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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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.


Secondary Outcome Measures:
  • 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.


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

Ages Eligible for Study:   3 Years to 8 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 14, 2011
Last Updated: January 14, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

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
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014