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Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate
Plain-language guide to NCT02974270: phase 4 interventional trial of Leuprolide, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02974270
- Phase
- phase 4
- Status
- status unknown
- Start
- 2016-06
- Completion (planned or actual)
- 2018-03
- Participants
- 100 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Precocious Puberty, Central
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Leuprolide.
Analysis of body mass index in Central Precocious Puberty patients treated with leuprolide acetate.
It had 1 arm (groups): Leuprolide acetate (experimental).
The registry classes the interventions as drug.
Who Took Part
100 planned participants were the target.
It was open to people of any sex aged up to 9 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Chronological age(CA) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys. Tanner stage ≥2. Advanced bone age (Bone Age/Chronological Age \>1.1). Able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion; patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition; currently on or planning growth hormone treatment.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2016-06 with completion listed for 2018-03.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 6 months (time frame: 6 months).
It also tracked 1 secondary outcome, for example Change from baseline Body Mass Index Standard Deviation Score for Chronological Age at 3 months.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Leuprolide in 100 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
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.