Explorative Study of Degarelix for Treatment of Benign Prostatic Hyperplasia.

What Was Tested

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

This exploratory study will be conducted open label in a single investigational clinical unit.

Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix.

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

The registry classes the interventions as drug.

More on the Plan

The present study aims at exploring the potential of the currently available formulation of degarelix to treat BPH with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/mL.

Who Took Part

52 actual participants took part.

It was open to men only aged from 55 years up to 75 years.

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

Examples of who could join: Man, 55 to 75 years of age. Has a baseline testosterone level above 3 ng/mL at screening.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: previous surgery of the prostate; previous treatment with gnrh agonists or gnrh antagonists.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Degarelix and who got the comparison, which limits bias.

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

Being open-label, the Degarelix study did not mask who received what.

It started in 2007-10 with completion listed for 2009-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Testosterone Area Below Baseline Interval (time frame: 0-42 Days). Time of Testosterone Concentration Below Baseline Interval (time frame: Day 0-42). Minimal Value of Testosterone (Cnadir) (time frame: Day 0-42).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 52 people with hyperparathyroidism.

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

More context: the Degarelix compound page, Hyperparathyroidism research.