Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer

NCTNCT00215683Other idFE200486 CS12A

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 137 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Not randomized · Open label (no masking)
Countries: 7 countries
Belgium, Germany, Hungary, Netherlands, Romania, Russia, South Africa
Start: Feb 2005
Primary completion: Oct 2009
Completion: Nov 2009
First posted: 22 Sept 2005 (estimated)
Last update posted: 1 Apr 2015 (estimated)
Conditions: Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

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

200520062007200820092010

Ph 2/3
An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
NCT00215683
Feb 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 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.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 (including one year in the main study).

Interventions

DegarelixDrug

Arms3

Experimental
Degarelix 80 mg
Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Experimental
Degarelix 120 mg
Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Experimental
Degarelix 160 mg
Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).

Primary outcomes2

Outcomes the sponsor listed as primary.

Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Time frame · 5 years
Registry description
Vital signs and body weight 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.
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

Group	Value (participants)
Degarelix 80 mg	3
Degarelix 120 mg	5
Degarelix 160 mg	10

Primary outcomeNumber· 5 years

Liver Function Tests

Group	Value (participants)
Degarelix 80 mg	19
Degarelix 120 mg	18
Degarelix 160 mg	23

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Degarelix 80 mgParticipants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	–	19 / 45	35 / 45
Degarelix 120 mgParticipants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	–	20 / 48	41 / 48
Degarelix 160 mgParticipants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.	–	10 / 44	38 / 44

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: * Had given written consent before any study-related activity was performed (a study-related activity was defined as any procedure that would not have been performed during the normal management of the participant) * Had completed the FE200486 CS12 study Exclusion criterion: * Had been withdrawn from the FE200486 CS12 study

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