NCT01944488

Brief Summary

The project aims to establish the normal LH and FSH response to a standardized GnRH dose in healthy girls below 6 years of age, and compares the normal GnRH response to the GnRH response in girls with early puberty development. The novel data may help to determine whether the girl is in early puberty or not. Healthy girls under 6 years of age attending routine examinations including an i.v. line for other causes are included in this study. Our examinations also include bone age determination, Tanner stage determination, and anthropometric measures (height and weight). 10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36 months, 36-48 months, 48-60 months and 60-72 months are included.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

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
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed
11 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 6, 2013

Last Update Submit

September 12, 2013

Conditions

Precocious Puberty

Keywords

Precocious pubertyGnRH-test

Outcome Measures

Primary Outcomes (1)

  • LH response

    30 minutes

Secondary Outcomes (1)

  • FSH response

    30 minutes

Other Outcomes (5)

  • Weight

    Up till age 6.0 years

  • Height

    Up till age 6.0 years

  • Tanner-stage (breast and pubic hair)

    Up till age 6.0 years

  • +2 more other outcomes

Study Arms (1)

GnRH intervention

EXPERIMENTAL

All participating subjects are assigned to receive an intravenous GnRH agonist injection.

Drug: GnRH agonist

Interventions

GnRH agonistDRUG

100 µg/m2 body surface max 100 µg i.v.

Also known as: LHRH agonist
GnRH intervention

Eligibility Criteria

Age7 Months - 6 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Endocrinologically healthy girls in the age from 7 months to 6 years
  • Obtained oral and written informed consent from participants parents

You may not qualify if:

  • Anamnestic, clinical or laboratory findings that indicate that the subject is suffering from other diseases (eg poorly controlled asthma) or is in a condition which might affect the subject's ability to complete the study or which is likely to affect the parameters under investigation.
  • Current medical treatment apart from prophylactic antibiotics or weak analgesics.
  • GFR \<50 ml/min/1,73m2 or if absence of previous GFR study: serum creatinine above normal upper age-specific normal range.
  • Clinical signs of precocious puberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Børneafdelingen A, AUH, Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (9)

  • 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

  • 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

  • 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

  • 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

  • Resende EA, Lara BH, Reis JD, Ferreira BP, Pereira GA, Borges MF. Assessment of basal and gonadotropin-releasing hormone-stimulated gonadotropins by immunochemiluminometric and immunofluorometric assays in normal children. J Clin Endocrinol Metab. 2007 Apr;92(4):1424-9. doi: 10.1210/jc.2006-1569. Epub 2007 Feb 6.

    PMID: 17284632BACKGROUND

  • Brito VN, Batista MC, Borges MF, Latronico AC, Kohek MB, Thirone AC, Jorge BH, Arnhold IJ, Mendonca BB. Diagnostic value of fluorometric assays in the evaluation of precocious puberty. J Clin Endocrinol Metab. 1999 Oct;84(10):3539-44. doi: 10.1210/jcem.84.10.6024.

    PMID: 10522992BACKGROUND

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

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

  • Søren Rittig, MD DMSc

    Børneafdeling A, AUH, Skejby

    PRINCIPAL INVESTIGATOR

  • Kostas Kamperis, MD PhD

    Børneafdeling A, AUH, Skejby

    PRINCIPAL INVESTIGATOR

  • Mia E. Sømod, Stud.med

    Børneafdelig A, AUH, Skejby

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels H. Birkebæk, MD PhD

CONTACT

+45 50860090nielbirk@rm.dk

Mia E. Sømod, Stud. med

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 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(1)