NCT01278290

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

January 14, 2011

Last Update Submit

January 4, 2021

Conditions

Central Precocious PubertySexual Precocity

Keywords

Triptorelin acetateprecocious pubertypremature thelarcheGnRH analogDiagnostic validation study

Outcome Measures

Primary Outcomes (2)

  • LH

    Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.

    3 hs

  • Estradiol

    Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.

    24 hs

Secondary Outcomes (1)

  • FSH

    3 hs

Study Arms (2)

Triptorelin test AND LHRH test

ACTIVE COMPARATOR

Patients undergo two tests with a test interval of at least 15 days

Diagnostic Test: Triptorelin acetate and Gonadorelin acetate

LHRH test AND Triptorelin test

ACTIVE COMPARATOR

Patients undergo two test with a test interval of al least 15 days.

Diagnostic Test: Gonadorelin acetate and Triptorelin acetate

Interventions

Triptorelin acetate and Gonadorelin acetateDIAGNOSTIC_TEST

Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.

Triptorelin test AND LHRH test
Gonadorelin acetate and Triptorelin acetateDIAGNOSTIC_TEST

Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.

LHRH test AND Triptorelin test

Eligibility Criteria

Age3 Years - 8 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Niños Ricardo Gutierrez, División de Endocrinología

Buenos Aires, C1425SEFD, Argentina

Location

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Maria G Ropelato, PhD

    División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina

    STUDY DIRECTOR

  • Analía V Freire, MD

    División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Endocrinology, PhD

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 17, 2011

Study Start

December 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

AR(1)