Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension [amount hidden] in the Treatment of Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

The registry classes the interventions as drug.

Who Took Part

The registry lists 201 actual participants took part.

It was open to men only aged from 45 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Reads, understands and is able and willing to sign informed consent form. Males greater than or equal to age 45. Histologically and cytologically documented prostate carcinoma. Candidate for initial hormone therapy - inclusive of patients beginning neoadjuvant or intermittent therapy, being treated locally for advanced disease, or patients beginning therapy for failure of prior local therapy. Morning serum testosterone level \> 150 ng/dL.

The full record lists 11 inclusion and 20 exclusion criteria; among the exclusions: patients who have undergone any prostatic surgery within 4 weeks of baseline; patients who have undergone orchiectomy, adrenalectomy, or hypophysectomy; patients that are currently hospitalized or require frequent hospitalization.

How the Study Was Run

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

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

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 2007-04 with completion listed for 2008-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The percentage of responders who attain and maintain castrate levels of serum testosterone (time frame: From Day 28 to Day 168).

It also tracked 3 secondary outcomes, for example Leuprolide serum profiles following administration study drug product.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 201 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.