LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Precocious Puberty Clinical Trial

Official title:

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01944488
• Other study ID #: 1-10-72-631-12
• Status: Not yet recruiting
• Phase: N/A
• First received: September 6, 2013
• Last updated: September 12, 2013
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2013
• Source: University of Aarhus
• Contact: Niels H. Birkebæk, MD PhD
• Phone: +45 50860090
• Email: nielbirk[@]rm.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 7 Months to 6 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• GnRH agonist
100 µg/m2 body surface max 100 µg i.v.

Locations

Country	Name	City	State
Denmark	Børneafdelingen A, AUH, Skejby	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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. — View 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. — View Citation

Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J Med. 2008 May 29;358(22):2366-77. doi: 10.1056/NEJMcp0800459. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2007 Feb 6. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight		Up till age 6.0 years	No
Other	Height		Up till age 6.0 years	No
Other	Tanner-stage (breast and pubic hair)		Up till age 6.0 years	No
Other	Bone age		Up till age 6.0 years	No
Other	Hormones (estrogen, inhibin B, SHBG, kisspeptin)		Up till age 6.0 years	No
Primary	LH response		30 minutes	No
Secondary	FSH response		30 minutes	No