Study Investigating the Long-Term Safety and Tolerability of Repeated Doses of Degarelix in Prostate Cancer Patients

What Was Tested

In this phase 2 trial, researchers set out to test Degarelix.

It had three arms (groups): Degarelix 80/80 + 40 (experimental), Degarelix 40/40 + 40 (experimental) and Degarelix 80 + 20 (experimental).

The registry classes the interventions as drug.

More on the Plan

Degarelix was not FDA regulated at the time of the trial.

After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention (FDA regulated intervention is therefore ticked "YES").

The data include participants from both the main study (FE200486 CS02; NCT00819247) and the extension study FE200486 CS02A.

Who Took Part

88 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: Has completed study treatment in study FE200486 CS02. Has completed visit 16 in study FE200486 CS02. Has not met any withdrawal criteria up to and including visit 15 in FE200486 CS02.

The full record lists 3 inclusion and 0 exclusion criteria.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Degarelix was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2001-10 with completion listed for 2006-03.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Liver Function Tests (time frame: 3 years). Participants With Markedly Abnormal Change in Vital Signs and Body Weight (time frame: 3 years).

It also tracked 1 secondary outcome, for example Serum Levels of Testosterone After 1, 2, and 3 Years.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 88 people.

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

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