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A Study to Evaluate Leuprolide Acetate [amount hidden] 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Plain-language guide to NCT03695237: phase 3 interventional trial of Leuprolide, 45 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03695237
- Phase
- phase 3
- Status
- completed
- Start
- 2018-10-24
- Completion (planned or actual)
- 2021-05-06
- Participants
- 45 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Central Precocious Puberty (CPP)
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Leuprolide.
It had 1 arm (groups): Leuprolide Acetate (LA) (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 45 actual participants took part.
It was open to people of any sex aged from 2 years up to 11 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 2 inclusion and 0 exclusion criteria.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Leuprolide 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 2018-10-24 with completion listed for 2021-05-06.
It ran at 18 sites in United States (17) and Puerto Rico (1).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24.
It also tracked 9 secondary outcomes, for example Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48, Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48, Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48, Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty, Parts 1 and 2: Change From Baseline in Incremental Growth Rate and Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Leuprolide in 45 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.