Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486

What Was Tested

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

In addition, safety and tolerance data were generated.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 82 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: Is at least 18 years. Has an ECOG score of 2. Has a baseline testosterone level within the age specific normal range as measured by the central laboratory. Has a PSA value of 2 ng/mL as measured by the central laboratory. Has a life expectancy of at least 6 months.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: requires hormonal therapy for neoadjuvant purposes; is recently (within the last 12 weeks preceding visit 1) or presently treated with any other drug modifying the testosterone level or function; is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months after visit 1.

How the Study Was Run

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

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

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

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 2002-04 with completion listed for 2004-01.

It ran at 12 sites in United States (12).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time to Meet Insufficient Testosterone Response (time frame: 3 months). Number of Participants With Testostestone Serum Levels Below 0.5 ng/mL for at Least 28 Days (time frame: 28 days).

It also tracked 5 secondary outcomes, for example Time to Testosterone Castration (Testosterone ≤0.5 ng/mL), Number of Participants With Sufficient Testosterone Suppression for at Least 84 Days and Liver Function Tests.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 82 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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