Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin test AND LHRH test | Active Comparator | Patients undergo two tests with a test interval of at least 15 days |
|
| LHRH test AND Triptorelin test | Active Comparator | Patients undergo two test with a test interval of al least 15 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin acetate and Gonadorelin acetate | Diagnostic Test | Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| FSH | Levels of FSH are measured at T 0 (before) and T 3 h y T 24 h (after) Triptorelin stimulation. | 3 hs |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Niños Ricardo Gutierrez, División de Endocrinología | Buenos Aires | C1425SEFD | Argentina |
Not provided
| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gonadorelin acetate and Triptorelin acetate | Diagnostic Test | Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2. |
|