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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. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Hospital de Niños R. Gutierrez de Buenos Aires.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278290
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Niños R. Gutierrez de Buenos Aires
  Purpose

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


Condition Intervention Phase
Central Precocious Puberty Sexual Precocity Drug: Triptorelin acetate and Gonadorelin acetate Drug: Gonadorelin acetate and Triptorelin acetate Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.

Resource links provided by NLM:


Further study details as provided by Hospital de Niños R. Gutierrez de Buenos Aires:

Primary Outcome Measures:
  • 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.


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


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Triptorelin test AND LHRH test
Patients undergo two tests with a test interval of at least 15 days
Drug: Triptorelin acetate and Gonadorelin acetate
Triptorelin acetate aqueous 0.1 mg/m2 subcutaneous. Gonadorelin acetate 100 ug intravenous.
Active Comparator: LHRH test AND Triptorelin test
Patients undergo two test with a test interval of al least 15 days.
Drug: Gonadorelin acetate and Triptorelin acetate
Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.

Detailed 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).
  Eligibility

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278290


Locations
Argentina
Hospital de Niños Ricardo Gutierrez, División de Endocrinología
Ciudad Autónoma de Buenos Aires, Argentina, C1425SEFD
Sponsors and Collaborators
Hospital de Niños R. Gutierrez de Buenos Aires
Investigators
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
  More Information

Responsible Party: Analía Freire, MD, María Gabriela Ropelato, PhD., Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina.
ClinicalTrials.gov Identifier: NCT01278290     History of Changes
Other Study ID Numbers: HNinosBuenosAires-Triptorelin
First Submitted: January 14, 2011
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
Last Verified: December 2010

Keywords provided by Hospital de Niños R. Gutierrez de Buenos Aires:
Triptorelin acetate
precocious puberty
premature thelarche
GnRH analog
Diagnostic validation study

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents