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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

NCTNCT00967018 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS34Other idEudraCT No: 2008-006827-29
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
77 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
7 countries

Belgium, France, Italy, Portugal, Spain, Sweden, Turkey (Türkiye)

Start
Aug 2009
Primary completion
Nov 2011
Completion
Dec 2011
First posted
27 Aug 2009 (estimated)
Last update posted
3 Jan 2013 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. Ph 3

    A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

    NCT00967018

    Aug 2009 to Dec 2011

Registry summary

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

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

Interventions

  • DegarelixDrug

Arms1

  • Experimental

    Degarelix

    The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

    Time frame · Up to 22.5 months

    Registry description

    The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.

  2. Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

    Time frame · Up to 22.5 months

    Registry description

    This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

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· Up to 22.5 months

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

GroupValue (Participants)
Degarelix24
Primary outcomeNumber· Up to 22.5 months

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight

GroupValue (Participants)
Degarelix1
Secondary and other outcome results(2)
Other pre specified outcomeMedian· from baseline to 72 weeks

Serum Levels of Prostate Specific Antigen (PSA)Over Time

GroupValue (ng/mL)
Degarelix1.4
Other pre specified outcomeMedian· from baseline to week 72

Serum Levels of Testosterone Over Time

GroupValue (ng/mL)
Degarelix0.05

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
DegarelixThe degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.–5 / 7730 / 77

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: * Completed any of the trials; FE 200486 CS27, CS28, CS30 or CS31 Exclusion Criteria: * Discontinued any of the trials: FE 200486 CS27, CS28, CS30 or CS31

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