Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

What Was Tested

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

Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men.

It had three arms (groups): one (experimental), one (experimental) and Treatment Group C: Placebo (placebo comparator).

Treatment course 1: * Week 0: placebo (2 injections) * Week 2: placebo (1 injection) Treatment course 2: * Week 26: placebo (2 injections) * Week 28: placebo (1 injection) 4 days with treatment, Day 1 of each indicated week, 6 injections in total per patient.

The registry classes the interventions as drug.

More on the Plan

Patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).

Patients will then be allocated to study drug in a double-blind, randomized, double-dummy, placebo-controlled fashion.

Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will be followed up to Week 52.

Then, in an open label fashion, patients will be administered an IM injection of study drug at Week 52, 54, 78 and 80 and will be followed up to Week 90.

Who Took Part

The registry lists 667 actual participants took part.

It was open to men only aged from 50 years with no upper age limit.

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

Examples of who could join: Benign Prostatic Hyperplasia, based on medical history.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: urgent need for prostate surgery or prior surgical treatment of the prostate or bladder; major organ dysfunction; eczema (atopic dermatitis) treated during the last 6 months.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cetrorelix group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cetrorelix.

Those kept unaware of assignments: participant and investigator.

It started in 2007-03 with completion listed for 2009-06.

It ran at 68 sites in United States (46), Canada (14), Germany (7) and Bulgaria (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: International Prostate Symptoms Score (IPSS) (time frame: Baseline and 52 weeks).

It also tracked 1 secondary outcome, for example Time Course of Quality of Life.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cetrorelix in 667 people.

With 667 participants it is a large trial for this field.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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