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
Recruitment status was Active, not recruiting
Sponsor:
Hospital de Niños R. Gutierrez de Buenos Aires
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
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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:
Genetics Home Reference related topics:
familial male-limited precocious puberty
MedlinePlus related topics:
Puberty
U.S. FDA Resources
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
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 May 16, 2013