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CompletedNCT00268892Updated Dec 24, 2010Results posted

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

A Phase 2/3 interventional study of Degarelix and Degarelix in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Completed at 23 sites in 10 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-12-24.

Sponsored by Ferring Pharmaceuticals · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
278
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the detailed description

The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Prostate Cancer
  • Androgen ablation therapy
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's enrollment of 278 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 249 studies on the registry; 4 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 14 (93%) have results posted.

Browse Ferring Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 criteria

Exclusion Criterion:

  • Has been withdrawn from the main study.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
278 participants (actual)

Study arms

  • 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).

    Drug: Degarelix

  • 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).

    Drug: Degarelix

  • 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).

    Drug: Degarelix

Interventions

  • DrugDegarelix

    Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.

    Also known as: FE200486

  • DrugDegarelix

    Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.

    Also known as: FE200486

  • DrugDegarelix

    Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL). Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.

    Also known as: FE200486

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Baseline and up to 4.5 years

  2. Liver Function Tests

    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.

    Time frame: 4.5 years

07

Results

Posted Dec 6, 2010

Participant flow

Participants who completed the main FE200486 CS15(NCT00113753) study (except those in US and Canada) were asked to continue into the FE200486 CS15A extension study.

Participant flow — Overall Study
MilestoneDegarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)
Started909593
Switched to higher dose596876
Completed515354
Not completed394239
Withdrew: Adverse event141720
Withdrew: Lack of efficacy130
Withdrew: Withdrawal by subject141513
Withdrew: Physician decision010
Withdrew: Lost to follow-up524
Withdrew: Protocol violation010
Withdrew: Disease progression110
Withdrew: Trial site closed422

Outcome measures

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

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.

Time frame:
Baseline and up to 4.5 years
Reported as:
Number · participants
Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight
participantsDegarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)
Diastolic blood pressure <=50 and decrease >=15564
Diastolic blood pressure >=105 and increase >=15768
Systolic blood pressure <=90 and decrease >=20112
Systolic blood pressure >=180 and increase >=2081110
Heart rate <=50 and decrease >=159105
Heart rate >=120 and increase >=15141
Body weight decrease of >=7 percent784
Body weight increase of >=7 percent323541
PrimaryLiver Function Tests

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.

Time frame:
4.5 years
Reported as:
Number · participants
Liver Function Tests
participantsDegarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)
Abnormal alanine aminotransferase (ALAT)222217
Abnormal aspartate aminotransferase182519
Abnormal bilirubin453
ALAT >3x upper limit of normal (ULN)323
ALAT >3x ULN, bilirubin >1.5x ULN000

Adverse events

Collected over 4.5 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Degarelix 240/240@40(1-3-6-9)—30/90 (33.3%)72/90 (80%)
Degarelix 240/240@60(1-3-6-9)—24/95 (25.3%)75/95 (78.9%)
Degarelix 240/240@60(1-4-7-10)—21/93 (22.6%)69/93 (74.2%)
Most frequent serious events
Showing 10 of 110
Most frequent serious events
EventDegarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)
Urinary retentionRenal and urinary disorders7/903/950/93
Hip fractureInjury, poisoning and procedural complications3/901/950/93
Acute myocardial infarctionCardiac disorders2/900/950/93
Prostate cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/901/951/93
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/900/952/93
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders0/900/952/93
HaematuriaRenal and urinary disorders0/902/951/93
HydronephrosisRenal and urinary disorders0/902/951/93
Myocardial ischaemiaCardiac disorders1/901/951/93
Atrial fibrillationCardiac disorders1/901/950/93
Most frequent other events
Showing 10 of 36
Most frequent other events
EventDegarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)
Hot FlushVascular disorders31/9027/9532/93
Injection Site PainGeneral disorders24/9024/9516/93
Injection Site ErythemaGeneral disorders15/9014/956/93
PyrexiaGeneral disorders12/909/957/93
Weight IncreasedInvestigations11/909/957/93
FatigueGeneral disorders10/909/958/93
ArthralgiaMusculoskeletal and connective tissue disorders10/907/956/93
NauseaGastrointestinal disorders5/9010/952/93
Injection Site SwellingGeneral disorders5/9010/953/93
Back PainMusculoskeletal and connective tissue disorders9/905/956/93

Baseline characteristics

Age Continuous
Age Continuous(years)Degarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)Total
Mean72.7 ± 6.5573.3 ± 7.0071.8 ± 7.0572.6 ± 6.88
Sex: Female, Male
Sex: Female, Male(Participants)Degarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)Total
Female0000
Male909593278
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Degarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)Total
American Indian or Alaska Native0011
Asian0112
Native Hawaiian or Other Pacific Islander0000
Black or African American35311
White878988264
More than one race0000
Unknown or Not Reported0000
Body Weight
Body Weight(kilogram)Degarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)Total
Mean76.7 ± 13.076.9 ± 12.276.5 ± 12.876.7 ± 12.6
Body Mass Index
Body Mass Index(kilogram per square meter)Degarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)Total
Mean25.4 ± 4.1425.8 ± 3.9325.8 ± 4.1625.7 ± 4.07
Curative Intent
Curative Intent(participants)Degarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)Total
Yes1012729
No808386249
Gleason Score
Gleason Score(participants)Degarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)Total
2-41361332
5-633303497
7-10445846148
Stage of Prostate Cancer
Stage of Prostate Cancer(participants)Degarelix 240/240@40(1-3-6-9)Degarelix 240/240@60(1-3-6-9)Degarelix 240/240@60(1-4-7-10)Total
Localized343736107
Locally Advanced26262880
Metastatic16192055
Not Classifiable1413936

1 further baseline measures are reported on the registry.

08

Study locations

23 sites
  • UZ Gasthuisberg Leuven
    Leuven, Belgium
  • Helsinki University Hospital, Maria Hospital, Building 11
    Helsinki, Finland
  • Central Hospital, North Karelian
    Joensuu, Finland
  • Oulu University Hospital
    Oulu, Finland
  • Tampere University Hospital
    Tampere, Finland
  • Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur
    Nice, France
  • Gemeinschaftspraxis Dres Effert und Benedic
    Aachen, Germany
  • Clinical Center Novi Sad, Clinic of Urology
    Novi Sad, Montenegro
  • Academic Medical Center, Urology
    Amsterdam, Netherlands
  • St. Elisabeth Hospital
    Tilburg, Netherlands
  • "Centrul Medical Privat" Prof. Dr. Ioiart Ioan"
    Arad, Romania
  • Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department
    Bucharest, Romania
  • University CF Hospital No. 2
    Bucharest, Romania
  • Andros Clinic
    St. Petersburg, Russian Federation
  • City Hospital #15
    St. Petersburg, Russian Federation
  • City Hospital #26
    St. Petersburg, Russian Federation
  • Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department
    St. Petersburg, Russian Federation
  • Pavlov State Medical University, Urology Department
    St. Petersburg, Russian Federation
  • Clinical Center of Serbia, Institute of Urology and Nephrology
    Belgrade, Serbia
  • Mount Vernon Cancer Centre, Marie Cuire Research Wing
    Northwood, Middlesex, United Kingdom
  • Castle Hill Hospital
    Hull, North Humberside, United Kingdom
  • Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans
    Falkirk, United Kingdom
  • Level 7, Urology Research Unit, Derriford Hospital
    Plymouth, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00268892
Lead sponsor
Ferring Pharmaceuticals
First posted
Dec 23, 2005
Start date
Jan 2006
Primary completion
Sep 2009
Completion
Dec 2009
Results posted
Dec 6, 2010
Last update
Dec 24, 2010

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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