MedDataX Logo

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

NCT ID: NCT01944488

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Precocious Puberty

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Precocious puberty GnRH-test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GnRH intervention

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

Group Type EXPERIMENTAL

GnRH agonist

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GnRH agonist

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LHRH agonist

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

7 Months

Maximum Eligible Age

6 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Niels H. Birkebæk, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Børneafdeling A, AUH, Skejby

Esben T. Vestergaard, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Børneafdeling A, AUH, Skejby

Kurt Kristensen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Børneafdeling A, AUH, Skejby

Søren Rittig, MD DMSc

Role: PRINCIPAL_INVESTIGATOR

Børneafdeling A, AUH, Skejby

Kostas Kamperis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Børneafdeling A, AUH, Skejby

Mia E. Sømod, Stud.med

Role: PRINCIPAL_INVESTIGATOR

Børneafdelig A, AUH, Skejby

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Børneafdelingen A, AUH, Skejby

Aarhus N, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Niels H. Birkebæk, MD PhD

Role: CONTACT

Phone: +45 50860090

Email: [email protected]

Mia E. Sømod, Stud. med

Role: CONTACT

Phone: +45 60199810

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Niels H. Birkebæk, Dr.med, PhD

Role: primary

Mia E. Sømod, Stud.med

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18509122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16322154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9093289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19189683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22099730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21854448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19914634 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17284632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10522992 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-10-72-631-12

Identifier Type: -

Identifier Source: org_study_id