Clinical Trial: Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.

Brief Summary:

The aim of the study is to determine the specificity, sensitivity and diagnostic efficiency of the Triptorelin Test in the assessment of CPP compared to GnRH test as gold standard.

Hypothesis: Aqueous Triptorelin Acetate is so efficient as GnRH to CPP assessment.

Study population are girls with suspicious clinical features of precocious puberty

Detailed Summary: GnRH stimulation is the gold standard to distinguish between isolated premature thelarche (PT) and CPP. However, intravenous GnRH for testing is not fully available in all countries. To evaluate the diagnostic accuracy of a novel Triptorelin-test in the assessment of CPP compared to the GnRH test, a validation study was performed. Girls who presented thelarche with accelerated growth and/or advanced bone age were included. All girls underwent the two tests in a randomized order. CPP was ascertained according to LH response under GnRH (gold standard test).
Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Current Primary Outcome:

• LH [ Time Frame: 3 hs ]
  Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
• Estradiol [ Time Frame: 24 hs ]
  Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.

Original Primary Outcome: Same as current

Current Secondary Outcome: FSH [ Time Frame: 3 hs ]

Original Secondary Outcome: Same as current

Information By: Hospital de Niños R. Gutierrez de Buenos Aires

Dates:
Date Received: January 14, 2011
Date Started: July 2010
Date Completion: October 2011
Last Updated: January 14, 2011
Last Verified: December 2010