LH Response to GnRH Test in Prepubescent Girls Under 6 Years

N/AUnknownNCT01944488

University of Aarhus60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Precocious Puberty

Interventions

Eligibility

Sex: FEMALEMin age: 7 MonthsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 Contacts

Niels H. Birkebæk, MD PhD

CONTACT

+45 50860090 nielbirk@rm.dk

Mia E. Sømod, Stud. med

CONTACT

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

LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts