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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

NCTNCT01215513 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS42A
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
127 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

South Korea

Start
Sept 2010
Primary completion
Apr 2012
Completion
Apr 2012
First posted
6 Oct 2010 (estimated)
Last update posted
22 May 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
2010201120122013
  1. Ph 3

    Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Korean Patients

    NCT01215513

    Sept 2010 to Apr 2012

Registry summary

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

This is an open-label, multi-centre single arm trial to investigate long-term safety and tolerability of degarelix in Korean patients with prostate cancer.

Interventions

  • DegarelixDrug

Arms1

  • Experimental

    Degarelix

Primary outcomes3

Outcomes the sponsor listed as primary.

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

    Time frame · From baseline (day 0) to end of treatment (up to day 364)

    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 participant with abnormal value are presented, more variables were included in the study. ULN=upper limit of normal

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

    Time frame · From baseline (day 0) to end of treatment (up to day 364)

    Registry description

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

  3. Number of Participants With Markedly Abnormal Values in ECG Variables

    Time frame · From baseline (day 0) to end of treatment (up to day 364)

    Registry description

    This outcome measure included incidence of markedly abnormal changes in ECG variables (PR, QRS, and QT interval, QTcF, and ventricular rate). The figures present the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Secondary outcomes(1)

  1. Serum Levels of Prostate Specific Antigen (PSA) Over Time

    Time frame · Day 0, day 196, day 280, and day 364

    Registry description

    PSA levels were measured over time. The figures present the median level at day 0 (n=155 participants), day 196 (n=148), day 280 (n=115), and day 364 (n=109).

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· From baseline (day 0) to end of treatment (up to day 364)

Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables

GroupValue (Participants)
Degarelix1
Primary outcomeNumber· From baseline (day 0) to end of treatment (up to day 364)

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

GroupValue (Participants)
Degarelix13
Primary outcomeNumber· From baseline (day 0) to end of treatment (up to day 364)

Number of Participants With Markedly Abnormal Values in ECG Variables

GroupValue (Participants)
Degarelix1
Secondary and other outcome results(1)
Secondary outcomeMedian· Day 0, day 196, day 280, and day 364

Serum Levels of Prostate Specific Antigen (PSA) Over Time

GroupValue (ng/mL)
Degarelix19.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Degarelix80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.–25 / 15688 / 156

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 informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient * Has completed the 7-month main trial, FE200486 CS42 Exclusion Criteria: * Has been withdrawn/discontinued from the FE200486 CS42 trial * A patient may also not be entered into the CS42A trial at the discretion of the investigator due to safety or lack of efficacy concerns (LH or PSA response) in the CS42 trial.

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