ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow-up of Girls With Premature Thelarche and Precocious Puberty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01944475
Recruitment Status : Unknown
Verified September 2013 by Mia Elbek Sømod, University of Aarhus.
Recruitment status was:  Not yet recruiting
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
Sponsor:
Collaborator:
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
Mia Elbek Sømod, University of Aarhus

Brief Summary:
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 or disease
Precocious Puberty Excess; Development, Breast

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
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
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014





Primary Outcome Measures :
  1. Tanner stage (breast and pubic hair) [ Time Frame: Up till age 21.0 years ]

Secondary Outcome Measures :
  1. weight [ Time Frame: up till age 21.0 years ]
  2. height [ Time Frame: Up till age 21.0 years ]
  3. Bone age [ Time Frame: Up till age 21.0 years ]
  4. LH-peak after GnRH-test [ Time Frame: Up till age 21.0 years ]
  5. Hormones (estrogen, prolactin, 17OHP, androstrendion, DHEA, testosterone, inhibin B, SHBG, AFP, kisspeptin, HCG, thyroid hormones) [ Time Frame: Up till age 21.0 years ]
  6. Ultrasound of the internal genitalia [ Time Frame: Up till age 21.0 years ]

Other Outcome Measures:
  1. Exposure [ Time Frame: Up till age 21.0 years ]

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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 8 Years   (Child)
Sexes 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:


Information from the National Library of Medicine

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): 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

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
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Premature Birth
Puberty, Precocious
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gonadal Disorders
Endocrine System Diseases