Clinical trial NCT01944488: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Precocious Puberty
Keywords: Precocious puberty
GnRH-test
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 7
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: LH response
timeFrame: 30 minutes
Secondary outcomes:
measure: FSH response
timeFrame: 30 minutes
Other outcomes:
measure: Weight
timeFrame: Up till age 6.0 years
measure: Height
timeFrame: Up till age 6.0 years
measure: Tanner-stage (breast and pubic hair)
timeFrame: Up till age 6.0 years
measure: Bone age
timeFrame: Up till age 6.0 years
measure: Hormones (estrogen, inhibin B, SHBG, kisspeptin)
timeFrame: Up till age 6.0 years
Locations:
city: Aarhus N
country: Denmark
facility: Børneafdelingen A, AUH, Skejby
Study officials:
affiliation: Børneafdeling A, AUH, Skejby
name: Niels H. Birkebæk, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Børneafdeling A, AUH, Skejby
name: Esben T. Vestergaard, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Børneafdeling A, AUH, Skejby
name: Kurt Kristensen, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Børneafdeling A, AUH, Skejby
name: Søren Rittig, MD DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Børneafdeling A, AUH, Skejby
name: Kostas Kamperis, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Børneafdelig A, AUH, Skejby
name: Mia E. Sømod, Stud.med
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.