Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

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

NCTNCT00268892Other idFE200486 CS15A

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 278 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Not randomized · Open label (no masking)
Countries: 10 countries
Belgium, Finland, France, Germany, Montenegro, Netherlands, Romania, Russia, Serbia, United Kingdom
Start: Jan 2006
Primary completion: Sept 2009
Completion: Dec 2009
First posted: 23 Dec 2005 (estimated)
Last update posted: 24 Dec 2010 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20062007200820092010

Ph 2/3
Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
NCT00268892
Jan 2006 to Dec 2009

Registry summary

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

The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.

Interventions

DegarelixDrug
DegarelixDrug
DegarelixDrug

Arms3

Experimental
Degarelix 240/240@40(1-3-6-9)
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Experimental
Degarelix 240/240@60(1-3-6-9)
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Experimental
Degarelix 240/240@60(1-4-7-10)
Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Primary outcomes2

Outcomes the sponsor listed as primary.

Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
Time frame · Baseline and up to 4.5 years
Registry description
This outcome measure included incidence of markedly abnormal values in blood pressure (systolic and diastolic), pulse, and body weight during the trial. The table presents the number of participants with a normal baseline value and at least one post-baseline markedly abnormal value.
Liver Function Tests
Time frame · 4.5 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· Baseline and up to 4.5 years

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

Group	Value (participants)
Degarelix 240/240@40(1-3-6-9)	5
Degarelix 240/240@60(1-3-6-9)	6
Degarelix 240/240@60(1-4-7-10)	4

Primary outcomeNumber· 4.5 years

Liver Function Tests

Group	Value (participants)
Degarelix 240/240@40(1-3-6-9)	22
Degarelix 240/240@60(1-3-6-9)	22
Degarelix 240/240@60(1-4-7-10)	17

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Degarelix 240/240@40(1-3-6-9)Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	–	30 / 90	72 / 90
Degarelix 240/240@60(1-3-6-9)Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	–	24 / 95	75 / 95
Degarelix 240/240@60(1-4-7-10)Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).	–	21 / 93	69 / 93

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 is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. * Has successfully completed the main study. Exclusion Criterion: \- Has been withdrawn from the main study.

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