Extension Study Investigating the Long-Term Safety and Tolerability of Repeat Doses of FE200486 in Prostate Cancer Patients

What Was Tested

The trial (phase 2) is built around Degarelix.

It had eight arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (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 CS07; NCT00818623) and the extension study FE200486 CS07A.

Who Took Part

Enrollment: 131 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 or over. Histologically proven adenocarcinoma of the prostate (all stages) in whom endocrine treatment was indicated (except neoadjuvant hormonal therapy). Has completed Study FE200486 CS07. Has not met a withdrawal criteria at Visit 9 (day 28) in Study FE200486 CS07.

The full record lists 4 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.

Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.

It started in 2003-03 with completion listed for 2006-03.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Liver Function Tests (time frame: 3 years). Participants With Markedly Abnormal Change in Vital Signs and Body Weight (time frame: 3 years).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 131 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.