Investigation of a New Trial Drug (FE200486) in Prostate... | NCT00818623 | Trialant
NCT00818623
Sponsor
Ferring Pharmaceuticals
Status
Completed
Last Update Posted
Nov 30, 2023Actual
Enrollment
172Actual
Phase
Phase 2
Conditions
Prostate Cancer
Interventions
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Degarelix
Countries
Denmark
Finland
Hungary
Norway
Romania
Russia
Sweden
Protocol Section
Identification Module
NCT ID
NCT00818623
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
FE200486 CS07
Secondary IDs
Not provided
Brief Title
Investigation of a New Trial Drug (FE200486) in Prostate Cancer Patients
Official Title
An Open-Label, Multi-Center, Parallel and Sequential, Ascending Single Dose Study Investigating the Pharmacokinetics, Pharmacodynamics and Safety of FE200486 in Prostate Cancer Patients
Acronym
Not provided
Organization
Ferring PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
May 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2002
Primary Completion Date
Oct 2004Actual
Completion Date
Oct 2004Actual
First Submitted Date
Jan 7, 2009
First Submission Date that Met QC Criteria
Jan 7, 2009
First Posted Date
Jan 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 22, 2009
Results First Submitted that Met QC Criteria
Mar 30, 2009
Results First Posted Date
Mar 31, 2009Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 8, 2023
Last Update Posted Date
Nov 30, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
Ferring PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this trial was to find an optimal dose for a new trial drug - degarelix (FE200486) - in the treatment of prostate cancer. Furthermore the safety of the drug was studied. Patients participating were treated with FE200486 on one occasion. Thereafter they came in for visits following a specific schedule until blood samples showed that there was no further effect.
Detailed Description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
Conditions Module
Conditions
Prostate Cancer
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
172Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Degarelix 120 mg (20 mg/mL)
Experimental
Degarelix 120 mg (20 mg/mL)
Drug: Degarelix
Degarelix 120 mg (40 mg/mL)
Experimental
Degarelix 120 mg (40 mg/mL)
Drug: Degarelix
Degarelix 160 mg (40 mg/mL)
Experimental
Degarelix 160 mg (40 mg/mL)
Drug: Degarelix
Degarelix 200 mg (40 mg/mL)
Experimental
Degarelix 200 mg (40 mg/mL)
Drug: Degarelix
Degarelix 200 mg (60 mg/mL)
Experimental
Degarelix 200 mg (60 mg/mL)
Drug: Degarelix
Degarelix 240 mg (40 mg/mL)
Experimental
Degarelix 240 mg (40 mg/mL)
Drug: Degarelix
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Degarelix
Drug
Degarelix (120 mg (20 mg/mL)) was given as a subcutaneous injection
Degarelix 120 mg (20 mg/mL)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Time From Dosing Until Testosterone Levels >0.5 ng/mL
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.
3 months
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.
Two - six months
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent obtained before any trial related procedures
Male patient with proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy
ECOG score to be equal to or above 2
Testosterone level within age-specific normal range
PSA value equal to or above 2 ng/ml
Life expectancy of at least 6 months
Exclusion Criteria:
Previous or current hormonal treatment of prostate cancer
Recent or current treatment with any drugs modifying the testosterone level
Candidate for curative treatment such as prostatectomy or radiotherapy
History of severe asthma, anaphylactic reactions or Quincke's Oedema
Hypersensitivity towards any component of FE200486
Cancer disease within the last ten years except for prostate cancer and some skin cancers
Signs of liver impairment shown as elevated serum ALT or serum bilirubin
Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
Presenting with significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder. In addition any other condition such as excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
Mental incapacity or language barrier
Having received an investigational product within the last 12 weeks preceding the trial
Previous participation in this trial
Accepts Healthy Volunteers
No
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Development Support
Ferring Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Rigshospitalet
Copenhagen
Denmark
KAS Glostrup
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
FG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Degarelix 240 mg (60 mg/mL)
Experimental
Degarelix 240 mg (60 mg/mL)
Drug: Degarelix
Degarelix 320 mg (60 mg/mL)
Experimental
Degarelix 320 mg (60 mg/mL)
Drug: Degarelix
FE200486
Degarelix
Drug
Degarelix (120 mg (40 mg/mL)) was given as a subcutaneous injection
Degarelix 120 mg (40 mg/mL)
FE200486
Degarelix
Drug
Degarelix (160 mg (40 mg/mL)) was given as a subcutaneous injection
Degarelix 160 mg (40 mg/mL)
FE200486
Degarelix
Drug
Degarelix (200 mg (40 mg/mL)) was given as a subcutaneous injection
Degarelix 200 mg (40 mg/mL)
FE200486
Degarelix
Drug
Degarelix (200 mg (60 mg/mL)) was given as a subcutaneous injection
Degarelix 200 mg (60 mg/mL)
FE200486
Degarelix
Drug
Degarelix (240 mg (40 mg/mL)) was given as a subcutaneous injection
Degarelix 240 mg (40 mg/mL)
FE200486
Degarelix
Drug
Degarelix (240 mg (60 mg/mL)) was given as a subcutaneous injection
Degarelix 240 mg (60 mg/mL)
FE200486
Degarelix
Drug
Degarelix (320 mg (60 mg/mL)) was given as a subcutaneous injection
Degarelix 320 mg (60 mg/mL)
FE200486
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.
3 months
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.
3 months
Time to 50% Reduction in Prostate-specific Antigen Levels
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
3 months
Time to 90% Reduction in Prostate-specific Antigen Levels
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
3 months
Evaluation of Liver Function Tests
The figures presents 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.
3 months
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.
3 months
Glostrup Municipality
Denmark
KAS Herlev
Herlev
Denmark
Marian Sairaala
Helsinki
Finland
P-K Keskussairaala
Joensuu
Finland
Vuorikadun lääkäriasema
Kuopio
Finland
OYS
Oulu
Finland
Kirugikeskus
Seinäjoki
Finland
TAYS
Tampere
Finland
Bajcsy-Zsilinszky Hospital, Urology
Budapest
Hungary
Jahn Ferenc Dél Pesti Hospital, Urology
Budapest
Hungary
Péterfy Hospital, Urology
Budapest
Hungary
Bács-Kiskun County Hospital, Urology
Kecskemét
Hungary
Hospital of Local Gov. Szeged, Urology
Szeged
Hungary
MÁV Hospital, Urology
Szolnok
Hungary
Sentralsykehuset i Rogland
Stavanger
Norway
CF2 Hospital - Bucharest, Urology
Bucharest
Romania
Dr. Th Burghele Hospital
Bucharest
Romania
Fundeni Hospital - Bucharest, Urology
Bucharest
Romania
County Hospital - Timisoara, Urology
Timișoara
Romania
City Hospital #1, State Med Univ/Urology
Moscow
Russia
Institute of Urology of MoH
Moscow
Russia
Moscow City Hospital #60, Urology
Moscow
Russia
City Hospital #15, Urology Department
Saint Petersburg
Russia
City Hospital #26, Urology Department
Saint Petersburg
Russia
Sahlgrenska Universitetssjukehuset
Gothenburg
Sweden
Helsingborgs Lasaret
Helsingborg
Sweden
Universitetssjukehuset, MAS
Malmö
Sweden
University Hospital, Örebro
Örebro
Sweden
Akademiska Sjukhuset Uppsala
Uppsala
Sweden
FG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
FG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
FG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
FG005
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
FG006
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
FG007
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
FG00026 subjects
FG00112 subjects
FG00213 subjects
FG00324 subjects
FG00427 subjects
FG00524 subjects
FG00627 subjects
FG00727 subjects
Intent-to-treat (ITT) Population
FG00025 subjectsOne participant in this group was randomized but never received any treatment.
FG00112 subjects
FG00212 subjectsOne participant in this group was randomized but never received any treatment.
FG00324 subjects
FG00424 subjectsThree participants in this group were randomized but never received any treatment.
FG00524 subjects
FG00624 subjectsThree participants in this group were randomized but never received any treatment.
FG00727 subjects
COMPLETED
FG00024 subjects
FG0018 subjects
FG0029 subjects
FG00319 subjects
FG00423 subjects
FG00521 subjects
FG00623 subjects
FG00726 subjects
NOT COMPLETED
FG0002 subjects
FG0014 subjects
FG0024 subjects
FG0035 subjects
FG0044 subjects
FG0053 subjects
FG0064 subjects
FG0071 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Bad prostate specific antigen response
FG0000 subjects
FG0013 subjects
FG0022 subjects
FG0035 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Need of additional treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of trial drug at site
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Disease progression
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
BG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
BG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
BG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
BG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
BG005
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
BG006
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
BG007
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00025
BG00112
BG00212
BG00324
BG00424
BG00524
BG00624
BG00727
BG008172
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00070.0± 10.3
BG00173.8± 3.97
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Caucasian
Title
Measurements
BG00025
BG00112
BG002
Curative intent
A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG0000
BG0010
BG002
Gleason score
The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive.
Number
participants
Title
Denominators
Categories
0-1
Title
Measurements
BG0000
BG001
Stage of prostate cancer
Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
Number
participants
Title
Denominators
Categories
Localized
Title
Measurements
BG00010
BG001
Body mass index
Mean
Standard Deviation
kilgram per square meter
Title
Denominators
Categories
Title
Measurements
BG00026.2± 2.97
BG00126.6± 4.58
BG002
Serum prostate-specific antigen levels
Median
Full Range
nanogram per milliliter
Title
Denominators
Categories
Title
Measurements
BG00042.5(3.0 to 4509)
BG00158.8(9.7 to 5514)
BG002
Serum testosterone levels
Median
Full Range
nanogram per milliliter
Title
Denominators
Categories
Title
Measurements
BG0004.30(2.37 to 12.5)
BG0013.10(1.08 to 6.91)
BG002
Time since prostate cancer diagnosis
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG00083.2± 157
BG00165.9± 53.5
BG002
Weight
Mean
Standard Deviation
kilogram
Title
Denominators
Categories
Title
Measurements
BG00077.8± 12.4
BG00182.2± 12.1
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Time From Dosing Until Testosterone Levels >0.5 ng/mL
Intent-to-treat (ITT) population. This outcome measure is based on one testosterone value >0.5 ng/mL at Day 28 onwards.
ITT population.
Posted
Median
95% Confidence Interval
days
3 months
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
OG005
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
OG006
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
OG007
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
Units
Counts
Participants
OG00025
OG00112
OG00212
OG003
Title
Denominators
Categories
Title
Measurements
OG00084(63 to 119)
OG00163(28 to 133)
OG00270(28 to 98)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
OG006
OG007
Log Rank
0.0000586
95
Superiority or Other (legacy)
Secondary
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 28 Days
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 28 days.
ITT population.
Posted
Number
participants
Two - six months
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
OG005
Secondary
Number of Participants With Testosterone Level ≤0.5 ng/mL for at Least 84 Days
The table shows the number of participants with testosterone level ≤0.5 ng/mL for at least 84 days.
ITT population.
Posted
Number
participants
3 months
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
OG005
Secondary
Time to Testosterone Castration (Testosterone ≤0.5 ng/mL)
Time to testosterone castration was calculated as the number of days from dosing to the first scheduled visit when testosterone was less than 0.5 ng/mL.
ITT population
Posted
Median
Full Range
days
3 months
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
Secondary
Time to 50% Reduction in Prostate-specific Antigen Levels
The time to 50% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 50% reduction in PSA level was reached.
ITT population. Patients who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.
Posted
Median
Full Range
days
3 months
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
Degarelix 200mg (60mg/mL)
Secondary
Time to 90% Reduction in Prostate-specific Antigen Levels
The time to 90% prostate-specific antigen (PSA) reduction from baseline was defined as the number of days from dosing to the first visit where a 90% reduction in PSA level was reached.
ITT population. Participants who did not achieve the actual level of reduction were censored as of the time from dosing for the last available observation.
Posted
Median
Full Range
days
3 months
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
Degarelix 200mg (60mg/mL)
Secondary
Evaluation of Liver Function Tests
The figures presents 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
Number
participants
3 months
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
OG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
Secondary
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.
ITT population. The first value in the category represents the actual clinical reading and the second is the change from baseline for blood pressure (units: millimeters of mercury) and heart rate (units:beats per minute). The weight category includes participants whose percent weight change from baseline fit the stated ranges.
Posted
Number
participants
3 months
ID
Title
Description
OG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
OG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
OG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
OG003
Degarelix 200mg (40mg/mL)
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Degarelix 120mg (20mg/mL)
Degarelix 120 mg (20 mg/mL)
2
14
EG001
Degarelix 120mg (40mg/mL)
Degarelix 120 mg (40 mg/mL)
2
10
EG002
Degarelix 160mg (40mg/mL)
Degarelix 160 mg (40 mg/mL)
1
7
EG003
Degarelix 200mg (40mg/mL)
Degarelix 200 mg (40 mg/mL)
2
20
EG004
Degarelix 200mg (60mg/mL)
Degarelix 200 mg (60 mg/mL)
1
14
EG005
Degarelix 240mg (40mg/mL)
Degarelix 240 mg (40 mg/mL)
4
22
EG006
Degarelix 240mg (60mg/mL)
Degarelix 240 mg (60 mg/mL)
3
10
EG007
Degarelix 320mg (60mg/mL)
Degarelix 320 mg (60 mg/mL)
4
19
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cardiac failure
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG0031 events1 affected24 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected24 at risk
EG0060 events0 affected24 at risk
EG0070 events0 affected27 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Condition aggravated
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Oedema
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hepatitis toxic
Hepatobiliary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gangrene
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Inervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastases to liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Metastatic pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Areflexia
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Paraplegia
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Depression
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Amputation revision
Surgical and medical procedures
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG0030 events0 affected24 at risk
EG0040 events0 affected24 at risk
EG0050 events0 affected24 at risk
EG0061 events1 affected24 at risk
EG0072 events2 affected27 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Cataract
Eye disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Glaucoma
Eye disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Stomach discomfort
Gastrointestinal disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site pain
General disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0012 events2 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Injection site erythema
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Fatigue
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chest pain
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Chills
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Feeling of body temperature change
General disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site induration
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site pruritus
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Oedema peripheral
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Injection site swelling
General disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0003 events3 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Cystitis
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Oral fungal infection
Infections and infestations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0003 events3 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0003 events3 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0004 events4 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Blood pressure increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Prostatic specific antigen increased
Investigations
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0002 events2 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0022 events1 affected12 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 7.0
Systematic Assessment
EG0001 events1 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 7.0
Systematic Assessment
EG0006 events6 affected25 at risk
EG0012 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0012 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Hot flush
Vascular disorders
MedDRA 7.0
Systematic Assessment
EG0004 events4 affected25 at risk
EG0011 events1 affected12 at risk
EG0024 events3 affected12 at risk
EG003
Flushing
Vascular disorders
MedDRA 7.0
Systematic Assessment
EG0000 events0 affected25 at risk
EG0011 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.