, Psychosocial impact, Qualitative assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 8 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 6 to 8 years old girls, with idiopathic central precocious puberty defined as:
- Parental Informed and written consent
Key exclusion criteria (3 listed)
- Parents and / or children do not speak French
- Other chronic disease
- The child does not benefit of the French social security cover
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Child Behavior Checklist
Time frame: 1 day
Evolution at 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
Related trials for Early Puberty
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First Observatory of Precocious Puberty.
Puberty, Precocious
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Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
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Inherited Reproductive Disorders
Genetic Disorder, Infertility
Active, not recruitingPhase 3
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
Central Precocious Puberty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique SIMON, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Puberty, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial characteristics (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.