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Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Hospital de Niños R. Gutierrez de Buenos Aires.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospital de Niños R. Gutierrez de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01278290
First received: January 14, 2011
Last updated: NA
Last verified: December 2010
History: No changes posted

January 14, 2011
January 14, 2011
July 2010
April 2011   (final data collection date for primary outcome measure)
  • LH [ Time Frame: 3 hs ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Same as current
No Changes Posted
FSH [ Time Frame: 3 hs ] [ Designated as safety issue: Yes ]
Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Same as current
Not Provided
Not Provided
 
Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.

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

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Central Precocious Puberty
  • Sexual Precocity
  • Drug: Triptorelin acetate and Gonadorelin acetate
    Triptorelin acetate aqueous 0.1 mg/m2 subcutaneous. Gonadorelin acetate 100 ug intravenous.
  • Drug: Gonadorelin acetate and Triptorelin acetate
    Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.
  • Active Comparator: Triptorelin test AND LHRH test
    Patients undergo two tests with a test interval of at least 15 days
    Intervention: Drug: Triptorelin acetate and Gonadorelin acetate
  • Active Comparator: LHRH test AND Triptorelin test
    Patients undergo two test with a test interval of al least 15 days.
    Intervention: Drug: Gonadorelin acetate and Triptorelin acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
October 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • premature thelarche and/or
  • accelerated growth velocity (above 90 percentile)
  • advanced bone age at least 1.5 year in relation to chronological age.

Exclusion Criteria:

  • contact with sources of exogenous estrogens in the last four months previous to evaluation,
  • suspicion of peripheral precocious puberty,
  • previous central nervous system illness or suspicion of organic central precocious puberty.
Female
3 Years to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01278290
HNinosBuenosAires-Triptorelin
Yes
Analía Freire, MD, María Gabriela Ropelato, PhD., Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina.
Hospital de Niños R. Gutierrez de Buenos Aires
Not Provided
Study Director: Maria G Ropelato, PhD División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina
Principal Investigator: Analía V Freire, MD División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina
Hospital de Niños R. Gutierrez de Buenos Aires
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP