Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer
Sponsor
Ferring Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00268892
Collaborator
(none)
278
23
3
47
12.1
0.3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2/Phase 3 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
278 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens in Patients With Prostate Cancer
Study Start Date
:
Jan 1, 2006
Actual Primary Completion Date
:
Sep 1, 2009
Actual Study Completion Date
:
Dec 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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.
Other Names:
|
| 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
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.
Other Names:
|
| 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight [Baseline and up to 4.5 years]
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 [4.5 years]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UZ Gasthuisberg Leuven | Leuven | Belgium | ||
| 2 | Helsinki University Hospital, Maria Hospital, Building 11 | Helsinki | Finland | ||
| 3 | Central Hospital, North Karelian | Joensuu | Finland | ||
| 4 | Oulu University Hospital | Oulu | Finland | ||
| 5 | Tampere University Hospital | Tampere | Finland | ||
| 6 | Fédération d'Urologie et Néphrologie, BP69 Hôpital Pasteur | Nice | France | ||
| 7 | Gemeinschaftspraxis Dres Effert und Benedic | Aachen | Germany | ||
| 8 | Clinical Center Novi Sad, Clinic of Urology | Novi Sad | Montenegro | ||
| 9 | Academic Medical Center, Urology | Amsterdam | Netherlands | ||
| 10 | St. Elisabeth Hospital | Tilburg | Netherlands | ||
| 11 | "Centrul Medical Privat" Prof. Dr. Ioiart Ioan" | Arad | Romania | ||
| 12 | Clinical Hospital "Prof. Dr. Theodor Burghele", Urology Department | Bucharest | Romania | ||
| 13 | University CF Hospital No. 2 | Bucharest | Romania | ||
| 14 | Andros Clinic | St. Petersburg | Russian Federation | ||
| 15 | City Hospital #15 | St. Petersburg | Russian Federation | ||
| 16 | City Hospital #26 | St. Petersburg | Russian Federation | ||
| 17 | Pavlov State Medical University, Outpatient Diagnostic Center affiliated with the Urology Department | St. Petersburg | Russian Federation | ||
| 18 | Pavlov State Medical University, Urology Department | St. Petersburg | Russian Federation | ||
| 19 | Clinical Center of Serbia, Institute of Urology and Nephrology | Belgrade | Serbia | ||
| 20 | Mount Vernon Cancer Centre, Marie Cuire Research Wing | Northwood | Middlesex | United Kingdom | |
| 21 | Castle Hill Hospital | Hull | North Humberside | United Kingdom | |
| 22 | Ward 13, NHS Forth Valley Acute Operating Division, Falkirk and District Royal Infirmary, Majors Loans | Falkirk | United Kingdom | ||
| 23 | Level 7, Urology Research Unit, Derriford Hospital | Plymouth | United Kingdom |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Clinical Development Support, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00268892
Other Study ID Numbers:
- FE200486 CS15A
First Posted:
Dec 23, 2005
Last Update Posted:
Dec 24, 2010
Last Verified:
Dec 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 447 participants started and 374 participants completed the main CS15 study. Of these, 278 participants were recruited into the extension study CS15A and 203 participants signed the informed consent for dose shift. |
| Arm/Group Title | Degarelix 240/240@40(1-3-6-9) | Degarelix 240/240@60(1-3-6-9) | Degarelix 240/240@60(1-4-7-10) |
|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). |
| Period Title: Overall Study | |||
| STARTED | 90 | 95 | 93 |
| Switched to Higher Dose | 59 | 68 | 76 |
| COMPLETED | 51 | 53 | 54 |
| NOT COMPLETED | 39 | 42 | 39 |
Baseline Characteristics
| Arm/Group Title | 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 |
|---|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). | Total of all reporting groups |
| Overall Participants | 90 | 95 | 93 | 278 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
72.7
(6.55)
|
73.3
(7.00)
|
71.8
(7.05)
|
72.6
(6.88)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
90
100%
|
95
100%
|
93
100%
|
278
100%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
1.1%
|
1
0.4%
|
| Asian |
0
0%
|
1
1.1%
|
1
1.1%
|
2
0.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
3
3.3%
|
5
5.3%
|
3
3.2%
|
11
4%
|
| White |
87
96.7%
|
89
93.7%
|
88
94.6%
|
264
95%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Body Weight (kilogram) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kilogram] |
76.7
(13.0)
|
76.9
(12.2)
|
76.5
(12.8)
|
76.7
(12.6)
|
| Body Mass Index (kilogram per square meter) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kilogram per square meter] |
25.4
(4.14)
|
25.8
(3.93)
|
25.8
(4.16)
|
25.7
(4.07)
|
| Curative Intent (participants) [Number] | ||||
| Yes |
10
11.1%
|
12
12.6%
|
7
7.5%
|
29
10.4%
|
| No |
80
88.9%
|
83
87.4%
|
86
92.5%
|
249
89.6%
|
| Gleason Score (participants) [Number] | ||||
| 2-4 |
13
14.4%
|
6
6.3%
|
13
14%
|
32
11.5%
|
| 5-6 |
33
36.7%
|
30
31.6%
|
34
36.6%
|
97
34.9%
|
| 7-10 |
44
48.9%
|
58
61.1%
|
46
49.5%
|
148
53.2%
|
| Stage of Prostate Cancer (participants) [Number] | ||||
| Localized |
34
37.8%
|
37
38.9%
|
36
38.7%
|
107
38.5%
|
| Locally Advanced |
26
28.9%
|
26
27.4%
|
28
30.1%
|
80
28.8%
|
| Metastatic |
16
17.8%
|
19
20%
|
20
21.5%
|
55
19.8%
|
| Not Classifiable |
14
15.6%
|
13
13.7%
|
9
9.7%
|
36
12.9%
|
| Time since Prostate Cancer Diagnosis (days) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [days] |
469
(1079)
|
347
(824)
|
255
(583)
|
356
(852)
|
Outcome Measures
| Title | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight |
|---|---|
| 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. |
| Time Frame | Baseline and up to 4.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The data include data from participants participating in both the main study (FE200486 CS15) and the extension study FE200486 CS15A. |
| Arm/Group Title | Degarelix 240/240@40(1-3-6-9) | Degarelix 240/240@60(1-3-6-9) | Degarelix 240/240@60(1-4-7-10) |
|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). |
| Measure Participants | 90 | 95 | 93 |
| Diastolic blood pressure <=50 and decrease >=15 |
5
5.6%
|
6
6.3%
|
4
4.3%
|
| Diastolic blood pressure >=105 and increase >=15 |
7
7.8%
|
6
6.3%
|
8
8.6%
|
| Systolic blood pressure <=90 and decrease >=20 |
1
1.1%
|
1
1.1%
|
2
2.2%
|
| Systolic blood pressure >=180 and increase >=20 |
8
8.9%
|
11
11.6%
|
10
10.8%
|
| Heart rate <=50 and decrease >=15 |
9
10%
|
10
10.5%
|
5
5.4%
|
| Heart rate >=120 and increase >=15 |
1
1.1%
|
4
4.2%
|
1
1.1%
|
| Body weight decrease of >=7 percent |
7
7.8%
|
8
8.4%
|
4
4.3%
|
| Body weight increase of >=7 percent |
32
35.6%
|
35
36.8%
|
41
44.1%
|
| 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 | 4.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Degarelix 240/240@40(1-3-6-9) | Degarelix 240/240@60(1-3-6-9) | Degarelix 240/240@60(1-4-7-10) |
|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). |
| Measure Participants | 90 | 95 | 93 |
| Abnormal alanine aminotransferase (ALAT) |
22
24.4%
|
22
23.2%
|
17
18.3%
|
| Abnormal aspartate aminotransferase |
18
20%
|
25
26.3%
|
19
20.4%
|
| Abnormal bilirubin |
4
4.4%
|
5
5.3%
|
3
3.2%
|
| ALAT >3x upper limit of normal (ULN) |
3
3.3%
|
2
2.1%
|
3
3.2%
|
| ALAT >3x ULN, bilirubin >1.5x ULN |
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | 4.5 years. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Each participant's condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant's Case Report Form. | |||||
| Arm/Group Title | Degarelix 240/240@40(1-3-6-9) | Degarelix 240/240@60(1-3-6-9) | Degarelix 240/240@60(1-4-7-10) | |||
| Arm/Group Description | 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). | 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). | 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). | |||
All Cause Mortality |
||||||
| Degarelix 240/240@40(1-3-6-9) | Degarelix 240/240@60(1-3-6-9) | Degarelix 240/240@60(1-4-7-10) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Degarelix 240/240@40(1-3-6-9) | Degarelix 240/240@60(1-3-6-9) | Degarelix 240/240@60(1-4-7-10) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 30/90 (33.3%) | 24/95 (25.3%) | 21/93 (22.6%) | |||
| Cardiac disorders | ||||||
| Myocardial ischaemia | 1/90 (1.1%) | 1 | 1/95 (1.1%) | 1 | 1/93 (1.1%) | 1 |
| Acute myocardial infarction | 2/90 (2.2%) | 2 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Atrial fibrillation | 1/90 (1.1%) | 1 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Cardiac Failure | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Angina Pectoris | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Artrial Flutter | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Atrioventricular block complete | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Cardiac arrest | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Cardio-respiratory arrest | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Coronary artery disease | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Coronary artery stenosis | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Right ventricular failure | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Sick sinus syndrome | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Endocrine disorders | ||||||
| Hypoparathyroidism | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Eye disorders | ||||||
| Eye haemorrhage | 0/90 (0%) | 0 | 1/95 (1.1%) | 2 | 0/93 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Constipation | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 1/93 (1.1%) | 1 |
| Volvulus | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 1/93 (1.1%) | 1 |
| Vomiting | 1/90 (1.1%) | 1 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Abdominal pain | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Abdominal pain lower | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Crohn's disease | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Gastritis | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Gastrointestinal haemorrhage | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Gastrointestinal hypomotility | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Gastrointestinal necrosis | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Haematemesis | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Haemorrhoids | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Ileus | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Inguinal hernia | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Intestinal infarction | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Pancreatic cyst | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| General disorders | ||||||
| Disease progression | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Pyrexia | 1/90 (1.1%) | 1 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Adverse drug reaction | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Fatigue | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Sudden death | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Hepatobiliary disorders | ||||||
| Cholecystitis acute | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Infections and infestations | ||||||
| Erysipelas | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 1/93 (1.1%) | 1 |
| Appendicitis | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Cellulitis | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Gastroenteritis | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Mycotoxicosis | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Pneumonia | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Pyelonephritis | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Pyelonephritis acute | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Respiratory tract infection | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Staphylococcal sepsis | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Urinary tract infection | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Hip fracture | 3/90 (3.3%) | 3 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Hand fracture | 1/90 (1.1%) | 1 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Ankle fracture | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Brain contusion | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Femur fracture | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Joint dislocation | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Post procedural haematuria | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Radius fracture | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Rib fracture | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Subdural haematoma | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Ulna fracture | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Investigations | ||||||
| Blood pressure increased | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Investigation | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Prostatic specific antigen increased | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Osteoarthiritis | 1/90 (1.1%) | 1 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Arthralgia | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 2 |
| Osteoporotic fracture | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Pathological fracture | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Rhabdomyolysis | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Prostate cancer metastatic | 2/90 (2.2%) | 2 | 1/95 (1.1%) | 1 | 1/93 (1.1%) | 1 |
| Prostate cancer | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 2/93 (2.2%) | 2 |
| Bladder transitional cell | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Carcinoma | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Lung neoplasm | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Lymphoma | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Metastates to spine | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Metastatic pain | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Rectal cancer | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Throat cancer | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Nervous system disorders | ||||||
| Cerebrovascular accident | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 1/93 (1.1%) | 1 |
| Cerebal infarction | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Cerebrovascular disorder | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Dementia Alzheimer's type | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Dizziness | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Haemorrhagic stroke | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Hemiparesis | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Ischaemic stroke | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Paraplegia | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Transient ischaemic attack | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Presyncope | 0/90 (0%) | 0 | 1/95 (1.1%) | 2 | 0/93 (0%) | 0 |
| Psychiatric disorders | ||||||
| Agitation | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Confusional state | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Renal and urinary disorders | ||||||
| Urinary retention | 7/90 (7.8%) | 7 | 3/95 (3.2%) | 3 | 0/93 (0%) | 0 |
| Haematuria | 0/90 (0%) | 0 | 2/95 (2.1%) | 2 | 1/93 (1.1%) | 1 |
| Hydronephrosis | 0/90 (0%) | 0 | 2/95 (2.1%) | 4 | 1/93 (1.1%) | 1 |
| Bladder tamponade | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 1 |
| Calculus ureteric | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Renal colic | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Renal failure acute | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Urethral stenosis | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Urinary bladder polyp | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Urinary incontinence | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Chronic obstructive pulmonary disease | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 2/93 (2.2%) | 2 |
| Pulmonary embolism | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 1/93 (1.1%) | 1 |
| Cough | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Epistaxis | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Hyperhidrosis | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Stasis dermatitis | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
| Vascular disorders | ||||||
| Arterial disorder | 0/90 (0%) | 0 | 0/95 (0%) | 0 | 1/93 (1.1%) | 2 |
| Arterial stenosis limb | 0/90 (0%) | 0 | 1/95 (1.1%) | 1 | 0/93 (0%) | 0 |
| Hypotension | 1/90 (1.1%) | 1 | 0/95 (0%) | 0 | 0/93 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| Degarelix 240/240@40(1-3-6-9) | Degarelix 240/240@60(1-3-6-9) | Degarelix 240/240@60(1-4-7-10) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 72/90 (80%) | 75/95 (78.9%) | 69/93 (74.2%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 5/90 (5.6%) | 6 | 7/95 (7.4%) | 7 | 5/93 (5.4%) | 6 |
| Cardiac disorders | ||||||
| Atrial Fibrillation | 7/90 (7.8%) | 12 | 9/95 (9.5%) | 14 | 6/93 (6.5%) | 6 |
| Eye disorders | ||||||
| Cataract | 6/90 (6.7%) | 8 | 1/95 (1.1%) | 1 | 3/93 (3.2%) | 3 |
| Gastrointestinal disorders | ||||||
| Abdominal Pain | 7/90 (7.8%) | 10 | 6/95 (6.3%) | 7 | 4/93 (4.3%) | 4 |
| Nausea | 5/90 (5.6%) | 6 | 10/95 (10.5%) | 15 | 2/93 (2.2%) | 2 |
| Constipation | 4/90 (4.4%) | 4 | 6/95 (6.3%) | 6 | 3/93 (3.2%) | 8 |
| Diarrhoea | 4/90 (4.4%) | 4 | 4/95 (4.2%) | 6 | 5/93 (5.4%) | 8 |
| Vomiting | 3/90 (3.3%) | 4 | 5/95 (5.3%) | 8 | 1/93 (1.1%) | 5 |
| General disorders | ||||||
| Injection Site Pain | 24/90 (26.7%) | 55 | 24/95 (25.3%) | 64 | 16/93 (17.2%) | 36 |
| Injection Site Erythema | 15/90 (16.7%) | 29 | 14/95 (14.7%) | 32 | 6/93 (6.5%) | 8 |
| Pyrexia | 12/90 (13.3%) | 31 | 9/95 (9.5%) | 20 | 7/93 (7.5%) | 22 |
| Fatigue | 10/90 (11.1%) | 13 | 9/95 (9.5%) | 14 | 8/93 (8.6%) | 8 |
| Injection Site Swelling | 5/90 (5.6%) | 12 | 10/95 (10.5%) | 26 | 3/93 (3.2%) | 3 |
| Injection Site Induration | 7/90 (7.8%) | 7 | 4/95 (4.2%) | 5 | 4/93 (4.3%) | 8 |
| Oedema Peripheral | 4/90 (4.4%) | 4 | 6/95 (6.3%) | 6 | 4/93 (4.3%) | 4 |
| Injection Site Nodule | 6/90 (6.7%) | 8 | 3/95 (3.2%) | 7 | 4/93 (4.3%) | 6 |
| Injection Site Mass | 5/90 (5.6%) | 10 | 2/95 (2.1%) | 2 | 1/93 (1.1%) | 1 |
| Injection Site Pruritus | 5/90 (5.6%) | 6 | 2/95 (2.1%) | 3 | 1/93 (1.1%) | 7 |
| Urinary Tract Infection | 6/90 (6.7%) | 8 | 9/95 (9.5%) | 17 | 6/93 (6.5%) | 6 |
| Nasopharyngitis | 5/90 (5.6%) | 10 | 9/95 (9.5%) | 16 | 3/93 (3.2%) | 5 |
| Influenza | 4/90 (4.4%) | 4 | 5/95 (5.3%) | 5 | 7/93 (7.5%) | 9 |
| Aspartate Aminotransferase Increase | 4/90 (4.4%) | 4 | 3/95 (3.2%) | 4 | 5/93 (5.4%) | 5 |
| Investigations | ||||||
| Weight Increased | 11/90 (12.2%) | 12 | 9/95 (9.5%) | 10 | 7/93 (7.5%) | 7 |
| Alanine Aminotransferase Increased | 6/90 (6.7%) | 6 | 5/95 (5.3%) | 6 | 5/93 (5.4%) | 5 |
| Weight Decreased | 4/90 (4.4%) | 4 | 7/95 (7.4%) | 7 | 4/93 (4.3%) | 4 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 10/90 (11.1%) | 13 | 7/95 (7.4%) | 10 | 6/93 (6.5%) | 14 |
| Back Pain | 9/90 (10%) | 10 | 5/95 (5.3%) | 7 | 6/93 (6.5%) | 12 |
| Musculoskeletal Pain | 5/90 (5.6%) | 5 | 1/95 (1.1%) | 2 | 3/93 (3.2%) | 6 |
| Nervous system disorders | ||||||
| Dizziness | 7/90 (7.8%) | 9 | 9/95 (9.5%) | 12 | 4/93 (4.3%) | 6 |
| Headache | 5/90 (5.6%) | 7 | 4/95 (4.2%) | 4 | 3/93 (3.2%) | 20 |
| Psychiatric disorders | ||||||
| Insomnia | 2/90 (2.2%) | 3 | 7/95 (7.4%) | 7 | 1/93 (1.1%) | 1 |
| Renal and urinary disorders | ||||||
| Urinary retention | 2/90 (2.2%) | 2 | 5/95 (5.3%) | 6 | 2/93 (2.2%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||
| Hyperhidrosis | 2/90 (2.2%) | 3 | 5/95 (5.3%) | 5 | 3/93 (3.2%) | 4 |
| Rash | 1/90 (1.1%) | 3 | 5/95 (5.3%) | 9 | 0/93 (0%) | 0 |
| Vascular disorders | ||||||
| Hot Flush | 31/90 (34.4%) | 33 | 27/95 (28.4%) | 29 | 32/93 (34.4%) | 38 |
| Hypertension | 4/90 (4.4%) | 5 | 6/95 (6.3%) | 6 | 5/93 (5.4%) | 5 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
Results Point of Contact
| Name/Title | Ferring Pharmaceuticals |
|---|---|
| Organization | Clinical Development Support |
| Phone | |
| DK0-Disclosure@ferring.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00268892
Other Study ID Numbers:
- FE200486 CS15A
First Posted:
Dec 23, 2005
Last Update Posted:
Dec 24, 2010
Last Verified:
Dec 1, 2010