search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Degarelix
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Androgen ablation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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during the normal management of the participant) Had completed the FE200486 CS12 study Exclusion criterion: Had been withdrawn from the FE200486 CS12 study

Sites / Locations

  • UCL Saint Luc
  • UZ Gent
  • UZ Gasthuisberg, Urology Department
  • Vivantes Klinikum am Urban, Klinik für Urologie
  • Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim
  • Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology
  • Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology
  • Pez Aladar County Hospital, Dept. of Urology
  • Bács-Kiskun County Hospital, Dept. of Urology
  • BAZ County Hospital, Dept of Urology
  • Hospital of Local Government of Szeged, Dept. of Urology
  • MÁV Hospital, Dept. of Urology
  • Academic Medical Center, Dept. of Urology
  • Atrium MC, Dept. of Urology
  • "Prof.Dr.Th.Burghele" Hospital - Bucharest
  • "Sf. Ioan" Emergency Hospital - Urology Department
  • CF2 Hospital - Bucharest, Urology Department
  • Fundeni Clinical Institute - Bucharest, Urology Department
  • Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department
  • Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)
  • Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)
  • Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1
  • City Hospital #15, Urology Department
  • City Hospital #26, Urology Department
  • I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department
  • Research Institute of Urology of the Ministry of Healthcare of the Russian Federation
  • St. Petersburg Pavlov Medical School, Urology Department
  • St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center
  • "Andros" Urology Clinic, 36A, Lenina St.
  • Glenwood Hospital
  • WITS Medical School, Level 9
  • 401 B Medical Centre
  • Pretoria Urology Hospital, Suite 2, Hatfield
  • Sunninghill Clinic, Suite 3

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Degarelix 80 mg

Degarelix 120 mg

Degarelix 160 mg

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

Participants With Markedly Abnormal Change in Vital Signs and Body Weight
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
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.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2005
Last Updated
March 12, 2015
Sponsor
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00215683
Brief Title
An Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Prostate Cancer
Official Title
An Open-Label, Multi-Centre, Extension Study Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Depots in Patients With Prostate Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL). The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Androgen ablation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
137 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Degarelix 80 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
Degarelix 120 mg
Arm Type
Experimental
Arm Description
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).
Arm Title
Degarelix 160 mg
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Degarelix
Other Intervention Name(s)
Degarelix acetate, FE200486
Intervention Description
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.
Primary Outcome Measure Information:
Title
Participants With Markedly Abnormal Change in Vital Signs and Body Weight
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.
Time Frame
5 years
Title
Liver Function Tests
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.
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
UCL Saint Luc
City
Bruxelles
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
UZ Gasthuisberg, Urology Department
City
Leuven
Country
Belgium
Facility Name
Vivantes Klinikum am Urban, Klinik für Urologie
City
Berlin
Country
Germany
Facility Name
Urologische Universitätsklinikum, Klinikum Mannheim GmbH, Fakultät für Klinische Medizin Mannheim
City
Mannheim
Country
Germany
Facility Name
Bajcsy-Zsilinszky Hospital, of local Government of Budapest, Dept. of Urology
City
Budapest
Country
Hungary
Facility Name
Jahn Ferenc Dél-Pesti Hospital, Dept. of Urology
City
Budapest
Country
Hungary
Facility Name
Pez Aladar County Hospital, Dept. of Urology
City
Györ
Country
Hungary
Facility Name
Bács-Kiskun County Hospital, Dept. of Urology
City
Kecskemét
Country
Hungary
Facility Name
BAZ County Hospital, Dept of Urology
City
Miskolc
Country
Hungary
Facility Name
Hospital of Local Government of Szeged, Dept. of Urology
City
Szeged
Country
Hungary
Facility Name
MÁV Hospital, Dept. of Urology
City
Szolnok
Country
Hungary
Facility Name
Academic Medical Center, Dept. of Urology
City
Amsterdam
Country
Netherlands
Facility Name
Atrium MC, Dept. of Urology
City
Heerlen
Country
Netherlands
Facility Name
"Prof.Dr.Th.Burghele" Hospital - Bucharest
City
Bucharest
Country
Romania
Facility Name
"Sf. Ioan" Emergency Hospital - Urology Department
City
Bucharest
Country
Romania
Facility Name
CF2 Hospital - Bucharest, Urology Department
City
Bucharest
Country
Romania
Facility Name
Fundeni Clinical Institute - Bucharest, Urology Department
City
Bucharest
Country
Romania
Facility Name
Moscow State University of Medicine and Dentistry, Department of Urology, Urogynecology and Andrology, City Hospital #50, Urology Department
City
Moscow
Country
Russian Federation
Facility Name
Russian Medical Academy of Postgraduate Education, Department of Gerontolology and Geriatrics, Moscow City Hospital #60, Urology Department, 84/1, Entuziastov Shosse (Hospital)
City
Moscow
Country
Russian Federation
Facility Name
Russian Medical Academy of Postgraduate Education, Urology Department, Moscow Clinical Hospital n.a. Botkin, Urology Department, 5/16, 2-oy Botkinsky proezd (Hospital)
City
Moscow
Country
Russian Federation
Facility Name
Russian State Medical University, Department of Urology and Surgical Nephrology, Moscow City Hospital #1
City
Moscow
Country
Russian Federation
Facility Name
City Hospital #15, Urology Department
City
St Petersburg
Country
Russian Federation
Facility Name
City Hospital #26, Urology Department
City
St Petersburg
Country
Russian Federation
Facility Name
I.I. Mechnikov St. Petersburg State Medical Academy, Urology Department
City
St Petersburg
Country
Russian Federation
Facility Name
Research Institute of Urology of the Ministry of Healthcare of the Russian Federation
City
St Petersburg
Country
Russian Federation
Facility Name
St. Petersburg Pavlov Medical School, Urology Department
City
St Petersburg
Country
Russian Federation
Facility Name
St.Petersburg Pavlov Medical School, Outpatient Diagnostic Center
City
St Petersburg
Country
Russian Federation
Facility Name
"Andros" Urology Clinic, 36A, Lenina St.
City
St. Petersburg
ZIP/Postal Code
197136
Country
Russian Federation
Facility Name
Glenwood Hospital
City
Durban
Country
South Africa
Facility Name
WITS Medical School, Level 9
City
Parktown
Country
South Africa
Facility Name
401 B Medical Centre
City
Pietermaritzburg
Country
South Africa
Facility Name
Pretoria Urology Hospital, Suite 2, Hatfield
City
Pretoria
Country
South Africa
Facility Name
Sunninghill Clinic, Suite 3
City
Sunninghill
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs