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Follow-up of Girls With Premature Thelarche and Precocious Puberty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by University of Aarhus.
Recruitment status was:  Not yet recruiting
Aarhus University Hospital Skejby
Information provided by (Responsible Party):
Mia Elbek Sømod, University of Aarhus Identifier:
First received: September 5, 2013
Last updated: September 12, 2013
Last verified: September 2013
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.

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 ]

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

Other Outcome Measures:
  • 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.

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


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.

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01944475

Børneafdelingen A, AUH, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital Skejby
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, Børneafdeligen A, AUH, Skejby
  More Information


Responsible Party: Mia Elbek Sømod, Research assistamt, University of Aarhus 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

Keywords provided by University of Aarhus:
Precocious puberty
Premature thelarche

Additional relevant MeSH terms:
Premature Birth
Puberty, Precocious
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Gonadal Disorders
Endocrine System Diseases processed this record on February 20, 2017