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Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

NCTNCT00117286 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS14A
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
57 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Not randomized · Open label (no masking)
Countries
2 countries

United States, Canada

Start
Mar 2005
Primary completion
Sept 2009
Completion
Nov 2009
First posted
6 Jul 2005 (estimated)
Last update posted
18 Dec 2025
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520062007200820092010
  1. Ph 2/3

    Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

    NCT00117286

    Mar 2005 to Nov 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This was an extension study for the study FE200486 CS14 (NCT00116779). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained. The study was terminated when all ongoing participants had been treated for at least 5 years.

Interventions

  • DegarelixDrug

Arms2

  • Experimental

    Degarelix (60 mg to 160 mg)

    Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.

  • Experimental

    Degarelix (80 mg to 160 mg)

    Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Participants With Markedly Abnormal Change in Vital Signs and Body Weight

    Time frame · 5 years

    Registry description

    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.

  2. Liver Function Tests

    Time frame · 5 years

    Registry description

    The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases \>3x ULN and ALT increases \>3x ULN with concurrently increased bilirubin \>1.5 ULN.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 5 years

Participants With Markedly Abnormal Change in Vital Signs and Body Weight

GroupValue (participants)
Degarelix (60 mg to 160 mg)9
Degarelix (80 mg to 160 mg)4
Primary outcomeNumber· 5 years

Liver Function Tests

GroupValue (participants)
Degarelix (60 mg to 160 mg)8
Degarelix (80 mg to 160 mg)11

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix (60 mg to 160 mg)Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.–11 / 3029 / 30
Degarelix (80 mg to 160 mg)Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.–7 / 2726 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Has given written consent prior to any study-related activity being performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has completed study FE200486 CS14 through visit 22. Exclusion Criterion: * Has been withdrawn from the FE200486 CS14 study.

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