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LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Primary Purpose

Precocious Puberty

Status

Unknown status

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

GnRH agonist

About this trial

This is an interventional diagnostic trial for Precocious Puberty focused on measuring Precocious puberty, GnRH-test

Eligibility Criteria

7 Months - 6 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Børneafdelingen A, AUH, Skejby

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GnRH intervention

Arm Description

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

Outcomes

Primary Outcome Measures

LH response

Secondary Outcome Measures

FSH response

Full Information

NCT ID

NCT01944488

First Posted

September 6, 2013

Last Updated

September 12, 2013

Sponsor

University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT01944488

Brief Title

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Official Title

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2013 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Please refer to the brief summary which covers the study aim, methods and outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Precocious Puberty

Keywords

Precocious puberty, GnRH-test

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GnRH intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GnRH agonist

Other Intervention Name(s)

LHRH agonist

Intervention Description

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

Primary Outcome Measure Information:

Title

LH response

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

FSH response

Time Frame

30 minutes

Other Pre-specified Outcome Measures:

Title

Weight

Time Frame

Up till age 6.0 years

Title

Height

Time Frame

Up till age 6.0 years

Title

Tanner-stage (breast and pubic hair)

Time Frame

Up till age 6.0 years

Title

Bone age

Time Frame

Up till age 6.0 years

Title

Hormones (estrogen, inhibin B, SHBG, kisspeptin)

Time Frame

Up till age 6.0 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

7 Months

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Niels H. Birkebæk, MD PhD

Phone

+45 50860090

nielbirk@rm.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Mia E. Sømod, Stud. med

Phone

+45 60199810

mia.elbek.somod@studmed.au.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Niels H. Birkebæk, MD PhD

Organizational Affiliation

Børneafdeling A, AUH, Skejby

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Esben T. Vestergaard, MD PhD

Organizational Affiliation

Børneafdeling A, AUH, Skejby

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kurt Kristensen, MD PhD

Organizational Affiliation

Børneafdeling A, AUH, Skejby

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Søren Rittig, MD DMSc

Organizational Affiliation

Børneafdeling A, AUH, Skejby

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kostas Kamperis, MD PhD

Organizational Affiliation

Børneafdeling A, AUH, Skejby

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mia E. Sømod, Stud.med

Organizational Affiliation

Børneafdelig A, AUH, Skejby

Official's Role

Principal Investigator

Facility Information:

Facility Name

Børneafdelingen A, AUH, Skejby

City

Aarhus N

ZIP/Postal Code

8200

Country

Denmark

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Niels H. Birkebæk, Dr.med, PhD

Phone

+45 50860090

nielbirk@rm.dk

First Name & Middle Initial & Last Name & Degree

Mia E. Sømod, Stud.med

Phone

+45 60199810

mia.elbek.somod@studmed.au.dk

First Name & Middle Initial & Last Name & Degree

Niels H. Birkebæk, MD PhD

First Name & Middle Initial & Last Name & Degree

Esben T. Vestergaard, MD PhD

First Name & Middle Initial & Last Name & Degree

Kurt Kristensen, MD PhD

First Name & Middle Initial & Last Name & Degree

Søren Rittig, MD DMSc

First Name & Middle Initial & Last Name & Degree

Kostas Kamperis, MD PhD

First Name & Middle Initial & Last Name & Degree

Mia E. Sømod, Stud.med

12. IPD Sharing Statement

Citations:

PubMed Identifier

18509122

Citation

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.

Results Reference

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PubMed Identifier

16322154

Citation

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.

Results Reference

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PubMed Identifier

9093289

Citation

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.

Results Reference

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PubMed Identifier

19189683

Citation

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.

Results Reference

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PubMed Identifier

22099730

Citation

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.

Results Reference

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PubMed Identifier

21854448

Citation

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.

Results Reference

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PubMed Identifier

19914634

Citation

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.

Results Reference

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PubMed Identifier

17284632

Citation

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.

Results Reference

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PubMed Identifier

10522992

Citation

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.

Results Reference

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LH Response to GnRH Test in Prepubescent Girls Under 6 Years

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