NCT01679925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 26, 2015

Status Verified

July 1, 2012

Enrollment Period

1.7 years

First QC Date

July 25, 2012

Last Update Submit

March 25, 2015

Conditions

Early Puberty

Keywords

Early pubertyPsychosocial impactQualitative assessment

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (2)

  • Child Behavior Checklist

    1 day

  • Evolution at 6 months

    6 months

Eligibility Criteria

Age6 Years - 8 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Parents and / or children do not speak French
  • Other chronic disease
  • The child does not benefit of the French social security cover

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Paris, Paris, 75019, France

Location

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Dominique SIMON, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

September 6, 2012

Study Start

October 1, 2012

Primary Completion

July 1, 2014

Study Completion

February 1, 2015

Last Updated

March 26, 2015

Record last verified: 2012-07

Locations

FR(1)