Trial Outcomes & Findings for Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer (NCT NCT00819156)
NCT ID: NCT00819156
Last Updated: 2023-11-30
Results Overview
Number of patients who achieved a testosterone level considered a castration level.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
189 participants
Primary outcome timeframe
12 months
Results posted on
2023-11-30
Participant Flow
Two hundred and sixteen patients were screened. Twenty-seven were screening failures. Two randomized patients were not treated: one withdrew consent and the other had an elevated alanine aminotransferase value (an exclusion criteria found after randomization).
Participant milestones
| Measure |
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
32
|
30
|
33
|
31
|
|
Overall Study
Randomised and Treated (ITT Population)
|
30
|
32
|
32
|
30
|
33
|
30
|
|
Overall Study
COMPLETED
|
20
|
23
|
26
|
28
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
6
|
2
|
6
|
8
|
Reasons for withdrawal
| Measure |
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
4
|
2
|
1
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
2
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Testosterone >1ng/ml from Day 28+
|
5
|
2
|
1
|
1
|
1
|
2
|
|
Overall Study
Testosterone >=.5ng/ml 2 visits
|
3
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Prostate-specific antigen progression
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Total
n=187 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
150 Participants
n=8 Participants
|
|
Age, Continuous
|
69.9 years
STANDARD_DEVIATION 8.27 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 7.72 • n=7 Participants
|
73.3 years
STANDARD_DEVIATION 7.39 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 7.07 • n=4 Participants
|
70.7 years
STANDARD_DEVIATION 7.56 • n=21 Participants
|
70.7 years
STANDARD_DEVIATION 8.59 • n=8 Participants
|
70.9 years
STANDARD_DEVIATION 7.75 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
187 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
180 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Number of Patients at Each Stage of Prostate Cancer
Localized
|
8 patients
n=5 Participants
|
6 patients
n=7 Participants
|
6 patients
n=5 Participants
|
5 patients
n=4 Participants
|
11 patients
n=21 Participants
|
5 patients
n=8 Participants
|
41 patients
n=8 Participants
|
|
Number of Patients at Each Stage of Prostate Cancer
Locally advanced
|
8 patients
n=5 Participants
|
11 patients
n=7 Participants
|
11 patients
n=5 Participants
|
12 patients
n=4 Participants
|
8 patients
n=21 Participants
|
10 patients
n=8 Participants
|
60 patients
n=8 Participants
|
|
Number of Patients at Each Stage of Prostate Cancer
Metastatic
|
4 patients
n=5 Participants
|
8 patients
n=7 Participants
|
5 patients
n=5 Participants
|
5 patients
n=4 Participants
|
7 patients
n=21 Participants
|
7 patients
n=8 Participants
|
36 patients
n=8 Participants
|
|
Number of Patients at Each Stage of Prostate Cancer
Not classifiable
|
10 patients
n=5 Participants
|
7 patients
n=7 Participants
|
10 patients
n=5 Participants
|
8 patients
n=4 Participants
|
7 patients
n=21 Participants
|
8 patients
n=8 Participants
|
50 patients
n=8 Participants
|
|
Patient Counts by Gleason Score
unknown
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Patient Counts by Gleason Score
2-4
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
6 participants
n=5 Participants
|
9 participants
n=4 Participants
|
4 participants
n=21 Participants
|
3 participants
n=8 Participants
|
36 participants
n=8 Participants
|
|
Patient Counts by Gleason Score
5-6
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
10 participants
n=4 Participants
|
17 participants
n=21 Participants
|
12 participants
n=8 Participants
|
76 participants
n=8 Participants
|
|
Patient Counts by Gleason Score
7-10
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
11 participants
n=4 Participants
|
12 participants
n=21 Participants
|
15 participants
n=8 Participants
|
73 participants
n=8 Participants
|
|
Body Mass Index
|
26.4 kilograms per square meter
STANDARD_DEVIATION 3.5 • n=5 Participants
|
26.4 kilograms per square meter
STANDARD_DEVIATION 3.74 • n=7 Participants
|
25.9 kilograms per square meter
STANDARD_DEVIATION 4.46 • n=5 Participants
|
27.7 kilograms per square meter
STANDARD_DEVIATION 5.3 • n=4 Participants
|
26 kilograms per square meter
STANDARD_DEVIATION 3.28 • n=21 Participants
|
25.3 kilograms per square meter
STANDARD_DEVIATION 2.73 • n=8 Participants
|
26.3 kilograms per square meter
STANDARD_DEVIATION 3.94 • n=8 Participants
|
|
Days Since Diagnosis of Prostate Cancer
|
493 days
STANDARD_DEVIATION 849 • n=5 Participants
|
122 days
STANDARD_DEVIATION 230 • n=7 Participants
|
375 days
STANDARD_DEVIATION 1098 • n=5 Participants
|
383 days
STANDARD_DEVIATION 817 • n=4 Participants
|
229 days
STANDARD_DEVIATION 508 • n=21 Participants
|
352 days
STANDARD_DEVIATION 743 • n=8 Participants
|
323 days
STANDARD_DEVIATION 756 • n=8 Participants
|
|
Median Serum Testosterone Level
|
4.47 nanogram / milliliter
n=5 Participants
|
3.93 nanogram / milliliter
n=7 Participants
|
4.79 nanogram / milliliter
n=5 Participants
|
4.28 nanogram / milliliter
n=4 Participants
|
4.07 nanogram / milliliter
n=21 Participants
|
3.88 nanogram / milliliter
n=8 Participants
|
4.13 nanogram / milliliter
n=8 Participants
|
|
Serum Prostate-specific Antigen
|
15.2 nanogram / milliliter
n=5 Participants
|
31.5 nanogram / milliliter
n=7 Participants
|
31.5 nanogram / milliliter
n=5 Participants
|
23.1 nanogram / milliliter
n=4 Participants
|
35.3 nanogram / milliliter
n=21 Participants
|
32 nanogram / milliliter
n=8 Participants
|
27.6 nanogram / milliliter
n=8 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: ITT population.
Number of patients who achieved a testosterone level considered a castration level.
Outcome measures
| Measure |
Degarelix 200/80
n=28 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=25 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=27 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=25 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
|
17 participants
Interval 41.0 to 78.0
|
21 participants
Interval 64.0 to 95.0
|
26 participants
Interval 81.0 to 100.0
|
27 participants
Interval 73.0 to 98.0
|
27 participants
Interval 73.0 to 98.0
|
23 participants
Interval 74.0 to 99.0
|
SECONDARY outcome
Timeframe: Day 28 - 364Population: ITT population of patients with testoterone measurements \<=0.5 nanogram/milliliter at Day 28.
Number of patients who maintained a castration level of testosterone (\<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.
Outcome measures
| Measure |
Degarelix 200/80
n=48 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=50 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=49 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28
|
44 participants
Interval 80.0 to 98.0
|
48 participants
Interval 86.0 to 100.0
|
49 participants
Interval 93.0 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: ITT population.
The number of patients who achieved the \<=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
|
21 participants
Interval 51.0 to 85.0
|
29 participants
Interval 75.0 to 98.0
|
31 participants
Interval 84.0 to 100.0
|
29 participants
Interval 83.0 to 100.0
|
31 participants
Interval 80.0 to 99.0
|
27 participants
Interval 77.0 to 99.0
|
SECONDARY outcome
Timeframe: Day 3Population: ITT population.
The number of patients who achieved the \<=0.5 nanogram/milliliter level for serum testosterone after 3 days.
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
|
25 participants
Interval 65.0 to 94.0
|
30 participants
Interval 79.0 to 99.0
|
27 participants
Interval 70.0 to 96.0
|
28 participants
Interval 78.0 to 99.0
|
30 participants
Interval 76.0 to 98.0
|
28 participants
Interval 78.0 to 99.0
|
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 of the baseline value.
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Days to 50 Percent Reduction in Prostate-Specific Antigen
|
14 days
Interval 7.0 to 224.0
|
14 days
Interval 3.0 to 84.0
|
14 days
Interval 3.0 to 42.0
|
14 days
Interval 3.0 to 56.0
|
14 days
Interval 3.0 to 84.0
|
14 days
Interval 3.0 to 56.0
|
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 90 percent of the baseline value.
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Days to 90 Percent Reduction in Prostate-Specific Antigen
|
56 days
Interval 28.0 to 168.0
|
56 days
Interval 14.0 to 336.0
|
56 days
Interval 14.0 to 336.0
|
56 days
Interval 14.0 to 196.0
|
56 days
Interval 28.0 to 364.0
|
56 days
Interval 14.0 to 196.0
|
SECONDARY outcome
Timeframe: Day 0 (post dose) to Day 364Population: Number of patients with PSA progression in the six groups n=0,3,1,4,4,2. Since no patients in the 200/80 group experience PSA progression the Days to progression could not be calculated.
Median days to prostate-specific antigen increase of \>= 50 percent and \>=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.
Outcome measures
| Measure |
Degarelix 200/80
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Days to Prostate-Specific Antigen Progression
|
224 days
Interval 140.0 to 308.0
|
308 days
Interval 308.0 to 308.0
|
280 days
Interval 252.0 to 336.0
|
224 days
Interval 126.0 to 364.0
|
140 days
Interval 140.0 to 140.0
|
—
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Days 1,3,7,14, and 364Population: ITT population
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Median Serum Testosterone Levels
Day 0 (Baseline)
|
4.47 nanogram/milliliter
Interval 0.816 to 7.1
|
3.93 nanogram/milliliter
Interval 1.53 to 9.29
|
4.79 nanogram/milliliter
Interval 2.8 to 9.47
|
4.28 nanogram/milliliter
Interval 1.4 to 10.2
|
4.07 nanogram/milliliter
Interval 2.02 to 7.7
|
3.88 nanogram/milliliter
Interval 1.69 to 8.63
|
|
Median Serum Testosterone Levels
Day 1 (n=30,32,32,30,33,30)
|
0.654 nanogram/milliliter
Interval 0.167 to 1.81
|
0.436 nanogram/milliliter
Interval 0.207 to 1.21
|
0.465 nanogram/milliliter
Interval 0.287 to 2.44
|
0.563 nanogram/milliliter
Interval 0.2 to 3.0
|
0.453 nanogram/milliliter
Interval 0.21 to 3.32
|
0.576 nanogram/milliliter
Interval 0.261 to 1.36
|
|
Median Serum Testosterone Levels
Day 3 (n=30,32,31,30,33,30)
|
0.308 nanogram/milliliter
Interval 0.121 to 2.81
|
0.26 nanogram/milliliter
Interval 0.139 to 0.657
|
0.281 nanogram/milliliter
Interval 0.125 to 0.64
|
0.265 nanogram/milliliter
Interval 0.119 to 0.586
|
0.268 nanogram/milliliter
Interval 0.133 to 0.912
|
0.261 nanogram/milliliter
Interval 0.144 to 1.3
|
|
Median Serum Testosterone Levels
Day 7 (n=30,32,32,30,33,28)
|
0.283 nanogram/milliliter
Interval 0.098 to 4.0
|
0.237 nanogram/milliliter
Interval 0.066 to 1.43
|
0.198 nanogram/milliliter
Interval 0.087 to 0.808
|
0.193 nanogram/milliliter
Interval 0.104 to 0.549
|
0.216 nanogram/milliliter
Interval 0.116 to 1.55
|
0.207 nanogram/milliliter
Interval 0.074 to 4.66
|
|
Median Serum Testosterone Levels
Day 14 (n=30,32,32,30,33,29)
|
0.173 nanogram/milliliter
Interval 0.025 to 4.77
|
0.144 nanogram/milliliter
Interval 0.054 to 1.62
|
0.122 nanogram/milliliter
Interval 0.025 to 0.617
|
0.152 nanogram/milliliter
Interval 0.025 to 0.641
|
0.134 nanogram/milliliter
Interval 0.05 to 0.924
|
0.126 nanogram/milliliter
Interval 0.055 to 2.67
|
|
Median Serum Testosterone Levels
Day 364 (n=20,23,26,28,27,23)
|
0.137 nanogram/milliliter
Interval 0.025 to 1.31
|
0.124 nanogram/milliliter
Interval 0.025 to 0.53
|
0.105 nanogram/milliliter
Interval 0.025 to 0.221
|
0.126 nanogram/milliliter
Interval 0.025 to 1.31
|
0.12 nanogram/milliliter
Interval 0.025 to 0.287
|
0.124 nanogram/milliliter
Interval 0.05 to 0.371
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Days 3, 7, 14, and 364Population: ITT population
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Median Prostate-specific Antigen Levels
Day 0 (Baseline)
|
15.2 nanogram / milliliter
Interval 2.6 to 332.0
|
31.5 nanogram / milliliter
Interval 3.3 to 1730.0
|
31.5 nanogram / milliliter
Interval 2.6 to 901.0
|
23.1 nanogram / milliliter
Interval 3.6 to 586.0
|
35.3 nanogram / milliliter
Interval 2.4 to 1110.0
|
32 nanogram / milliliter
Interval 2.0 to 1297.0
|
|
Median Prostate-specific Antigen Levels
Day 3 (n=29,30,28,29,33,28)
|
13.7 nanogram / milliliter
Interval 2.4 to 207.0
|
29.9 nanogram / milliliter
Interval 3.0 to 1061.0
|
27.8 nanogram / milliliter
Interval 2.0 to 443.0
|
22.2 nanogram / milliliter
Interval 2.7 to 503.0
|
26.3 nanogram / milliliter
Interval 1.8 to 928.0
|
25.2 nanogram / milliliter
Interval 1.3 to 945.0
|
|
Median Prostate-specific Antigen Levels
Day 7 (n=30,32,32,30,33,28)
|
10.6 nanogram / milliliter
Interval 1.9 to 138.0
|
18.5 nanogram / milliliter
Interval 2.4 to 420.0
|
16.5 nanogram / milliliter
Interval 1.8 to 234.0
|
14.8 nanogram / milliliter
Interval 2.4 to 339.0
|
20.8 nanogram / milliliter
Interval 1.5 to 611.0
|
16.9 nanogram / milliliter
Interval 0.9 to 476.0
|
|
Median Prostate-specific Antigen Levels
Day 14 (n=29,31,32,29,33,28)
|
7.9 nanogram / milliliter
Interval 1.0 to 69.5
|
10.9 nanogram / milliliter
Interval 1.8 to 155.0
|
9.9 nanogram / milliliter
Interval 1.3 to 142.0
|
7.1 nanogram / milliliter
Interval 1.4 to 213.0
|
13.4 nanogram / milliliter
Interval 0.4 to 490.0
|
8.35 nanogram / milliliter
Interval 0.4 to 163.0
|
|
Median Prostate-specific Antigen Levels
Day 364 (n=20,23,26,28,27,22)
|
0.45 nanogram / milliliter
Interval 0.1 to 5.5
|
0.6 nanogram / milliliter
Interval 0.1 to 21.2
|
0.95 nanogram / milliliter
Interval 0.1 to 21.6
|
0.9 nanogram / milliliter
Interval 0.1 to 135.0
|
0.8 nanogram / milliliter
Interval 0.1 to 48.6
|
0.3 nanogram / milliliter
Interval 0.1 to 9.4
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Days 1, 3, 7, 14, and 364Population: ITT population
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Median Values of Di-Hydrotestosterone
Day 0 (Baseline; n=25,30,26,23,23,25)
|
430 picogram / milliliter
Interval 140.0 to 2600.0
|
330 picogram / milliliter
Interval 94.0 to 760.0
|
310 picogram / milliliter
Interval 170.0 to 630.0
|
330 picogram / milliliter
Interval 20.0 to 760.0
|
350 picogram / milliliter
Interval 160.0 to 640.0
|
290 picogram / milliliter
Interval 160.0 to 550.0
|
|
Median Values of Di-Hydrotestosterone
Day 1 (n=23,27,25,24,26,24)
|
130 picogram / milliliter
Interval 41.0 to 320.0
|
95 picogram / milliliter
Interval 54.0 to 290.0
|
110 picogram / milliliter
Interval 44.0 to 250.0
|
130 picogram / milliliter
Interval 30.0 to 380.0
|
110 picogram / milliliter
Interval 60.0 to 480.0
|
115 picogram / milliliter
Interval 49.0 to 220.0
|
|
Median Values of Di-Hydrotestosterone
Day 3 (n=23,27,25,25,27,25)
|
82 picogram / milliliter
Interval 22.0 to 150.0
|
67 picogram / milliliter
Interval 32.0 to 130.0
|
70 picogram / milliliter
Interval 22.0 to 130.0
|
66 picogram / milliliter
Interval 25.0 to 180.0
|
73 picogram / milliliter
Interval 10.0 to 190.0
|
67 picogram / milliliter
Interval 10.0 to 180.0
|
|
Median Values of Di-Hydrotestosterone
Day 7 (n=26,30,24,26,30,22)
|
63 picogram / milliliter
Interval 10.0 to 260.0
|
65 picogram / milliliter
Interval 31.0 to 220.0
|
61.5 picogram / milliliter
Interval 22.0 to 150.0
|
56.5 picogram / milliliter
Interval 21.0 to 130.0
|
61 picogram / milliliter
Interval 20.0 to 240.0
|
77.5 picogram / milliliter
Interval 20.0 to 240.0
|
|
Median Values of Di-Hydrotestosterone
Day 14 (n=19,27,25,23,25,27)
|
68 picogram / milliliter
Interval 10.0 to 440.0
|
51 picogram / milliliter
Interval 22.0 to 120.0
|
42 picogram / milliliter
Interval 10.0 to 110.0
|
57 picogram / milliliter
Interval 10.0 to 110.0
|
59 picogram / milliliter
Interval 10.0 to 130.0
|
53 picogram / milliliter
Interval 32.0 to 250.0
|
|
Median Values of Di-Hydrotestosterone
Day 364 (n=17,21,20,25,25,21)
|
41 picogram / milliliter
Interval 10.0 to 79.0
|
39 picogram / milliliter
Interval 10.0 to 73.0
|
34 picogram / milliliter
Interval 10.0 to 72.0
|
40 picogram / milliliter
Interval 10.0 to 120.0
|
39 picogram / milliliter
Interval 10.0 to 210.0
|
40 picogram / milliliter
Interval 10.0 to 130.0
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Days 1, 3, 7, 14, and 364Population: ITT population
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Median Values for Serum Luteinizing Hormone
Day 0 (Baseline)
|
3.8 international units / liter
Interval 0.5 to 9.6
|
4 international units / liter
Interval 1.6 to 15.0
|
5.05 international units / liter
Interval 1.2 to 27.6
|
5.6 international units / liter
Interval 1.0 to 18.0
|
3.9 international units / liter
Interval 1.6 to 25.9
|
6 international units / liter
Interval 1.6 to 19.5
|
|
Median Values for Serum Luteinizing Hormone
Day 1 (n=28,30,32,28,31,30)
|
0.8 international units / liter
Interval 0.05 to 5.7
|
0.65 international units / liter
Interval 0.3 to 3.4
|
0.7 international units / liter
Interval 0.2 to 4.6
|
0.9 international units / liter
Interval 0.2 to 5.8
|
0.7 international units / liter
Interval 0.3 to 7.2
|
0.75 international units / liter
Interval 0.4 to 4.6
|
|
Median Values for Serum Luteinizing Hormone
Day 3 (n=29,30,28,29,33,28)
|
0.5 international units / liter
Interval 0.1 to 2.7
|
0.5 international units / liter
Interval 0.2 to 1.9
|
0.5 international units / liter
Interval 0.2 to 2.1
|
0.5 international units / liter
Interval 0.2 to 1.3
|
0.4 international units / liter
Interval 0.2 to 2.4
|
0.55 international units / liter
Interval 0.2 to 1.8
|
|
Median Values for Serum Luteinizing Hormone
Day 7 (n=30,32,32,30,33,28)
|
0.7 international units / liter
Interval 0.05 to 5.7
|
0.5 international units / liter
Interval 0.2 to 2.5
|
0.6 international units / liter
Interval 0.2 to 3.4
|
0.5 international units / liter
Interval 0.05 to 3.4
|
0.5 international units / liter
Interval 0.2 to 2.5
|
0.75 international units / liter
Interval 0.2 to 4.3
|
|
Median Values for Serum Luteinizing Hormone
Day 14 (n=29,31,32,29,33,28)
|
0.5 international units / liter
Interval 0.05 to 7.4
|
0.3 international units / liter
Interval 0.1 to 2.8
|
0.35 international units / liter
Interval 0.05 to 4.5
|
0.3 international units / liter
Interval 0.05 to 5.1
|
0.3 international units / liter
Interval 0.05 to 1.8
|
0.3 international units / liter
Interval 0.05 to 4.8
|
|
Median Values for Serum Luteinizing Hormone
Day 364 (n=20,23,26,28,27,22)
|
0.3 international units / liter
Interval 0.05 to 1.5
|
0.3 international units / liter
Interval 0.05 to 2.3
|
0.2 international units / liter
Interval 0.05 to 0.6
|
0.4 international units / liter
Interval 0.05 to 2.5
|
0.2 international units / liter
Interval 0.05 to 0.8
|
0.3 international units / liter
Interval 0.05 to 1.3
|
SECONDARY outcome
Timeframe: Day 0 (Baseline), Days 1, 3, 7, 14, and 364Population: ITT population
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Median Values for Follicle Stimulation Hormone
Day 0 (Baseline)
|
8.35 international units / liter
Interval 2.3 to 45.4
|
9.25 international units / liter
Interval 2.4 to 39.2
|
9 international units / liter
Interval 3.8 to 40.7
|
9.7 international units / liter
Interval 4.1 to 61.7
|
7 international units / liter
Interval 2.3 to 76.1
|
10.2 international units / liter
Interval 1.8 to 67.9
|
|
Median Values for Follicle Stimulation Hormone
Day 1 (n=28,30,32,28,31,30)
|
5.15 international units / liter
Interval 1.4 to 28.6
|
5.65 international units / liter
Interval 1.5 to 24.8
|
5.35 international units / liter
Interval 2.3 to 24.8
|
6.2 international units / liter
Interval 2.4 to 46.2
|
4.4 international units / liter
Interval 1.7 to 55.2
|
5.9 international units / liter
Interval 1.0 to 47.4
|
|
Median Values for Follicle Stimulation Hormone
Day 3 (n=29,30,28,29,33,28)
|
2.9 international units / liter
Interval 0.8 to 14.4
|
3.15 international units / liter
Interval 1.0 to 14.1
|
3.25 international units / liter
Interval 1.2 to 13.5
|
3.3 international units / liter
Interval 1.4 to 9.3
|
2.5 international units / liter
Interval 0.9 to 31.5
|
3.1 international units / liter
Interval 0.7 to 24.1
|
|
Median Values for Follicle Stimulation Hormone
Day 7 (n=30,32,32,30,33,28)
|
2.7 international units / liter
Interval 0.3 to 9.3
|
1.95 international units / liter
Interval 0.6 to 12.9
|
1.85 international units / liter
Interval 0.8 to 8.7
|
1.85 international units / liter
Interval 0.7 to 16.0
|
1.4 international units / liter
Interval 0.5 to 16.1
|
2.55 international units / liter
Interval 0.6 to 13.1
|
|
Median Values for Follicle Stimulation Hormone
Day 14 (n=29,31,32,29,33,28)
|
1.6 international units / liter
Interval 0.05 to 11.5
|
1.1 international units / liter
Interval 0.3 to 11.2
|
0.9 international units / liter
Interval 0.2 to 7.9
|
0.8 international units / liter
Interval 0.2 to 8.5
|
0.7 international units / liter
Interval 0.1 to 8.0
|
0.95 international units / liter
Interval 0.2 to 14.5
|
|
Median Values for Follicle Stimulation Hormone
Day 364 (n=20,23,26,28,27,22)
|
1.8 international units / liter
Interval 0.2 to 7.0
|
1.5 international units / liter
Interval 0.2 to 7.6
|
1.45 international units / liter
Interval 0.2 to 6.4
|
1.75 international units / liter
Interval 0.1 to 13.0
|
1.1 international units / liter
Interval 0.3 to 5.3
|
2.2 international units / liter
Interval 0.3 to 11.4
|
SECONDARY outcome
Timeframe: 364 daysPopulation: ITT population
The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases \>3x ULN, and patients with ALT increases \>3x ULN with concurrent increases in bilirubin \>1.5 ULN.
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
The Number of Patients With Abnormal Liver Function Tests
Abnormal alanine aminotransferase (ALT)
|
6 participants
|
10 participants
|
15 participants
|
13 participants
|
8 participants
|
9 participants
|
|
The Number of Patients With Abnormal Liver Function Tests
Abnormal aspartate aminotransferase
|
7 participants
|
10 participants
|
15 participants
|
8 participants
|
13 participants
|
13 participants
|
|
The Number of Patients With Abnormal Liver Function Tests
Abnormal bilirubin
|
2 participants
|
5 participants
|
1 participants
|
2 participants
|
5 participants
|
1 participants
|
|
The Number of Patients With Abnormal Liver Function Tests
ALT >3x ULN
|
3 participants
|
8 participants
|
12 participants
|
13 participants
|
7 participants
|
8 participants
|
|
The Number of Patients With Abnormal Liver Function Tests
ALT>3x ULN and bilirubin >1.5x ULN
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 364Population: ITT population
Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.
Outcome measures
| Measure |
Degarelix 200/80
n=30 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
n=32 Participants
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
n=33 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
n=30 Participants
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Diastolic blood pressure <=50 and decrease >=15
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
2 participants
|
|
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Diastolic blood pressure >=105 and increase >=15
|
3 participants
|
3 participants
|
4 participants
|
3 participants
|
0 participants
|
2 participants
|
|
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Pulse <=50 and decrease >=15 from baseline
|
0 participants
|
2 participants
|
0 participants
|
2 participants
|
1 participants
|
1 participants
|
|
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Pulse >=120 and increase of >=15 from baseline
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Systolic blood pressure <=90 and decrease >=20
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Systolic blood pressure >=180 and increase >=20
|
3 participants
|
2 participants
|
4 participants
|
0 participants
|
3 participants
|
2 participants
|
|
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Weight decrease of >=7% from baseline
|
0 participants
|
1 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
|
The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Weight increase of >=7% from baseline
|
3 participants
|
4 participants
|
6 participants
|
5 participants
|
4 participants
|
1 participants
|
Adverse Events
Degarelix 200/80
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Degarelix 200/120
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Degarelix 200/160
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Degarelix 240/80
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Degarelix 240/120
Serious events: 6 serious events
Other events: 23 other events
Deaths: 0 deaths
Degarelix 240/160
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
0.00%
0/30
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
0.00%
0/30
|
|
Eye disorders
Corneal defect
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
General disorders
Disease progression
|
3.3%
1/30 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Investigations
Alanine aminotransferase increased
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Investigations
Blood alkaline phosphatase increased
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 2
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to penis
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
6.1%
2/33 • Number of events 2
|
0.00%
0/30
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Psychiatric disorders
Depression
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
0.00%
0/30
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Renal and urinary disorders
Hydronephrosis
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
0.00%
0/30
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
0.00%
0/30
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Renal and urinary disorders
Haematuria
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 2
|
Other adverse events
| Measure |
Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
|
Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
6.7%
2/30 • Number of events 2
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
6.7%
2/30 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
1/30 • Number of events 2
|
9.4%
3/32 • Number of events 4
|
6.7%
2/30 • Number of events 2
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
6.7%
2/30 • Number of events 2
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Injection site pain
|
3.3%
1/30 • Number of events 1
|
9.4%
3/32 • Number of events 3
|
18.8%
6/32 • Number of events 17
|
0.00%
0/30
|
18.2%
6/33 • Number of events 11
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 3
|
10.0%
3/30 • Number of events 4
|
3.0%
1/33 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
|
General disorders
Injection site swelling
|
0.00%
0/30
|
6.2%
2/32 • Number of events 4
|
6.2%
2/32 • Number of events 7
|
0.00%
0/30
|
3.0%
1/33 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Number of events 4
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
6.7%
2/30 • Number of events 5
|
|
General disorders
Injection site erythema
|
0.00%
0/30
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
6.1%
2/33 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
General disorders
Injection site inflammation
|
0.00%
0/30
|
6.2%
2/32 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Infections and infestations
Urinary tract infection
|
6.7%
2/30 • Number of events 2
|
6.2%
2/32 • Number of events 2
|
6.2%
2/32 • Number of events 4
|
6.7%
2/30 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Influenza
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
2/30 • Number of events 3
|
0.00%
0/32
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
6.7%
2/30 • Number of events 2
|
|
Infections and infestations
Bronchitis
|
0.00%
0/30
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Weight increase
|
3.3%
1/30 • Number of events 1
|
9.4%
3/32 • Number of events 3
|
12.5%
4/32 • Number of events 4
|
13.3%
4/30 • Number of events 4
|
9.1%
3/33 • Number of events 3
|
6.7%
2/30 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
9.4%
3/32 • Number of events 4
|
0.00%
0/30
|
3.0%
1/33 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
2/30 • Number of events 2
|
0.00%
0/32
|
6.2%
2/32 • Number of events 3
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
0.00%
0/30
|
3.0%
1/33 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
|
Investigations
Blood urea increased
|
0.00%
0/30
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
6.7%
2/30 • Number of events 3
|
0.00%
0/33
|
0.00%
0/32
|
|
Investigations
Blood creatinine increased
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
6.7%
2/30 • Number of events 2
|
0.00%
0/33
|
0.00%
0/30
|
|
Investigations
Weight decreased
|
0.00%
0/30
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1
|
9.4%
3/32 • Number of events 3
|
3.1%
1/32 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 2
|
0.00%
0/32
|
6.2%
2/32 • Number of events 3
|
0.00%
0/30
|
0.00%
0/33
|
6.7%
2/30 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30
|
3.1%
1/32 • Number of events 1
|
3.1%
1/32 • Number of events 2
|
6.7%
2/30 • Number of events 3
|
6.1%
2/33 • Number of events 2
|
0.00%
0/30
|
|
Nervous system disorders
Headache
|
0.00%
0/30
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
6.7%
2/30 • Number of events 2
|
0.00%
0/33
|
6.7%
2/30 • Number of events 3
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
6.7%
2/30 • Number of events 2
|
0.00%
0/33
|
0.00%
0/30
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1
|
3.1%
1/32 • Number of events 1
|
9.4%
3/32 • Number of events 3
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/30
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
0.00%
0/30
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/30
|
0.00%
0/32
|
0.00%
0/32
|
6.7%
2/30 • Number of events 2
|
0.00%
0/33
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.7%
2/30 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 2
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Reproductive system and breast disorders
Testicular atrophy
|
6.7%
2/30 • Number of events 2
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Reproductive system and breast disorders
Gynaecomastia
|
6.7%
2/30 • Number of events 2
|
0.00%
0/32
|
0.00%
0/32
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
0.00%
0/30
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
2/30 • Number of events 2
|
3.1%
1/32 • Number of events 1
|
6.2%
2/32 • Number of events 3
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
10.0%
3/30 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/30
|
6.2%
2/32 • Number of events 3
|
0.00%
0/32
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • Number of events 2
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
0.00%
0/30
|
0.00%
0/33
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/30
|
0.00%
0/32
|
3.1%
1/32 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
9.1%
3/33 • Number of events 3
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.3%
1/30 • Number of events 1
|
0.00%
0/32
|
6.2%
2/32 • Number of events 2
|
3.3%
1/30 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • Number of events 2
|
0.00%
0/32
|
0.00%
0/32
|
0.00%
0/30
|
0.00%
0/33
|
3.3%
1/30 • Number of events 1
|
|
Vascular disorders
Hot flush
|
46.7%
14/30 • Number of events 16
|
25.0%
8/32 • Number of events 8
|
31.2%
10/32 • Number of events 13
|
36.7%
11/30 • Number of events 14
|
27.3%
9/33 • Number of events 9
|
33.3%
10/30 • Number of events 10
|
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 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.
- Publication restrictions are in place
Restriction type: OTHER