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Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
Plain-language guide to NCT00909844: phase 3 interventional trial of Triptorelin, 35 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00909844
- Phase
- phase 3
- Status
- completed
- Start
- 2008-04
- Completion (planned or actual)
- 2015-04
- Participants
- 35 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Precocious Puberty
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Triptorelin.
It had 1 arm (groups): Triptorelin (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 35 actual participants took part.
It was open to people of any sex.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: The child must have completed study 2-54-52014-143.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: the patient has a known hypersensitivity to any of the test materials or related compounds; the patient is unable or unwilling to comply fully with the protocol.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2008-04 with completion listed for 2015-04.
It ran at 10 sites in France (10).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Percentage of Children With a Stabilisation or Regression of Tanner Pubertal Stage at the End of the Study (Final Visit), Compared to Pretreatment (Month -6) and Baseline (Month 0) (time frame: Months 12, 24, 36, 48 and Final Visit (if applicable; up to 63 months)).
It also tracked 12 secondary outcomes, for example Percentage of Patients With a Suppressed Luteinizing Hormone (LH) Response to Gonadotropin-Releasing Hormone (GnRH) Test, Levels of Oestradiol in Girls or Testosterone in Boys Both Measured by Radioimmunoassay (RIA), Percentage of Patients With a Suppressed Follicle Stimulating Hormone (FSH) Response to GnRH Test, Body Mass Index (BMI) for Chronological Age Variation, BMI Standard Deviation (SD) Score for Chronological Age Variation and Auxological Parameters Variations: Height SD Score.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Triptorelin in 35 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Triptorelin compound page, all human trials.
Our Notes on the Compound
Triptorelin: A 10-amino-acid GnRH analog (Trelstar, Decapeptyl, Triptodur) used in prostate cancer, early puberty and fertility protocols.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.