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LH Response to GnRH Test in Prepubescent Girls Under 6 Years

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by University of Aarhus.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: September 6, 2013
Last updated: September 12, 2013
Last verified: September 2013

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.

Condition Intervention
Precocious Puberty
Drug: GnRH agonist

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: LH Response to GnRH Test in Prepubescent Girls Under 6 Years

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • LH response [ Time Frame: 30 minutes ]

Secondary Outcome Measures:
  • FSH response [ Time Frame: 30 minutes ]

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

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: LHRH agonist

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

Ages Eligible for Study:   7 Months to 6 Years   (Child)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01944488

Børneafdelingen A, AUH, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
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, Børneafdelig A, AUH, Skejby
  More Information


Responsible Party: University of Aarhus Identifier: NCT01944488     History of Changes
Other Study ID Numbers: 1-10-72-631-12 
Study First Received: September 6, 2013
Last Updated: September 12, 2013

Keywords provided by University of Aarhus:
Precocious puberty

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on February 17, 2017