Follow-up of Girls With Premature Thelarche and Precocious Puberty

This study is not yet open for participant recruitment.
Verified September 2013 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
Mia Elbek Sømod, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01944475
First received: September 5, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

Precocious puberty - the onset of signs of puberty before 8 years of age in girls - is be physically and emotionally devastating for kids and is sometimes caused by an underlying and medical condition. One sign of precocious puberty in small girls is breast development (thelarche). This can persist without other physical changes of puberty, it may continue into precocious puberty, or it may disappear. This project will improve the diagnostics of precocious puberty in girls and improve our ability to identify which girls with thelarche, who will develop precocious puberty and need medical treatment.


Condition
Precocious Puberty
Excess; Development, Breast

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Target Follow-Up Duration: 1 Day
Official Title: Follow-up of Girls With Premature Thelarche and Precocious Puberty: a Clinical and Paraclinical Study of Girls With Thelarche and Healthy Controls

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Tanner stage (breast and pubic hair) [ Time Frame: Up till age 21.0 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight [ Time Frame: up till age 21.0 years ] [ Designated as safety issue: No ]
  • height [ Time Frame: Up till age 21.0 years ] [ Designated as safety issue: No ]
  • Bone age [ Time Frame: Up till age 21.0 years ] [ Designated as safety issue: No ]
  • LH-peak after GnRH-test [ Time Frame: Up till age 21.0 years ] [ Designated as safety issue: No ]
  • Hormones (estrogen, prolactin, 17OHP, androstrendion, DHEA, testosterone, inhibin B, SHBG, AFP, kisspeptin, HCG, thyroid hormones) [ Time Frame: Up till age 21.0 years ] [ Designated as safety issue: No ]
  • Ultrasound of the internal genitalia [ Time Frame: Up till age 21.0 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Exposure [ Time Frame: Up till age 21.0 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

GnRH test, p-estrogen, p-testosterone , p-SHBG, p- androstenedione, p-dihydroandrostendion, p-inhibin B, p-thyroid parameters, ultrasound examination of the genitalia interna and a blood sample for studies of polymorphism in the estrogen receptor gene and aromatase enzyme gene.


Estimated Enrollment: 50
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 8 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

0-6 year old girls diagnosed with premature thelarche or precocious puberty from 1998 to today at the Children's Section A, AUH, Skejby. Girls who are 8 years old or under at baseline (1st of september) will be contacted and asked to participate in a clinical and paraclinical re-examination.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of precocious puberty or premature thelarche
  • 0-6 year old girls at time of diagnosis for the medical record review
  • 0-8 year old girls at baseline for the re-examination

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01944475

Contacts
Contact: Niels H Birkebæk, Dr.med, PhD +45 50860090 nielbirk@rm.dk
Contact: Mia E Sømod, Stud. med +45 60199810 mia.elbek.somod@studmed.au.dk

Locations
Denmark
Børneafdelingen A, AUH, Skejby Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Niels H. Birkebæk, Dr.med, PhD    +45 50860090    nielbirk@rm.dk   
Contact: Mia E. Sømod, Stud.med    45 60199810    mia.elbek.somod@studmed.au.dk   
Principal Investigator: Niels H. Birkebæk, MD PhD         
Principal Investigator: Esben T. Vestergaard, MD PhD         
Principal Investigator: Kurt Kristensen, MD PhD         
Principal Investigator: Mia E. Sømod, Stud.med         
Børneafdelingen A, AUH, Skejby Not yet recruiting
Aarhus N, Denmark, 8200
Contact: Niels H. Birkebæk, Dr.med, PhD    +4550860090    nielbirk@rm.dk   
Contact: Mia E. Sømod, Stud.med    +4560199810    mia.elbek.somod@studmed.au.dk   
Principal Investigator: Niels H. Birkebæk, Dr.med, PhD         
Principal Investigator: Esben T. Vestergaard, Dr.med, PhD         
Principal Investigator: Kurt Kristensen, Dr.med, PhD         
Principal Investigator: Mia E. Sømod, Stud.med         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital Skejby
Investigators
Principal Investigator: Niels H. Birkebæk, MD PhD Børneafdeling A, AUH, Skejby
Principal Investigator: Esben T. Vestergaard, MD, PhD Børneafdeling A, AUH, Skejby
Principal Investigator: Kurt Kristensen, MD, PhD Børneafdeling A, AUH, Skejby
Principal Investigator: Mia E. Sømod, Stud.med Børneafdeligen A, AUH, Skejby
  More Information

Publications:

Responsible Party: Mia Elbek Sømod, Research assistamt, University of Aarhus
ClinicalTrials.gov Identifier: NCT01944475     History of Changes
Other Study ID Numbers: 1-10-72-186-13
Study First Received: September 5, 2013
Last Updated: September 12, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Precocious puberty
Premature thelarche
Tanner-stage
GnRH-test

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014