← Human Trials & Peer-Reviewed Studies

Effect of Degarelix, a Gonadotropin-Releasing Hormone Receptor Antagonist for the Treatment of Prostate Cancer, on Cardiac Repolarisation in a Randomised, Placebo and Active Comparator Controlled Thorough QT/QTc Trial in Healthy Men

Plain-language guide to PMID 28660498 (2017): double-blind randomized controlled trial study of Degarelix.

Key Facts

PMID
28660498
Journal
Clinical drug investigation
Year
2017
Study type
Randomized Controlled Trial
Authors
Olsson H et al. (5 authors)
DOI
10.1007/s40261-017-0547-7

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of Degarelix, published as a randomized controlled trial.

Degarelix is a gonadotropin-releasing hormone antagonist registered for the treatment of advanced hormone-dependent prostate cancer.

Who Took Part

PubMed indexes the participants as teenagers, young adults, adults and middle-aged adults, men only.

Degarelix and placebo treatments were double-blind, whereas moxifloxacin treatment was open-label.

How the Study Was Run

The design is described as randomized, double-blind, open-label, placebo-controlled and crossover.

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

Blinding on both sides kept the participants and researchers unaware of who received Degarelix.

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

Some participants received a placebo instead of Degarelix, giving a reference point.

This was a single-centre, randomised, crossover study comparing the effect of degarelix, placebo, and the positive control moxifloxacin on the QT interval.

Electrocardiograms were collected up to 24 h after the start of administration, with the QT interval assessed and plasma concentrations of degarelix concomitantly analysed.

What Was Measured

The subject headings attached to it are Electrocardiography, Fluoroquinolones, Long QT Syndrome, Moxifloxacin, Oligopeptides and Receptors, LHRH.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Degarelix.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2017 (Clinical drug investigation), a journal based in New Zealand.

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

Our Notes on the Compound

Degarelix: A GnRH antagonist injection (Firmagon) for advanced prostate cancer that lowers testosterone within days without the initial surge seen with agonists.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.