LH Response to GnRH Test in Prepubescent Girls Under 6 Years

September 12, 2013 updated by: University of Aarhus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Børneafdelingen A, AUH, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GnRH intervention
All participating subjects are assigned to receive an intravenous GnRH agonist injection.
Drug: GnRH agonist
100 µg/m2 body surface max 100 µg i.v.
Other Names:
  • LHRH agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LH response
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
FSH response
Time Frame: 30 minutes
30 minutes

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Niels H. Birkebæk, MD PhD, Børneafdeling A, AUH, Skejby
  • Principal Investigator: Esben T. Vestergaard, MD PhD, Børneafdeling A, AUH, Skejby
  • Principal Investigator: Kurt Kristensen, MD PhD, Børneafdeling A, AUH, Skejby
  • Principal Investigator: Søren Rittig, MD DMSc, Børneafdeling A, AUH, Skejby
  • Principal Investigator: Kostas Kamperis, MD PhD, Børneafdeling A, AUH, Skejby
  • Principal Investigator: Mia E. Sømod, Stud.med, Børneafdelig A, AUH, Skejby

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

September 6, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 17, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-631-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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