LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01944488

Enrollment

Registered

2013-09-17

Start date

2013-09-30

Completion date

2014-09-30

Last updated

2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precocious Puberty

Keywords

Precocious puberty, GnRH-test

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.

Interventions

DRUGGnRH agonist

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

7 Months to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
LH response	30 minutes

Secondary

Measure	Time frame
FSH response	30 minutes

Other

Measure	Time frame
Tanner-stage (breast and pubic hair)	Up till age 6.0 years
Weight	Up till age 6.0 years
Hormones (estrogen, inhibin B, SHBG, kisspeptin)	Up till age 6.0 years
Bone age	Up till age 6.0 years
Height	Up till age 6.0 years

Countries

Denmark

Contacts

Primary ContactNiels H. Birkebæk, MD PhD

nielbirk@rm.dk+45 50860090

Backup ContactMia E. Sømod, Stud. med

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026