Prostate Cancer
Conditions
Keywords
Prostate Cancer, Androgen ablation therapy
Brief summary
The purpose of the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.
Interventions
DRUGDegarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet the following inclusion criteria before entry into the study. * Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient). * Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention. * Male patient aged 18 years or over. * Has a baseline testosterone above the lower limit of normal range. * Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2. * Has a PSA value of greater than or equal to 2ng/mL.
Exclusion criteria
Any patient meeting one or more of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364 | Day 28 to Day 364 | Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364 |
| 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 | Day 28 - Day 364 | Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen | Day 0 (post dose) to Day 364 | 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. |
| Days to Prostate-Specific Antigen Progression | Day 0 (post dose) to Day 364 | 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. |
| Median Di-Hydrotestosterone Levels At Various Study Timepoints | Baseline, Days 1, 3, 7, 14 | Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14 |
| Median Prostate-Specific Antigen Values at Various Study Timepoints | Baseline, Days 3, 14, 28, 84, 364 | Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364. |
| Median Luteinizing Hormone Levels at Various Study Timeframes | Baseline, Days 1, 3, 7, 14 | Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14. |
| Number of Participants With Abnormal Alanine Aminotransferase Values | Day 1 through day 364 | Participants whose alanine aminotransferase values were at levels above the normal range. |
| Number of Participants With Abnormal Aspartate Aminotransferase Values | Day 1 - 364 | Participants with aspartate aminotransferase values that were above the normal range. |
| Number of Participants With Abnormal Total Bilirubin Values | Day 1 - 364 | Participants with abnormal total bilirubin values |
| Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Day 364 | 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. |
| Median Testosterone Levels at Various Days During the Study | Baseline, Days 1,3,7,14,364 | Testosterone levels at baseline and days 1, 3, 7, 14 and 364 |
| Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3. | Day 3 | Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing. |
Countries
Canada, United States
Participant flow
Pre-assignment details
One hundred and seventy-six patients were screened to identify the one hundred and twenty-seven patients who were eligible for randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 63 |
| 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. | 64 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Elevated PSA levels | 2 | 2 |
| Overall Study | Inadequate testosterone suppression | 7 | 9 |
| Overall Study | Physician Decision | 3 | 1 |
| Overall Study | Protocol Violation | 1 | 4 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Degarelix 60mg | Degarelix 80mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 54 Participants | 55 Participants | 109 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Age Continuous | 74.8 years STANDARD_DEVIATION 8.73 | 74.9 years STANDARD_DEVIATION 9.55 | 74.9 years STANDARD_DEVIATION 9.12 |
| Body Mass Index | 27.3 kilogram per square meter FULL_RANGE 4.1 | 26.7 kilogram per square meter FULL_RANGE 3.98 | 27 kilogram per square meter FULL_RANGE 4.03 |
| Curative Intent No | 41 participants | 40 participants | 81 participants |
| Curative Intent Yes | 22 participants | 24 participants | 46 participants |
| Days Since Diagnosis of Prostate Cancer | 1213 days STANDARD_DEVIATION 1597 | 1256 days STANDARD_DEVIATION 1550 | 1234 days STANDARD_DEVIATION 1568 |
| Participant Counts by Gleason Score 2-4 | 3 participants | 3 participants | 6 participants |
| Participant Counts by Gleason Score 5-6 | 19 participants | 22 participants | 41 participants |
| Participant Counts by Gleason Score 7-10 | 41 participants | 39 participants | 80 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 4 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 59 Participants | 107 Participants |
| Serum Prostate-Specific Antigen | 12.7 nanograms/milliliter | 13.7 nanograms/milliliter | 13.4 nanograms/milliliter |
| Serum Testosterone level | 4.1 nanograms/milliliter | 4.23 nanograms/milliliter | 4.13 nanograms/milliliter |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 63 Participants | 64 Participants | 127 Participants |
| The Number of Participants at Each Stage of Prostate Cancer Localized | 31 participants | 23 participants | 54 participants |
| The Number of Participants at Each Stage of Prostate Cancer Locally advanced | 5 participants | 9 participants | 14 participants |
| The Number of Participants at Each Stage of Prostate Cancer Metastatic | 15 participants | 9 participants | 24 participants |
| The Number of Participants at Each Stage of Prostate Cancer Not classifiable | 12 participants | 23 participants | 35 participants |
| Weight | 83 Kilograms STANDARD_DEVIATION 14.6 | 81.2 Kilograms STANDARD_DEVIATION 12.7 | 82.1 Kilograms STANDARD_DEVIATION 13.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 55 / — | 52 / — |
| serious Total, serious adverse events | 9 / — | 6 / — |
Outcome results
Primary
Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
Number of participants with all testosterone values \<=0.5 nanogram/milliliter from Day 28 to Day 364
Time frame: Day 28 to Day 364
Population: ITT population of patients who completed the study and had testosterone \<=0.5 nanogram per milliliter at Day 28.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 60mg | Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364 | 42 participants |
| Degarelix 80mg | Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364 | 41 participants |
95% CI: [73, 94]
95% CI: [64, 88]
Primary
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
Number of participants who maintained a testosterone level of \<=0.5 nanogram/milliliter from Day 28 to Day 364.
Time frame: Day 28 - Day 364
Population: ITT population of participants who completed the study and had a testosterone level of \<=0.5 nanogram per milliliter at Day 28.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 60mg | 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 |
| Degarelix 80mg | 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 | 41 participants |
95% CI: [82, 99]
95% CI: [87, 100]
Secondary
Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
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.
Time frame: Day 0 (post dose) to Day 364
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 60mg | Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen | 50 percent reduction (n=59, 59) | 14 days |
| Degarelix 60mg | Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen | 90 percent reduction (n=45, 48) | 56 days |
| Degarelix 80mg | Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen | 50 percent reduction (n=59, 59) | 14 days |
| Degarelix 80mg | Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen | 90 percent reduction (n=45, 48) | 56 days |
Comparison: Time to 50% reductionp-value: 0.904Log Rank
Comparison: Days to 90% reductionp-value: 0.778Log Rank
Secondary
Days to Prostate-Specific Antigen 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.
Time frame: Day 0 (post dose) to Day 364
Population: ITT population. 5 patients in the 60 mg group and 4 patients in the 80 mg group had PSA progression.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 60mg | Days to Prostate-Specific Antigen Progression | 196 days |
| Degarelix 80mg | Days to Prostate-Specific Antigen Progression | 154 days |
Secondary
Median Di-Hydrotestosterone Levels At Various Study Timepoints
Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14
Time frame: Baseline, Days 1, 3, 7, 14
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 60mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Day 1 (n=62, 62) | 110 picogram / milliliter |
| Degarelix 60mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Day 7 (n=58, 63) | 45.5 picogram / milliliter |
| Degarelix 60mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Day 3 (n=58, 63) | 56.5 picogram / milliliter |
| Degarelix 60mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Day 14 (n=61, 61) | 37 picogram / milliliter |
| Degarelix 60mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Baseline (n=63, 64) | 360 picogram / milliliter |
| Degarelix 80mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Day 14 (n=61, 61) | 40 picogram / milliliter |
| Degarelix 80mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Baseline (n=63, 64) | 350 picogram / milliliter |
| Degarelix 80mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Day 1 (n=62, 62) | 120 picogram / milliliter |
| Degarelix 80mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Day 3 (n=58, 63) | 57 picogram / milliliter |
| Degarelix 80mg | Median Di-Hydrotestosterone Levels At Various Study Timepoints | Day 7 (n=58, 63) | 52 picogram / milliliter |
Secondary
Median Luteinizing Hormone Levels at Various Study Timeframes
Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.
Time frame: Baseline, Days 1, 3, 7, 14
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 60mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Day 1 (n=58, 61) | 0.915 international units / liter |
| Degarelix 60mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Day 7 (n=60, 61) | 0.41 international units / liter |
| Degarelix 60mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Day 3 (n=59, 60) | 0.43 international units / liter |
| Degarelix 60mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Day 14 (n=61, 62) | 0.2 international units / liter |
| Degarelix 60mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Baseline (n=63, 64) | 5.28 international units / liter |
| Degarelix 80mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Day 14 (n=61, 62) | 0.37 international units / liter |
| Degarelix 80mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Baseline (n=63, 64) | 5.33 international units / liter |
| Degarelix 80mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Day 1 (n=58, 61) | 0.87 international units / liter |
| Degarelix 80mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Day 3 (n=59, 60) | 0.425 international units / liter |
| Degarelix 80mg | Median Luteinizing Hormone Levels at Various Study Timeframes | Day 7 (n=60, 61) | 0.6 international units / liter |
Secondary
Median Prostate-Specific Antigen Values at Various Study Timepoints
Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.
Time frame: Baseline, Days 3, 14, 28, 84, 364
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 60mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Baseline (n=63, 64) | 12.7 nanogram / milliliter |
| Degarelix 60mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 3 (n=60, 64) | 11.4 nanogram / milliliter |
| Degarelix 60mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 14 (n=61, 63) | 6.4 nanogram / milliliter |
| Degarelix 60mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 28 (n=61, 63) | 2.9 nanogram / milliliter |
| Degarelix 60mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 84 (n=57, 54) | 0.8 nanogram / milliliter |
| Degarelix 60mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 364 (n=42, 43) | 0.4 nanogram / milliliter |
| Degarelix 80mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 84 (n=57, 54) | 0.7 nanogram / milliliter |
| Degarelix 80mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Baseline (n=63, 64) | 13.7 nanogram / milliliter |
| Degarelix 80mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 28 (n=61, 63) | 3.6 nanogram / milliliter |
| Degarelix 80mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 3 (n=60, 64) | 12.2 nanogram / milliliter |
| Degarelix 80mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 364 (n=42, 43) | 0.2 nanogram / milliliter |
| Degarelix 80mg | Median Prostate-Specific Antigen Values at Various Study Timepoints | Day 14 (n=61, 63) | 6.8 nanogram / milliliter |
Secondary
Median Testosterone Levels at Various Days During the Study
Testosterone levels at baseline and days 1, 3, 7, 14 and 364
Time frame: Baseline, Days 1,3,7,14,364
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 60mg | Median Testosterone Levels at Various Days During the Study | Day 1 (n=61, 63) | 0.56 nanograms / milliliter |
| Degarelix 60mg | Median Testosterone Levels at Various Days During the Study | Day 7 (n=60, 64) | 0.18 nanograms / milliliter |
| Degarelix 60mg | Median Testosterone Levels at Various Days During the Study | Baseline (n=63, 64) | 4.1 nanograms / milliliter |
| Degarelix 60mg | Median Testosterone Levels at Various Days During the Study | Day 3 (n=60, 63) | 0.26 nanograms / milliliter |
| Degarelix 60mg | Median Testosterone Levels at Various Days During the Study | Day 364 (n=42, 43) | 0.07 nanograms / milliliter |
| Degarelix 60mg | Median Testosterone Levels at Various Days During the Study | Day 14 (n=61, 63) | 0.11 nanograms / milliliter |
| Degarelix 80mg | Median Testosterone Levels at Various Days During the Study | Day 364 (n=42, 43) | 0.07 nanograms / milliliter |
| Degarelix 80mg | Median Testosterone Levels at Various Days During the Study | Baseline (n=63, 64) | 4.23 nanograms / milliliter |
| Degarelix 80mg | Median Testosterone Levels at Various Days During the Study | Day 1 (n=61, 63) | 0.71 nanograms / milliliter |
| Degarelix 80mg | Median Testosterone Levels at Various Days During the Study | Day 3 (n=60, 63) | 0.31 nanograms / milliliter |
| Degarelix 80mg | Median Testosterone Levels at Various Days During the Study | Day 7 (n=60, 64) | 0.24 nanograms / milliliter |
| Degarelix 80mg | Median Testosterone Levels at Various Days During the Study | Day 14 (n=61, 63) | 0.14 nanograms / milliliter |
Secondary
Number of Participants With Abnormal Alanine Aminotransferase Values
Participants whose alanine aminotransferase values were at levels above the normal range.
Time frame: Day 1 through day 364
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 60mg | Number of Participants With Abnormal Alanine Aminotransferase Values | > upper limit and 3 times upper limit | 10 participants |
| Degarelix 60mg | Number of Participants With Abnormal Alanine Aminotransferase Values | Total abnormal (> upper limit) | 10 participants |
| Degarelix 60mg | Number of Participants With Abnormal Alanine Aminotransferase Values | Total normal (<=upper limit) | 52 participants |
| Degarelix 80mg | Number of Participants With Abnormal Alanine Aminotransferase Values | > upper limit and 3 times upper limit | 21 participants |
| Degarelix 80mg | Number of Participants With Abnormal Alanine Aminotransferase Values | Total abnormal (> upper limit) | 21 participants |
| Degarelix 80mg | Number of Participants With Abnormal Alanine Aminotransferase Values | Total normal (<=upper limit) | 43 participants |
Secondary
Number of Participants With Abnormal Aspartate Aminotransferase Values
Participants with aspartate aminotransferase values that were above the normal range.
Time frame: Day 1 - 364
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 60mg | Number of Participants With Abnormal Aspartate Aminotransferase Values | > 3 times upper limit - 5 times upper limit | 0 participants |
| Degarelix 60mg | Number of Participants With Abnormal Aspartate Aminotransferase Values | > upper limit - 3 times upper limit | 6 participants |
| Degarelix 60mg | Number of Participants With Abnormal Aspartate Aminotransferase Values | Total Abnormal (> upper limit) | 6 participants |
| Degarelix 60mg | Number of Participants With Abnormal Aspartate Aminotransferase Values | Total Normal (<= upper limit) | 56 participants |
| Degarelix 80mg | Number of Participants With Abnormal Aspartate Aminotransferase Values | Total Normal (<= upper limit) | 58 participants |
| Degarelix 80mg | Number of Participants With Abnormal Aspartate Aminotransferase Values | > 3 times upper limit - 5 times upper limit | 1 participants |
| Degarelix 80mg | Number of Participants With Abnormal Aspartate Aminotransferase Values | Total Abnormal (> upper limit) | 6 participants |
| Degarelix 80mg | Number of Participants With Abnormal Aspartate Aminotransferase Values | > upper limit - 3 times upper limit | 5 participants |
Secondary
Number of Participants With Abnormal Total Bilirubin Values
Participants with abnormal total bilirubin values
Time frame: Day 1 - 364
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 60mg | Number of Participants With Abnormal Total Bilirubin Values | >1.5 times upper limit | 2 participants |
| Degarelix 60mg | Number of Participants With Abnormal Total Bilirubin Values | Total abnormal (> upper limit) | 14 participants |
| Degarelix 60mg | Number of Participants With Abnormal Total Bilirubin Values | > upper limit - 1.5 times upper limit | 12 participants |
| Degarelix 60mg | Number of Participants With Abnormal Total Bilirubin Values | Total normal (<=upper limit) | 48 participants |
| Degarelix 60mg | Number of Participants With Abnormal Total Bilirubin Values | >2 times upper limit | 0 participants |
| Degarelix 80mg | Number of Participants With Abnormal Total Bilirubin Values | Total normal (<=upper limit) | 50 participants |
| Degarelix 80mg | Number of Participants With Abnormal Total Bilirubin Values | >2 times upper limit | 1 participants |
| Degarelix 80mg | Number of Participants With Abnormal Total Bilirubin Values | >1.5 times upper limit | 4 participants |
| Degarelix 80mg | Number of Participants With Abnormal Total Bilirubin Values | > upper limit - 1.5 times upper limit | 9 participants |
| Degarelix 80mg | Number of Participants With Abnormal Total Bilirubin Values | Total abnormal (> upper limit) | 14 participants |
Secondary
Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.
Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.
Time frame: Day 3
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 60mg | Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3. | 54 participants |
| Degarelix 80mg | Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3. | 56 participants |
95% CI: [79, 96]
95% CI: [78, 95]
p-value: 0.8413Chi-squared
Secondary
Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
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.
Time frame: Day 364
Population: ITT population. Diastolic blood pressure n=63,63 Pulse n=63,60 Systolic blood pressure n=63,64 Weight n=55,61
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 60mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure <= 50 and decrease >= 15 | 7 participants |
| Degarelix 60mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure >= 105 and increase >= 15 | 1 participants |
| Degarelix 60mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse <=50 and decrease of >=15 | 2 participants |
| Degarelix 60mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse >=120 and increase of >=15 | 0 participants |
| Degarelix 60mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure <=90 and decrease >=20 | 5 participants |
| Degarelix 60mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure >=180 and increase >=20 | 6 participants |
| Degarelix 60mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight decrease of >=7 percent | 2 participants |
| Degarelix 60mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight increase of >= 7 percent | 7 participants |
| Degarelix 80mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight increase of >= 7 percent | 4 participants |
| Degarelix 80mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure <= 50 and decrease >= 15 | 5 participants |
| Degarelix 80mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure <=90 and decrease >=20 | 5 participants |
| Degarelix 80mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure >= 105 and increase >= 15 | 2 participants |
| Degarelix 80mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight decrease of >=7 percent | 3 participants |
| Degarelix 80mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse <=50 and decrease of >=15 | 5 participants |
| Degarelix 80mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure >=180 and increase >=20 | 7 participants |
| Degarelix 80mg | Participants With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse >=120 and increase of >=15 | 0 participants |