A Trial of Degarelix in Men With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)

What Was Tested

This registered phase 2 trial tested Degarelix for hyperparathyroidism.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 404 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: Signed informed consent obtained before any trial-related activity is performed. Men, aged 50 or older. Clinical signs and symptoms of BPH for ≥6 months. Moderate to severe LUTS at screening, as defined by International Prostate Symptom Score (IPSS) ≥13. An IPSS QoL score of ≥3 at screening.

The full record lists 7 inclusion and 32 exclusion criteria; among the exclusions: stone in the bladder or urethra causing symptoms; acute or chronic prostatitis; interstitial cystitis / painful bladder syndrome.

How the Study Was Run

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

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

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

Neither the hyperparathyroidism participants nor the staff measuring them knew who was on Degarelix, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2009-08 with completion listed for 2011-03.

It ran at 47 sites in United States (15), Canada (15), Czechia (9), Italy (3), Poland (3) and Belgium (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Change in International Prostate Symptom Score (IPSS).

It also tracked 4 secondary outcomes, for example Mean Change in IPSS, Mean Percentage Change in Total Prostate Volume (TPV) and Mean Change in Maximum Urinary Flow (Qmax).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 404 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.