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.

Olsson H, Petri N, Erichsen L, Malmberg A, Grundemar L

Clinical drug investigation1 Sept 2017Cited by 14 (Europe PMC)

PMID28660498PMCIDPMC5569649DOI10.1007/s40261-017-0547-7PepBankPUB-28660498

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialSafety outcome
In healthy men, upper confidence boundaries for placebo-corrected QTcF changes with degarelix did not exceed 10 ms at any timepoint.
In plain wordsIn healthy men, upper confidence boundaries for QTcF changes with degarelix versus placebo did not exceed 10 ms.
Peptide
Degarelix
Outcome
No significant changeQTcF
Study
n = 80
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
2.8 mg single dose · intravenousAs given in this study (human).
Measurements
Upper 95% confidence boundary of placebo-corrected ΔΔQTcF
≤ 10 ms
degarelix 2.8 mg, any timepoint
Source sentences
Summary
Time-matched, one-sided 95% upper confidence boundaries for baseline-corrected average changes from placebo for the QT interval, corrected using the Fridericia method (ΔΔQTcF), did not exceed 10 ms at any timepoint,
2 context sentences(design, population, supporting numbers)
Summary · context
This was a single-centre, randomised, crossover study comparing the effect of degarelix, placebo, and the positive control moxifloxacin on the QT interval.
Summary · context
Eighty healthy men, aged 18-45 years, received single intravenous doses of degarelix 2.8 mg, and placebo, as well as a single oral dose of moxifloxacin 400 mg.
Report a problemFND-2866049801
02HumanRandomized controlled trialSafety outcome
In healthy men, degarelix had no significant effect on other cardiac parameters.
In plain wordsIn healthy men, degarelix had no significant effect on other cardiac parameters compared with placebo.
Peptide
Degarelix
Outcome
No significant changeOther cardiac parameters
Study
n = 80
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
2.8 mg single dose · intravenousAs given in this study (human).
Source sentences
Summary
No significant effect on any other cardiac parameter was observed.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a single-centre, randomised, crossover study comparing the effect of degarelix, placebo, and the positive control moxifloxacin on the QT interval.
Summary · context
Eighty healthy men, aged 18-45 years, received single intravenous doses of degarelix 2.8 mg, and placebo, as well as a single oral dose of moxifloxacin 400 mg.
Report a problemFND-2866049804
03HumanNon-randomized trialPharmacokinetics
In healthy men, maximum degarelix concentrations reached approximately threefold those seen during prostate cancer treatment.
In plain wordsIn healthy men, maximum degarelix concentrations reached approximately threefold those seen during prostate cancer treatment.
Peptide
Degarelix
Outcome
IncreaseMaximum degarelix concentrations
Study
n = 80
Comparator
Concentrations during prostate cancer treatment
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
2.8 mg single dose · intravenousAs given in this study (human).
Measurements
Maximum degarelix concentration relative to concentrations in prostate cancer treatment
≈ 3 fold
healthy men, degarelix 2.8 mg intravenous
Source sentences
Summary
with maximum degarelix concentrations reaching approximately threefold the concentrations seen in the treatment of prostate cancer.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a single-centre, randomised, crossover study comparing the effect of degarelix, placebo, and the positive control moxifloxacin on the QT interval.
Summary · context
Eighty healthy men, aged 18-45 years, received single intravenous doses of degarelix 2.8 mg, and placebo, as well as a single oral dose of moxifloxacin 400 mg.
Report a problemFND-2866049802
04HumanObservational studySafety outcome
In healthy men, concentration-exposure analysis indicated no QT prolongation effect of degarelix.
In plain wordsIn healthy men, concentration-exposure analysis indicated no QT prolongation effect of degarelix.
Peptide
Degarelix
Outcome
No significant changeConcentration-related QT prolongation
Study
n = 80
Outcome group
Heart function · Cardiovascular
Studied dose
2.8 mg single dose · intravenousAs given in this study (human).
Source sentences
Summary
Furthermore, concentration-exposure analysis indicated absence of any QT prolongation effects of degarelix.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a single-centre, randomised, crossover study comparing the effect of degarelix, placebo, and the positive control moxifloxacin on the QT interval.
Summary · context
Eighty healthy men, aged 18-45 years, received single intravenous doses of degarelix 2.8 mg, and placebo, as well as a single oral dose of moxifloxacin 400 mg.
Report a problemFND-2866049803

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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