Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma

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-center, open-label, single-arm study conducted in 2 parts.

Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety.

If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II).

Who Took Part

Enrollment: 137 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 22 inclusion and 19 exclusion criteria; among the exclusions: receipt of any vaccination (including influenza) within 4 weeks of baseline; history of blood donation within 2 months of baseline; history of anaphylaxis to any lh-rh analogues.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Leuprolide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2014-08 with completion listed for 2016-08-30.

It ran at 29 sites in United States (8), Taiwan (6), Poland (4), Czechia (3), Lithuania (3) and Austria (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Number of Participants With Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Leuprolide in 137 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.