Trial Outcomes & Findings for A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer (NCT NCT00116779)
NCT ID: NCT00116779
Last Updated: 2011-12-19
Results Overview
Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
Day 28 to Day 364
Results posted on
2011-12-19
Participant Flow
One hundred and seventy-six patients were screened to identify the one hundred and twenty-seven patients who were eligible for randomization.
Participant milestones
| Measure |
Degarelix 60mg
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
64
|
|
Overall Study
COMPLETED
|
42
|
45
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
| Measure |
Degarelix 60mg
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
2
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Inadequate testosterone suppression
|
7
|
9
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Elevated PSA levels
|
2
|
2
|
Baseline Characteristics
A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age Continuous
|
74.8 years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
74.9 years
STANDARD_DEVIATION 9.55 • n=7 Participants
|
74.9 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Curative Intent
No
|
41 participants
n=5 Participants
|
40 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Curative Intent
Yes
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Participant Counts by Gleason Score
2-4
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Participant Counts by Gleason Score
5-6
|
19 participants
n=5 Participants
|
22 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Participant Counts by Gleason Score
7-10
|
41 participants
n=5 Participants
|
39 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
The Number of Participants at Each Stage of Prostate Cancer
Localized
|
31 participants
n=5 Participants
|
23 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
The Number of Participants at Each Stage of Prostate Cancer
Locally advanced
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
The Number of Participants at Each Stage of Prostate Cancer
Metastatic
|
15 participants
n=5 Participants
|
9 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
The Number of Participants at Each Stage of Prostate Cancer
Not classifiable
|
12 participants
n=5 Participants
|
23 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Body Mass Index
|
27.3 kilogram per square meter
FULL_RANGE 4.1 • n=5 Participants
|
26.7 kilogram per square meter
FULL_RANGE 3.98 • n=7 Participants
|
27 kilogram per square meter
FULL_RANGE 4.03 • n=5 Participants
|
|
Days Since Diagnosis of Prostate Cancer
|
1213 days
STANDARD_DEVIATION 1597 • n=5 Participants
|
1256 days
STANDARD_DEVIATION 1550 • n=7 Participants
|
1234 days
STANDARD_DEVIATION 1568 • n=5 Participants
|
|
Serum Prostate-Specific Antigen
|
12.7 nanograms/milliliter
n=5 Participants
|
13.7 nanograms/milliliter
n=7 Participants
|
13.4 nanograms/milliliter
n=5 Participants
|
|
Serum Testosterone level
|
4.1 nanograms/milliliter
n=5 Participants
|
4.23 nanograms/milliliter
n=7 Participants
|
4.13 nanograms/milliliter
n=5 Participants
|
|
Weight
|
83 Kilograms
STANDARD_DEVIATION 14.6 • n=5 Participants
|
81.2 Kilograms
STANDARD_DEVIATION 12.7 • n=7 Participants
|
82.1 Kilograms
STANDARD_DEVIATION 13.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 to Day 364Population: ITT population of patients who completed the study and had testosterone \<=0.5 nanogram per milliliter at Day 28.
Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364
Outcome measures
| Measure |
Degarelix 60mg
n=49 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=53 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
|
42 participants
Interval 73.0 to 94.0
|
41 participants
Interval 64.0 to 88.0
|
PRIMARY outcome
Timeframe: Day 28 - Day 364Population: ITT population of participants who completed the study and had a testosterone level of \<=0.5 nanogram per milliliter at Day 28.
Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.
Outcome measures
| Measure |
Degarelix 60mg
n=45 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=42 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28
|
42 participants
Interval 82.0 to 99.0
|
41 participants
Interval 87.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 3Population: ITT population
Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.
Outcome measures
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.
|
54 participants
Interval 79.0 to 96.0
|
56 participants
Interval 78.0 to 95.0
|
SECONDARY outcome
Timeframe: Day 0 (post dose) to Day 364Population: ITT population
Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.
Outcome measures
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
50 percent reduction (n=59, 59)
|
14 days
Interval 3.0 to 84.0
|
14 days
Interval 1.0 to 56.0
|
|
Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
90 percent reduction (n=45, 48)
|
56 days
Interval 28.0 to 168.0
|
56 days
Interval 14.0 to 252.0
|
SECONDARY outcome
Timeframe: Day 0 (post dose) to Day 364Population: ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.
Median days to prostate-specific antigen increase of \>= 50 percent and \>= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.
Outcome measures
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Days to Prostate-Specific Antigen Progression
|
196 days
Interval 107.0 to 280.0
|
154 days
Interval 28.0 to 308.0
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 3, 7, 14Population: ITT population
Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14
Outcome measures
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Median Di-Hydrotestosterone Levels At Various Study Timepoints
Baseline (n=63, 64)
|
360 picogram / milliliter
Interval 10.0 to 800.0
|
350 picogram / milliliter
Interval 48.0 to 810.0
|
|
Median Di-Hydrotestosterone Levels At Various Study Timepoints
Day 1 (n=62, 62)
|
110 picogram / milliliter
Interval 37.0 to 350.0
|
120 picogram / milliliter
Interval 34.0 to 280.0
|
|
Median Di-Hydrotestosterone Levels At Various Study Timepoints
Day 3 (n=58, 63)
|
56.5 picogram / milliliter
Interval 10.0 to 230.0
|
57 picogram / milliliter
Interval 10.0 to 150.0
|
|
Median Di-Hydrotestosterone Levels At Various Study Timepoints
Day 7 (n=58, 63)
|
45.5 picogram / milliliter
Interval 20.0 to 150.0
|
52 picogram / milliliter
Interval 10.0 to 280.0
|
|
Median Di-Hydrotestosterone Levels At Various Study Timepoints
Day 14 (n=61, 61)
|
37 picogram / milliliter
Interval 10.0 to 230.0
|
40 picogram / milliliter
Interval 10.0 to 430.0
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 14, 28, 84, 364Population: ITT population
Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.
Outcome measures
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Median Prostate-Specific Antigen Values at Various Study Timepoints
Baseline (n=63, 64)
|
12.7 nanogram / milliliter
Interval 2.7 to 759.0
|
13.7 nanogram / milliliter
Interval 1.6 to 1942.0
|
|
Median Prostate-Specific Antigen Values at Various Study Timepoints
Day 3 (n=60, 64)
|
11.4 nanogram / milliliter
Interval 2.1 to 1557.0
|
12.2 nanogram / milliliter
Interval 1.3 to 1206.0
|
|
Median Prostate-Specific Antigen Values at Various Study Timepoints
Day 14 (n=61, 63)
|
6.4 nanogram / milliliter
Interval 0.9 to 362.0
|
6.8 nanogram / milliliter
Interval 0.9 to 182.0
|
|
Median Prostate-Specific Antigen Values at Various Study Timepoints
Day 28 (n=61, 63)
|
2.9 nanogram / milliliter
Interval 0.3 to 28.8
|
3.6 nanogram / milliliter
Interval 0.3 to 127.0
|
|
Median Prostate-Specific Antigen Values at Various Study Timepoints
Day 84 (n=57, 54)
|
0.8 nanogram / milliliter
Interval 0.0 to 32.1
|
0.7 nanogram / milliliter
Interval 0.0 to 104.0
|
|
Median Prostate-Specific Antigen Values at Various Study Timepoints
Day 364 (n=42, 43)
|
0.4 nanogram / milliliter
Interval 0.0 to 12.8
|
0.2 nanogram / milliliter
Interval 0.0 to 39.8
|
SECONDARY outcome
Timeframe: Baseline, Days 1, 3, 7, 14Population: ITT population
Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.
Outcome measures
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Median Luteinizing Hormone Levels at Various Study Timeframes
Baseline (n=63, 64)
|
5.28 international units / liter
Interval 1.22 to 25.0
|
5.33 international units / liter
Interval 0.72 to 31.0
|
|
Median Luteinizing Hormone Levels at Various Study Timeframes
Day 1 (n=58, 61)
|
0.915 international units / liter
Interval 0.22 to 5.21
|
0.87 international units / liter
Interval 0.035 to 5.64
|
|
Median Luteinizing Hormone Levels at Various Study Timeframes
Day 3 (n=59, 60)
|
0.43 international units / liter
Interval 0.035 to 2.05
|
0.425 international units / liter
Interval 0.035 to 1.78
|
|
Median Luteinizing Hormone Levels at Various Study Timeframes
Day 7 (n=60, 61)
|
0.41 international units / liter
Interval 0.035 to 2.64
|
0.6 international units / liter
Interval 0.035 to 7.35
|
|
Median Luteinizing Hormone Levels at Various Study Timeframes
Day 14 (n=61, 62)
|
0.2 international units / liter
Interval 0.035 to 3.5
|
0.37 international units / liter
Interval 0.035 to 9.5
|
SECONDARY outcome
Timeframe: Baseline, Days 1,3,7,14,364Population: ITT population
Testosterone levels at baseline and days 1, 3, 7, 14 and 364
Outcome measures
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Median Testosterone Levels at Various Days During the Study
Baseline (n=63, 64)
|
4.1 nanograms / milliliter
Interval 1.51 to 11.0
|
4.23 nanograms / milliliter
Interval 0.2 to 8.68
|
|
Median Testosterone Levels at Various Days During the Study
Day 1 (n=61, 63)
|
0.56 nanograms / milliliter
Interval 0.2 to 2.49
|
0.71 nanograms / milliliter
Interval 0.12 to 2.98
|
|
Median Testosterone Levels at Various Days During the Study
Day 3 (n=60, 63)
|
0.26 nanograms / milliliter
Interval 0.13 to 0.67
|
0.31 nanograms / milliliter
Interval 0.11 to 1.31
|
|
Median Testosterone Levels at Various Days During the Study
Day 7 (n=60, 64)
|
0.18 nanograms / milliliter
Interval 0.08 to 1.46
|
0.24 nanograms / milliliter
Interval 0.07 to 3.98
|
|
Median Testosterone Levels at Various Days During the Study
Day 14 (n=61, 63)
|
0.11 nanograms / milliliter
Interval 0.04 to 2.19
|
0.14 nanograms / milliliter
Interval 0.015 to 6.99
|
|
Median Testosterone Levels at Various Days During the Study
Day 364 (n=42, 43)
|
0.07 nanograms / milliliter
Interval 0.015 to 0.45
|
0.07 nanograms / milliliter
Interval 0.015 to 0.32
|
SECONDARY outcome
Timeframe: Day 1 through day 364Population: ITT population
Participants whose alanine aminotransferase values were at levels above the normal range.
Outcome measures
| Measure |
Degarelix 60mg
n=62 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Number of Participants With Abnormal Alanine Aminotransferase Values
> upper limit and 3 times upper limit
|
10 participants
|
21 participants
|
|
Number of Participants With Abnormal Alanine Aminotransferase Values
Total abnormal (> upper limit)
|
10 participants
|
21 participants
|
|
Number of Participants With Abnormal Alanine Aminotransferase Values
Total normal (<=upper limit)
|
52 participants
|
43 participants
|
SECONDARY outcome
Timeframe: Day 1 - 364Population: ITT population
Participants with aspartate aminotransferase values that were above the normal range.
Outcome measures
| Measure |
Degarelix 60mg
n=62 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Number of Participants With Abnormal Aspartate Aminotransferase Values
> 3 times upper limit - 5 times upper limit
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Aspartate Aminotransferase Values
> upper limit - 3 times upper limit
|
6 participants
|
5 participants
|
|
Number of Participants With Abnormal Aspartate Aminotransferase Values
Total Abnormal (> upper limit)
|
6 participants
|
6 participants
|
|
Number of Participants With Abnormal Aspartate Aminotransferase Values
Total Normal (<= upper limit)
|
56 participants
|
58 participants
|
SECONDARY outcome
Timeframe: Day 1 - 364Population: ITT population
Participants with abnormal total bilirubin values
Outcome measures
| Measure |
Degarelix 60mg
n=62 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Number of Participants With Abnormal Total Bilirubin Values
>2 times upper limit
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Total Bilirubin Values
>1.5 times upper limit
|
2 participants
|
4 participants
|
|
Number of Participants With Abnormal Total Bilirubin Values
> upper limit - 1.5 times upper limit
|
12 participants
|
9 participants
|
|
Number of Participants With Abnormal Total Bilirubin Values
Total abnormal (> upper limit)
|
14 participants
|
14 participants
|
|
Number of Participants With Abnormal Total Bilirubin Values
Total normal (<=upper limit)
|
48 participants
|
50 participants
|
SECONDARY outcome
Timeframe: Day 364Population: ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61
Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.
Outcome measures
| Measure |
Degarelix 60mg
n=63 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
n=64 Participants
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Diastolic blood pressure <= 50 and decrease >= 15
|
7 participants
|
5 participants
|
|
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Diastolic blood pressure >= 105 and increase >= 15
|
1 participants
|
2 participants
|
|
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Pulse <=50 and decrease of >=15
|
2 participants
|
5 participants
|
|
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Pulse >=120 and increase of >=15
|
0 participants
|
0 participants
|
|
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Systolic blood pressure <=90 and decrease >=20
|
5 participants
|
5 participants
|
|
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Systolic blood pressure >=180 and increase >=20
|
6 participants
|
7 participants
|
|
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Weight decrease of >=7 percent
|
2 participants
|
3 participants
|
|
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
Weight increase of >= 7 percent
|
7 participants
|
4 participants
|
Adverse Events
Degarelix 60mg
Serious events: 9 serious events
Other events: 55 other events
Deaths: 0 deaths
Degarelix 80mg
Serious events: 6 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 60mg
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/63 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/63
|
1.6%
1/64 • Number of events 1
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/63
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/63
|
1.6%
1/64 • Number of events 1
|
|
General disorders
Injection site urticaria
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/63
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
1.6%
1/63 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Orchitis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Perirectal abscess
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Infections and infestations
Pseudomembranous colitis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Nervous system disorders
Grand mal convulsion
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Nervous system disorders
Transient ischaemic attack
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/63
|
1.6%
1/64 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
1/63 • Number of events 1
|
0.00%
0/64
|
Other adverse events
| Measure |
Degarelix 60mg
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
|
Degarelix 80mg
Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
3/63 • Number of events 3
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
6.3%
4/63 • Number of events 4
|
6.2%
4/64 • Number of events 4
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
3/63 • Number of events 3
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
4.8%
3/63 • Number of events 4
|
3.1%
2/64 • Number of events 2
|
|
General disorders
Fatigue
|
15.9%
10/63 • Number of events 12
|
23.4%
15/64 • Number of events 18
|
|
General disorders
Injection site pain
|
6.3%
4/63 • Number of events 5
|
7.8%
5/64 • Number of events 9
|
|
General disorders
Asthenia
|
3.2%
2/63 • Number of events 2
|
6.2%
4/64 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
7/63 • Number of events 10
|
10.9%
7/64 • Number of events 7
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/63 • Number of events 1
|
7.8%
5/64 • Number of events 6
|
|
Infections and infestations
Urinary tract infection
|
4.8%
3/63 • Number of events 4
|
3.1%
2/64 • Number of events 3
|
|
Infections and infestations
Lower respiratory tract infection
|
1.6%
1/63 • Number of events 1
|
4.7%
3/64 • Number of events 3
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
4.8%
3/63 • Number of events 3
|
0.00%
0/64
|
|
Investigations
Weight increased
|
6.3%
4/63 • Number of events 4
|
6.2%
4/64 • Number of events 4
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.6%
1/63 • Number of events 2
|
4.7%
3/64 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
3/63 • Number of events 4
|
6.2%
4/64 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
2/63 • Number of events 2
|
7.8%
5/64 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/63
|
4.7%
3/64 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
11.1%
7/63 • Number of events 11
|
9.4%
6/64 • Number of events 7
|
|
Psychiatric disorders
Insomnia
|
3.2%
2/63 • Number of events 2
|
7.8%
5/64 • Number of events 6
|
|
Psychiatric disorders
Anxiety
|
4.8%
3/63 • Number of events 3
|
1.6%
1/64 • Number of events 2
|
|
Renal and urinary disorders
Nocturia
|
1.6%
1/63 • Number of events 1
|
10.9%
7/64 • Number of events 7
|
|
Renal and urinary disorders
Dysuria
|
4.8%
3/63 • Number of events 3
|
4.7%
3/64 • Number of events 4
|
|
Renal and urinary disorders
Micturition urgency
|
1.6%
1/63 • Number of events 1
|
6.2%
4/64 • Number of events 5
|
|
Renal and urinary disorders
Pollakiuria
|
6.3%
4/63 • Number of events 4
|
1.6%
1/64 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.3%
4/63 • Number of events 4
|
9.4%
6/64 • Number of events 6
|
|
Reproductive system and breast disorders
Gynaecomastia
|
4.8%
3/63 • Number of events 3
|
4.7%
3/64 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
3/63 • Number of events 4
|
4.7%
3/64 • Number of events 3
|
|
Vascular disorders
Hot flush
|
38.1%
24/63 • Number of events 26
|
48.4%
31/64 • Number of events 37
|
|
Vascular disorders
Hypertension
|
6.3%
4/63 • Number of events 4
|
6.2%
4/64 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of ublication 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.
- Publication restrictions are in place
Restriction type: OTHER