Central Precocious PubertyPhase 3NCT01278290
Comparative Validation of the Triptorelin Test for the Diagnosis of CPP in Girls
A Phase 3 study testing Triptorelin acetate and Gonadorelin acetate and Gonadorelin acetate and Triptorelin acetate in people with Central Precocious Puberty and Sexual Precocity, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 years, women only
- Conditions the study is for
- Central Precocious Puberty, Sexual Precocity
- What is being tested?
- Triptorelin acetate and Gonadorelin acetate and Gonadorelin acetate and Triptorelin acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteArgentina
- Study dates
- Dec 2009to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- premature thelarche and/or
- accelerated growth velocity (above 90 percentile)
- advanced bone age at least 1.5 year in relation to chronological age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital de Niños Ricardo Gutierrez, División de Endocrinología
Buenos Aires, C1425SEFD
About this study
Official title: Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.
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
Read the 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).
- Conditions
- Central Precocious Puberty, Sexual Precocity
- Being tested
- Triptorelin acetate and Gonadorelin acetate, Gonadorelin acetate and Triptorelin acetate
- Keywords
- Triptorelin acetate, precocious puberty, premature thelarche, GnRH analog, Diagnostic validation study
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin acetate and Gonadorelin acetateDiagnostic test
Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.
Gonadorelin acetate and Triptorelin acetateDiagnostic test
Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.
| Study group | Role | What they receive |
|---|---|---|
| Triptorelin test AND LHRH test | Active comparator | Patients undergo two tests with a test interval of at least 15 days Receives: 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. Receives: Diagnostic Test: Gonadorelin acetate and Triptorelin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
LH
Levels of LH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Measured: 3 hs
Estradiol
Levels of Estradiol are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Measured: 24 hs
Secondary outcomes (1)
FSH
Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation.
Measured: 3 hs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Precocious PubertyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Analía Freire, Hospital de Niños R. Gutierrez de Buenos Aires
- Investigators
- Maria G Ropelato, PhD, Study director, División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, ArgentinaAnalía V Freire, MD, Principal investigator, División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278290
- Sponsor's protocol ID
- HNinosBuenosAires-Triptorelin
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2011
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triptorelin Acetate Utilization for the Early Diagnosis of Central Precocious Puberty (CPP) in Girls.
- ClinicalTrials.gov ID
- NCT01278290
- Acronym / sponsor ID
- HNinosBuenosAires-Triptorelin
- Conditions
- Central Precocious Puberty, Sexual Precocity
- Keywords
- Triptorelin acetate, precocious puberty, premature thelarche, GnRH analog, Diagnostic validation study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospital de Niños R. Gutierrez de Buenos AiresUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triptorelin test AND LHRH test | Active comparator | Diagnostic Test: Triptorelin acetate and Gonadorelin acetatePatients undergo two tests with a test interval of at least 15 days |
| LHRH test AND Triptorelin test | Active comparator | Diagnostic Test: Gonadorelin acetate and Triptorelin acetatePatients undergo two test with a test interval of al least 15 days. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- premature thelarche and/or
- accelerated growth velocity (above 90 percentile)
- advanced bone age at least 1.5 year in relation to chronological age.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triptorelin acetate and Gonadorelin acetateTriptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous. | Diagnostic test | Triptorelin test AND LHRH test |
| Gonadorelin acetate and Triptorelin acetateGonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2. | Diagnostic test | LHRH test AND Triptorelin test |
Primary outcome
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.
1 secondary outcome
FSH
Time frame: 3 hs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria G Ropelato, PhD study director
División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina
Analía V Freire, MD principal investigator
División de Endocrinología, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptorelin acetate and Gonadorelin acetate and Gonadorelin acetate and Triptorelin acetate in people with Central Precocious Puberty and Sexual Precocity, run by Hospital de Niños R. Gutierrez de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LH (time frame: 3 hs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.