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

Central Precocious Puberty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278290
• Other study ID #: HNinosBuenosAires-Triptorelin
• Status: Completed
• Phase: Phase 3
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2021
• Source: Hospital de Niños R. Gutierrez de Buenos Aires
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Precocious Puberty
• Puberty, Precocious
• Sexual Precocity

Intervention

Diagnostic Test:
• Triptorelin acetate and Gonadorelin acetate
Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.
• Gonadorelin acetate and Triptorelin acetate
Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.

Locations

Country	Name	City	State
Argentina	Hospital de Niños Ricardo Gutierrez, División de Endocrinología	Ciudad Autónoma de Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Niños R. Gutierrez de Buenos Aires

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LH	Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.	3 hs
Primary	Estradiol	Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.	24 hs
Secondary	FSH	Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.	3 hs