← Human Trials & Peer-Reviewed Studies
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS [amount hidden]) in Subjects With Prostate Cancer
Plain-language guide to NCT03261999: phase 3 interventional trial of Leuprolide, 144 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03261999
- Phase
- phase 3
- Status
- completed
- Start
- 2017-09-26
- Completion (planned or actual)
- 2018-11-19
- Participants
- 144 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostatic Neoplasms
- 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): one (experimental).
The registry classes the interventions as drug.
More on the Plan
This is a multi-national, multi-center, open-label, single-arm study.
Who Took Part
Enrollment: 144 actual participants took part.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Males aged ≥ 18 years old. Males with histologically confirmed carcinoma of the prostate. Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy. Baseline morning serum testosterone level \> 150 ng/dL performed at Screening Visit. Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2.
The full record lists 23 inclusion and 19 exclusion criteria; among the exclusions: receipt of any vaccination (including influenza) within 4 weeks of screening visit; history of blood donation within 2 months of screening visit; history of anaphylaxis to any lh-rh analogues.
How the Study Was Run
It was run as a single-group and open-label study.
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 2017-09-26 with completion listed for 2018-11-19.
It ran at 21 sites in United States (6), South Korea (6), Lithuania (4), Czechia (3) and Slovakia (2).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example Number of Participants With Adverse Events.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Leuprolide in 144 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.