NCT01944475

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

1 year

First QC Date

September 5, 2013

Last Update Submit

September 12, 2013

Conditions

Precocious PubertyExcess; Development, Breast

Keywords

Precocious pubertyPremature thelarcheTanner-stageGnRH-test

Outcome Measures

Primary Outcomes (1)

  • Tanner stage (breast and pubic hair)

    Up till age 21.0 years

Secondary Outcomes (6)

  • weight

    up till age 21.0 years

  • height

    Up till age 21.0 years

  • Bone age

    Up till age 21.0 years

  • LH-peak after GnRH-test

    Up till age 21.0 years

  • Hormones (estrogen, prolactin, 17OHP, androstrendion, DHEA, testosterone, inhibin B, SHBG, AFP, kisspeptin, HCG, thyroid hormones)

    Up till age 21.0 years

  • +1 more secondary outcomes

Other Outcomes (1)

  • Exposure

    Up till age 21.0 years

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Børneafdelingen A, AUH, Skejby

Aarhus N, 8200, Denmark

Location

Børneafdelingen A, AUH, Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (10)

  • Carel JC, Leger J. Clinical practice. Precocious puberty. N Engl J Med. 2008 May 29;358(22):2366-77. doi: 10.1056/NEJMcp0800459. No abstract available.

    PMID: 18509122BACKGROUND

  • Carel JC, Lahlou N, Roger M, Chaussain JL. Precocious puberty and statural growth. Hum Reprod Update. 2004 Mar-Apr;10(2):135-47. doi: 10.1093/humupd/dmh012.

    PMID: 15073143BACKGROUND

  • Tremblay L, Frigon JY. Precocious puberty in adolescent girls: a biomarker of later psychosocial adjustment problems. Child Psychiatry Hum Dev. 2005 Fall;36(1):73-94. doi: 10.1007/s10578-004-3489-2.

    PMID: 16049645BACKGROUND

  • Michaud PA, Suris JC, Deppen A. Gender-related psychological and behavioural correlates of pubertal timing in a national sample of Swiss adolescents. Mol Cell Endocrinol. 2006 Jul 25;254-255:172-8. doi: 10.1016/j.mce.2006.04.037. Epub 2006 Jun 27.

    PMID: 16806671BACKGROUND

  • Herman-Giddens ME, Slora EJ, Wasserman RC, Bourdony CJ, Bhapkar MV, Koch GG, Hasemeier CM. Secondary sexual characteristics and menses in young girls seen in office practice: a study from the Pediatric Research in Office Settings network. Pediatrics. 1997 Apr;99(4):505-12. doi: 10.1542/peds.99.4.505.

    PMID: 9093289BACKGROUND

  • Teilmann G, Pedersen CB, Jensen TK, Skakkebaek NE, Juul A. Prevalence and incidence of precocious pubertal development in Denmark: an epidemiologic study based on national registries. Pediatrics. 2005 Dec;116(6):1323-8. doi: 10.1542/peds.2005-0012.

    PMID: 16322154BACKGROUND

  • Houk CP, Kunselman AR, Lee PA. The diagnostic value of a brief GnRH analogue stimulation test in girls with central precocious puberty: a single 30-minute post-stimulation LH sample is adequate. J Pediatr Endocrinol Metab. 2008 Dec;21(12):1113-8. doi: 10.1515/jpem.2008.21.12.1113.

    PMID: 19189683BACKGROUND

  • Curfman AL, Reljanovic SM, McNelis KM, Dong TT, Lewis SA, Jackson LW, Cromer BA. Premature thelarche in infants and toddlers: prevalence, natural history and environmental determinants. J Pediatr Adolesc Gynecol. 2011 Dec;24(6):338-41. doi: 10.1016/j.jpag.2011.01.003.

    PMID: 22099730BACKGROUND

  • Atay Z, Turan S, Guran T, Furman A, Bereket A. The prevalence and risk factors of premature thelarche and pubarche in 4- to 8-year-old girls. Acta Paediatr. 2012 Feb;101(2):e71-5. doi: 10.1111/j.1651-2227.2011.02444.x. Epub 2011 Sep 23.

    PMID: 21854448BACKGROUND

  • de Vries L, Guz-Mark A, Lazar L, Reches A, Phillip M. Premature thelarche: age at presentation affects clinical course but not clinical characteristics or risk to progress to precocious puberty. J Pediatr. 2010 Mar;156(3):466-71. doi: 10.1016/j.jpeds.2009.09.071. Epub 2009 Nov 14.

    PMID: 19914634BACKGROUND

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.

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels H Birkebæk, Dr.med, PhD

CONTACT

+45 50860090nielbirk@rm.dk

Mia E Sømod, Stud. med

CONTACT

+45 60199810mia.elbek.somod@studmed.au.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistamt

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 17, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

DK(2)