Prostate Cancer
Conditions
Brief summary
The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.
Detailed description
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
Interventions
DRUGdegarelix
Degarelix was given as subcutaneous injections.
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
* Written informed consent prior to any study related procedures * Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy * ECOG score to be equal to or above 2 * Testosterone level within age-specific normal range * PSA value equal to or above 2 ng/ml * Life expectancy of at least 6 months
Exclusion criteria
* Previous or current hormonal treatment of prostate cancer * Recent or current treatment with any drugs modifying the testosterone level * Candidate for curative treatment such as prostatectomy or radiotherapy * History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema * Hypersensitivity towards any component of degarelix or mannitol * Cancer disease within the last 5 years except for prostate cancer and some skin cancers * Signs of liver impairment shown as elevated serum ALT or serum bilirubin * Known hepatic disease * Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results * Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator * Mental incapacity or language barrier precluding adequate understanding or cooperation * Having received an investigational product within the last 12 weeks preceding the trial * Previous participation in this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 | 12 months | Number of patients who achieved a testosterone level considered a castration level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 28 - 364 | 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. |
| Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. | Day 28 | The number of patients who achieved the \<=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle. |
| Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. | Day 3 | The number of patients who achieved the \<=0.5 nanogram/milliliter level for serum testosterone after 3 days. |
| Days to 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 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 two weeks apart. |
| Median Serum Testosterone Levels | Day 0 (Baseline), Days 1,3,7,14, and 364 | — |
| Days to 50 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 of the baseline value. |
| Median Values of Di-Hydrotestosterone | Day 0 (Baseline), Days 1, 3, 7, 14, and 364 | — |
| Median Values for Serum Luteinizing Hormone | Day 0 (Baseline), Days 1, 3, 7, 14, and 364 | — |
| Median Values for Follicle Stimulation Hormone | Day 0 (Baseline), Days 1, 3, 7, 14, and 364 | — |
| The Number of Patients With Abnormal Liver Function Tests | 364 days | 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. |
| The Number of Patients 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 patients in each group with normal baseline values and markedly abnormal end-of-study values. |
| Median Prostate-specific Antigen Levels | Day 0 (Baseline), Days 3, 7, 14, and 364 | — |
Countries
Belgium, Germany, Hungary, Netherlands, Poland, Romania, Russia, South Africa
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 32 |
| 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. | 32 |
| 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. | 30 |
| 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. | 33 |
| 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. | 30 |
| Total | 187 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 | 2 | 1 | 2 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 2 |
| Overall Study | Prostate-specific antigen progression | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 0 | 0 | 1 |
| 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 | Withdrawal by Subject | 0 | 3 | 2 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Degarelix 200/120 | Degarelix 200/160 | Degarelix 240/80 | Degarelix 200/80 | Degarelix 240/120 | Degarelix 240/160 | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 27 Participants | 27 Participants | 24 Participants | 23 Participants | 26 Participants | 23 Participants | 150 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 6 Participants | 7 Participants | 7 Participants | 7 Participants | 37 Participants |
| Age, Continuous | 70.6 years STANDARD_DEVIATION 7.72 | 73.3 years STANDARD_DEVIATION 7.39 | 70.4 years STANDARD_DEVIATION 7.07 | 69.9 years STANDARD_DEVIATION 8.27 | 70.7 years STANDARD_DEVIATION 7.56 | 70.7 years STANDARD_DEVIATION 8.59 | 70.9 years STANDARD_DEVIATION 7.75 |
| Body Mass Index | 26.4 kilograms per square meter STANDARD_DEVIATION 3.74 | 25.9 kilograms per square meter STANDARD_DEVIATION 4.46 | 27.7 kilograms per square meter STANDARD_DEVIATION 5.3 | 26.4 kilograms per square meter STANDARD_DEVIATION 3.5 | 26 kilograms per square meter STANDARD_DEVIATION 3.28 | 25.3 kilograms per square meter STANDARD_DEVIATION 2.73 | 26.3 kilograms per square meter STANDARD_DEVIATION 3.94 |
| Days Since Diagnosis of Prostate Cancer | 122 days STANDARD_DEVIATION 230 | 375 days STANDARD_DEVIATION 1098 | 383 days STANDARD_DEVIATION 817 | 493 days STANDARD_DEVIATION 849 | 229 days STANDARD_DEVIATION 508 | 352 days STANDARD_DEVIATION 743 | 323 days STANDARD_DEVIATION 756 |
| Median Serum Testosterone Level | 3.93 nanogram / milliliter | 4.79 nanogram / milliliter | 4.28 nanogram / milliliter | 4.47 nanogram / milliliter | 4.07 nanogram / milliliter | 3.88 nanogram / milliliter | 4.13 nanogram / milliliter |
| Number of Patients at Each Stage of Prostate Cancer Localized | 6 patients | 6 patients | 5 patients | 8 patients | 11 patients | 5 patients | 41 patients |
| Number of Patients at Each Stage of Prostate Cancer Locally advanced | 11 patients | 11 patients | 12 patients | 8 patients | 8 patients | 10 patients | 60 patients |
| Number of Patients at Each Stage of Prostate Cancer Metastatic | 8 patients | 5 patients | 5 patients | 4 patients | 7 patients | 7 patients | 36 patients |
| Number of Patients at Each Stage of Prostate Cancer Not classifiable | 7 patients | 10 patients | 8 patients | 10 patients | 7 patients | 8 patients | 50 patients |
| Patient Counts by Gleason Score 2-4 | 10 participants | 6 participants | 9 participants | 4 participants | 4 participants | 3 participants | 36 participants |
| Patient Counts by Gleason Score 5-6 | 10 participants | 14 participants | 10 participants | 13 participants | 17 participants | 12 participants | 76 participants |
| Patient Counts by Gleason Score 7-10 | 12 participants | 10 participants | 11 participants | 13 participants | 12 participants | 15 participants | 73 participants |
| Patient Counts by Gleason Score unknown | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 31 Participants | 30 Participants | 29 Participants | 30 Participants | 30 Participants | 180 Participants |
| Serum Prostate-specific Antigen | 31.5 nanogram / milliliter | 31.5 nanogram / milliliter | 23.1 nanogram / milliliter | 15.2 nanogram / milliliter | 35.3 nanogram / milliliter | 32 nanogram / milliliter | 27.6 nanogram / milliliter |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 32 Participants | 32 Participants | 30 Participants | 30 Participants | 33 Participants | 30 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / — | 21 / — | 24 / — | 19 / — | 23 / — | 20 / — |
| serious Total, serious adverse events | 3 / — | 6 / — | 4 / — | 4 / — | 6 / — | 4 / — |
Outcome results
Primary
Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
Number of patients who achieved a testosterone level considered a castration level.
Time frame: 12 months
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 200/80 | Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 | 17 participants |
| Degarelix 200/120 | Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 | 21 participants |
| Degarelix 200/160 | Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 | 26 participants |
| Degarelix 240/80 | Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 | 27 participants |
| Degarelix 240/120 | Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 | 27 participants |
| Degarelix 240/160 | Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 | 23 participants |
95% CI: [41, 78]
95% CI: [64, 95]
95% CI: [81, 100]
95% CI: [73, 98]
95% CI: [73, 98]
95% CI: [74, 99]
Secondary
Days to 50 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 of the baseline value.
Time frame: Day 0 (post dose) to Day 364
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 200/80 | Days to 50 Percent Reduction in Prostate-Specific Antigen | 14 days |
| Degarelix 200/120 | Days to 50 Percent Reduction in Prostate-Specific Antigen | 14 days |
| Degarelix 200/160 | Days to 50 Percent Reduction in Prostate-Specific Antigen | 14 days |
| Degarelix 240/80 | Days to 50 Percent Reduction in Prostate-Specific Antigen | 14 days |
| Degarelix 240/120 | Days to 50 Percent Reduction in Prostate-Specific Antigen | 14 days |
| Degarelix 240/160 | Days to 50 Percent Reduction in Prostate-Specific Antigen | 14 days |
p-value: 0.0933Log Rank
Secondary
Days to 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 90 percent of the baseline value.
Time frame: Day 0 (post dose) to Day 364
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 200/80 | Days to 90 Percent Reduction in Prostate-Specific Antigen | 56 days |
| Degarelix 200/120 | Days to 90 Percent Reduction in Prostate-Specific Antigen | 56 days |
| Degarelix 200/160 | Days to 90 Percent Reduction in Prostate-Specific Antigen | 56 days |
| Degarelix 240/80 | Days to 90 Percent Reduction in Prostate-Specific Antigen | 56 days |
| Degarelix 240/120 | Days to 90 Percent Reduction in Prostate-Specific Antigen | 56 days |
| Degarelix 240/160 | Days to 90 Percent Reduction in Prostate-Specific Antigen | 56 days |
p-value: 0.165Log 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 two weeks apart.
Time frame: Day 0 (post dose) to Day 364
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Degarelix 200/80 | Days to Prostate-Specific Antigen Progression | 224 days |
| Degarelix 200/120 | Days to Prostate-Specific Antigen Progression | 308 days |
| Degarelix 200/160 | Days to Prostate-Specific Antigen Progression | 280 days |
| Degarelix 240/80 | Days to Prostate-Specific Antigen Progression | 224 days |
| Degarelix 240/120 | Days to Prostate-Specific Antigen Progression | 140 days |
p-value: 0.429Log Rank
Secondary
Median Prostate-specific Antigen Levels
Time frame: Day 0 (Baseline), Days 3, 7, 14, and 364
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 200/80 | Median Prostate-specific Antigen Levels | Day 14 (n=29,31,32,29,33,28) | 7.9 nanogram / milliliter |
| Degarelix 200/80 | Median Prostate-specific Antigen Levels | Day 3 (n=29,30,28,29,33,28) | 13.7 nanogram / milliliter |
| Degarelix 200/80 | Median Prostate-specific Antigen Levels | Day 0 (Baseline) | 15.2 nanogram / milliliter |
| Degarelix 200/80 | Median Prostate-specific Antigen Levels | Day 364 (n=20,23,26,28,27,22) | 0.45 nanogram / milliliter |
| Degarelix 200/80 | Median Prostate-specific Antigen Levels | Day 7 (n=30,32,32,30,33,28) | 10.6 nanogram / milliliter |
| Degarelix 200/120 | Median Prostate-specific Antigen Levels | Day 3 (n=29,30,28,29,33,28) | 29.9 nanogram / milliliter |
| Degarelix 200/120 | Median Prostate-specific Antigen Levels | Day 14 (n=29,31,32,29,33,28) | 10.9 nanogram / milliliter |
| Degarelix 200/120 | Median Prostate-specific Antigen Levels | Day 0 (Baseline) | 31.5 nanogram / milliliter |
| Degarelix 200/120 | Median Prostate-specific Antigen Levels | Day 364 (n=20,23,26,28,27,22) | 0.6 nanogram / milliliter |
| Degarelix 200/120 | Median Prostate-specific Antigen Levels | Day 7 (n=30,32,32,30,33,28) | 18.5 nanogram / milliliter |
| Degarelix 200/160 | Median Prostate-specific Antigen Levels | Day 3 (n=29,30,28,29,33,28) | 27.8 nanogram / milliliter |
| Degarelix 200/160 | Median Prostate-specific Antigen Levels | Day 14 (n=29,31,32,29,33,28) | 9.9 nanogram / milliliter |
| Degarelix 200/160 | Median Prostate-specific Antigen Levels | Day 364 (n=20,23,26,28,27,22) | 0.95 nanogram / milliliter |
| Degarelix 200/160 | Median Prostate-specific Antigen Levels | Day 7 (n=30,32,32,30,33,28) | 16.5 nanogram / milliliter |
| Degarelix 200/160 | Median Prostate-specific Antigen Levels | Day 0 (Baseline) | 31.5 nanogram / milliliter |
| Degarelix 240/80 | Median Prostate-specific Antigen Levels | Day 7 (n=30,32,32,30,33,28) | 14.8 nanogram / milliliter |
| Degarelix 240/80 | Median Prostate-specific Antigen Levels | Day 0 (Baseline) | 23.1 nanogram / milliliter |
| Degarelix 240/80 | Median Prostate-specific Antigen Levels | Day 3 (n=29,30,28,29,33,28) | 22.2 nanogram / milliliter |
| Degarelix 240/80 | Median Prostate-specific Antigen Levels | Day 14 (n=29,31,32,29,33,28) | 7.1 nanogram / milliliter |
| Degarelix 240/80 | Median Prostate-specific Antigen Levels | Day 364 (n=20,23,26,28,27,22) | 0.9 nanogram / milliliter |
| Degarelix 240/120 | Median Prostate-specific Antigen Levels | Day 14 (n=29,31,32,29,33,28) | 13.4 nanogram / milliliter |
| Degarelix 240/120 | Median Prostate-specific Antigen Levels | Day 0 (Baseline) | 35.3 nanogram / milliliter |
| Degarelix 240/120 | Median Prostate-specific Antigen Levels | Day 364 (n=20,23,26,28,27,22) | 0.8 nanogram / milliliter |
| Degarelix 240/120 | Median Prostate-specific Antigen Levels | Day 3 (n=29,30,28,29,33,28) | 26.3 nanogram / milliliter |
| Degarelix 240/120 | Median Prostate-specific Antigen Levels | Day 7 (n=30,32,32,30,33,28) | 20.8 nanogram / milliliter |
| Degarelix 240/160 | Median Prostate-specific Antigen Levels | Day 0 (Baseline) | 32 nanogram / milliliter |
| Degarelix 240/160 | Median Prostate-specific Antigen Levels | Day 14 (n=29,31,32,29,33,28) | 8.35 nanogram / milliliter |
| Degarelix 240/160 | Median Prostate-specific Antigen Levels | Day 3 (n=29,30,28,29,33,28) | 25.2 nanogram / milliliter |
| Degarelix 240/160 | Median Prostate-specific Antigen Levels | Day 364 (n=20,23,26,28,27,22) | 0.3 nanogram / milliliter |
| Degarelix 240/160 | Median Prostate-specific Antigen Levels | Day 7 (n=30,32,32,30,33,28) | 16.9 nanogram / milliliter |
Secondary
Median Serum Testosterone Levels
Time frame: Day 0 (Baseline), Days 1,3,7,14, and 364
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 200/80 | Median Serum Testosterone Levels | Day 3 (n=30,32,31,30,33,30) | 0.308 nanogram/milliliter |
| Degarelix 200/80 | Median Serum Testosterone Levels | Day 14 (n=30,32,32,30,33,29) | 0.173 nanogram/milliliter |
| Degarelix 200/80 | Median Serum Testosterone Levels | Day 364 (n=20,23,26,28,27,23) | 0.137 nanogram/milliliter |
| Degarelix 200/80 | Median Serum Testosterone Levels | Day 1 (n=30,32,32,30,33,30) | 0.654 nanogram/milliliter |
| Degarelix 200/80 | Median Serum Testosterone Levels | Day 7 (n=30,32,32,30,33,28) | 0.283 nanogram/milliliter |
| Degarelix 200/80 | Median Serum Testosterone Levels | Day 0 (Baseline) | 4.47 nanogram/milliliter |
| Degarelix 200/120 | Median Serum Testosterone Levels | Day 7 (n=30,32,32,30,33,28) | 0.237 nanogram/milliliter |
| Degarelix 200/120 | Median Serum Testosterone Levels | Day 0 (Baseline) | 3.93 nanogram/milliliter |
| Degarelix 200/120 | Median Serum Testosterone Levels | Day 14 (n=30,32,32,30,33,29) | 0.144 nanogram/milliliter |
| Degarelix 200/120 | Median Serum Testosterone Levels | Day 3 (n=30,32,31,30,33,30) | 0.26 nanogram/milliliter |
| Degarelix 200/120 | Median Serum Testosterone Levels | Day 364 (n=20,23,26,28,27,23) | 0.124 nanogram/milliliter |
| Degarelix 200/120 | Median Serum Testosterone Levels | Day 1 (n=30,32,32,30,33,30) | 0.436 nanogram/milliliter |
| Degarelix 200/160 | Median Serum Testosterone Levels | Day 7 (n=30,32,32,30,33,28) | 0.198 nanogram/milliliter |
| Degarelix 200/160 | Median Serum Testosterone Levels | Day 3 (n=30,32,31,30,33,30) | 0.281 nanogram/milliliter |
| Degarelix 200/160 | Median Serum Testosterone Levels | Day 0 (Baseline) | 4.79 nanogram/milliliter |
| Degarelix 200/160 | Median Serum Testosterone Levels | Day 1 (n=30,32,32,30,33,30) | 0.465 nanogram/milliliter |
| Degarelix 200/160 | Median Serum Testosterone Levels | Day 14 (n=30,32,32,30,33,29) | 0.122 nanogram/milliliter |
| Degarelix 200/160 | Median Serum Testosterone Levels | Day 364 (n=20,23,26,28,27,23) | 0.105 nanogram/milliliter |
| Degarelix 240/80 | Median Serum Testosterone Levels | Day 1 (n=30,32,32,30,33,30) | 0.563 nanogram/milliliter |
| Degarelix 240/80 | Median Serum Testosterone Levels | Day 7 (n=30,32,32,30,33,28) | 0.193 nanogram/milliliter |
| Degarelix 240/80 | Median Serum Testosterone Levels | Day 0 (Baseline) | 4.28 nanogram/milliliter |
| Degarelix 240/80 | Median Serum Testosterone Levels | Day 3 (n=30,32,31,30,33,30) | 0.265 nanogram/milliliter |
| Degarelix 240/80 | Median Serum Testosterone Levels | Day 364 (n=20,23,26,28,27,23) | 0.126 nanogram/milliliter |
| Degarelix 240/80 | Median Serum Testosterone Levels | Day 14 (n=30,32,32,30,33,29) | 0.152 nanogram/milliliter |
| Degarelix 240/120 | Median Serum Testosterone Levels | Day 7 (n=30,32,32,30,33,28) | 0.216 nanogram/milliliter |
| Degarelix 240/120 | Median Serum Testosterone Levels | Day 14 (n=30,32,32,30,33,29) | 0.134 nanogram/milliliter |
| Degarelix 240/120 | Median Serum Testosterone Levels | Day 1 (n=30,32,32,30,33,30) | 0.453 nanogram/milliliter |
| Degarelix 240/120 | Median Serum Testosterone Levels | Day 364 (n=20,23,26,28,27,23) | 0.12 nanogram/milliliter |
| Degarelix 240/120 | Median Serum Testosterone Levels | Day 0 (Baseline) | 4.07 nanogram/milliliter |
| Degarelix 240/120 | Median Serum Testosterone Levels | Day 3 (n=30,32,31,30,33,30) | 0.268 nanogram/milliliter |
| Degarelix 240/160 | Median Serum Testosterone Levels | Day 0 (Baseline) | 3.88 nanogram/milliliter |
| Degarelix 240/160 | Median Serum Testosterone Levels | Day 1 (n=30,32,32,30,33,30) | 0.576 nanogram/milliliter |
| Degarelix 240/160 | Median Serum Testosterone Levels | Day 7 (n=30,32,32,30,33,28) | 0.207 nanogram/milliliter |
| Degarelix 240/160 | Median Serum Testosterone Levels | Day 14 (n=30,32,32,30,33,29) | 0.126 nanogram/milliliter |
| Degarelix 240/160 | Median Serum Testosterone Levels | Day 364 (n=20,23,26,28,27,23) | 0.124 nanogram/milliliter |
| Degarelix 240/160 | Median Serum Testosterone Levels | Day 3 (n=30,32,31,30,33,30) | 0.261 nanogram/milliliter |
Secondary
Median Values for Follicle Stimulation Hormone
Time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 200/80 | Median Values for Follicle Stimulation Hormone | Day 0 (Baseline) | 8.35 international units / liter |
| Degarelix 200/80 | Median Values for Follicle Stimulation Hormone | Day 1 (n=28,30,32,28,31,30) | 5.15 international units / liter |
| Degarelix 200/80 | Median Values for Follicle Stimulation Hormone | Day 3 (n=29,30,28,29,33,28) | 2.9 international units / liter |
| Degarelix 200/80 | Median Values for Follicle Stimulation Hormone | Day 7 (n=30,32,32,30,33,28) | 2.7 international units / liter |
| Degarelix 200/80 | Median Values for Follicle Stimulation Hormone | Day 14 (n=29,31,32,29,33,28) | 1.6 international units / liter |
| Degarelix 200/80 | Median Values for Follicle Stimulation Hormone | Day 364 (n=20,23,26,28,27,22) | 1.8 international units / liter |
| Degarelix 200/120 | Median Values for Follicle Stimulation Hormone | Day 1 (n=28,30,32,28,31,30) | 5.65 international units / liter |
| Degarelix 200/120 | Median Values for Follicle Stimulation Hormone | Day 7 (n=30,32,32,30,33,28) | 1.95 international units / liter |
| Degarelix 200/120 | Median Values for Follicle Stimulation Hormone | Day 364 (n=20,23,26,28,27,22) | 1.5 international units / liter |
| Degarelix 200/120 | Median Values for Follicle Stimulation Hormone | Day 0 (Baseline) | 9.25 international units / liter |
| Degarelix 200/120 | Median Values for Follicle Stimulation Hormone | Day 3 (n=29,30,28,29,33,28) | 3.15 international units / liter |
| Degarelix 200/120 | Median Values for Follicle Stimulation Hormone | Day 14 (n=29,31,32,29,33,28) | 1.1 international units / liter |
| Degarelix 200/160 | Median Values for Follicle Stimulation Hormone | Day 364 (n=20,23,26,28,27,22) | 1.45 international units / liter |
| Degarelix 200/160 | Median Values for Follicle Stimulation Hormone | Day 14 (n=29,31,32,29,33,28) | 0.9 international units / liter |
| Degarelix 200/160 | Median Values for Follicle Stimulation Hormone | Day 7 (n=30,32,32,30,33,28) | 1.85 international units / liter |
| Degarelix 200/160 | Median Values for Follicle Stimulation Hormone | Day 3 (n=29,30,28,29,33,28) | 3.25 international units / liter |
| Degarelix 200/160 | Median Values for Follicle Stimulation Hormone | Day 0 (Baseline) | 9 international units / liter |
| Degarelix 200/160 | Median Values for Follicle Stimulation Hormone | Day 1 (n=28,30,32,28,31,30) | 5.35 international units / liter |
| Degarelix 240/80 | Median Values for Follicle Stimulation Hormone | Day 7 (n=30,32,32,30,33,28) | 1.85 international units / liter |
| Degarelix 240/80 | Median Values for Follicle Stimulation Hormone | Day 1 (n=28,30,32,28,31,30) | 6.2 international units / liter |
| Degarelix 240/80 | Median Values for Follicle Stimulation Hormone | Day 3 (n=29,30,28,29,33,28) | 3.3 international units / liter |
| Degarelix 240/80 | Median Values for Follicle Stimulation Hormone | Day 364 (n=20,23,26,28,27,22) | 1.75 international units / liter |
| Degarelix 240/80 | Median Values for Follicle Stimulation Hormone | Day 14 (n=29,31,32,29,33,28) | 0.8 international units / liter |
| Degarelix 240/80 | Median Values for Follicle Stimulation Hormone | Day 0 (Baseline) | 9.7 international units / liter |
| Degarelix 240/120 | Median Values for Follicle Stimulation Hormone | Day 0 (Baseline) | 7 international units / liter |
| Degarelix 240/120 | Median Values for Follicle Stimulation Hormone | Day 14 (n=29,31,32,29,33,28) | 0.7 international units / liter |
| Degarelix 240/120 | Median Values for Follicle Stimulation Hormone | Day 1 (n=28,30,32,28,31,30) | 4.4 international units / liter |
| Degarelix 240/120 | Median Values for Follicle Stimulation Hormone | Day 3 (n=29,30,28,29,33,28) | 2.5 international units / liter |
| Degarelix 240/120 | Median Values for Follicle Stimulation Hormone | Day 7 (n=30,32,32,30,33,28) | 1.4 international units / liter |
| Degarelix 240/120 | Median Values for Follicle Stimulation Hormone | Day 364 (n=20,23,26,28,27,22) | 1.1 international units / liter |
| Degarelix 240/160 | Median Values for Follicle Stimulation Hormone | Day 7 (n=30,32,32,30,33,28) | 2.55 international units / liter |
| Degarelix 240/160 | Median Values for Follicle Stimulation Hormone | Day 3 (n=29,30,28,29,33,28) | 3.1 international units / liter |
| Degarelix 240/160 | Median Values for Follicle Stimulation Hormone | Day 14 (n=29,31,32,29,33,28) | 0.95 international units / liter |
| Degarelix 240/160 | Median Values for Follicle Stimulation Hormone | Day 364 (n=20,23,26,28,27,22) | 2.2 international units / liter |
| Degarelix 240/160 | Median Values for Follicle Stimulation Hormone | Day 1 (n=28,30,32,28,31,30) | 5.9 international units / liter |
| Degarelix 240/160 | Median Values for Follicle Stimulation Hormone | Day 0 (Baseline) | 10.2 international units / liter |
Secondary
Median Values for Serum Luteinizing Hormone
Time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 200/80 | Median Values for Serum Luteinizing Hormone | Day 0 (Baseline) | 3.8 international units / liter |
| Degarelix 200/80 | Median Values for Serum Luteinizing Hormone | Day 1 (n=28,30,32,28,31,30) | 0.8 international units / liter |
| Degarelix 200/80 | Median Values for Serum Luteinizing Hormone | Day 3 (n=29,30,28,29,33,28) | 0.5 international units / liter |
| Degarelix 200/80 | Median Values for Serum Luteinizing Hormone | Day 7 (n=30,32,32,30,33,28) | 0.7 international units / liter |
| Degarelix 200/80 | Median Values for Serum Luteinizing Hormone | Day 14 (n=29,31,32,29,33,28) | 0.5 international units / liter |
| Degarelix 200/80 | Median Values for Serum Luteinizing Hormone | Day 364 (n=20,23,26,28,27,22) | 0.3 international units / liter |
| Degarelix 200/120 | Median Values for Serum Luteinizing Hormone | Day 1 (n=28,30,32,28,31,30) | 0.65 international units / liter |
| Degarelix 200/120 | Median Values for Serum Luteinizing Hormone | Day 7 (n=30,32,32,30,33,28) | 0.5 international units / liter |
| Degarelix 200/120 | Median Values for Serum Luteinizing Hormone | Day 364 (n=20,23,26,28,27,22) | 0.3 international units / liter |
| Degarelix 200/120 | Median Values for Serum Luteinizing Hormone | Day 0 (Baseline) | 4 international units / liter |
| Degarelix 200/120 | Median Values for Serum Luteinizing Hormone | Day 3 (n=29,30,28,29,33,28) | 0.5 international units / liter |
| Degarelix 200/120 | Median Values for Serum Luteinizing Hormone | Day 14 (n=29,31,32,29,33,28) | 0.3 international units / liter |
| Degarelix 200/160 | Median Values for Serum Luteinizing Hormone | Day 364 (n=20,23,26,28,27,22) | 0.2 international units / liter |
| Degarelix 200/160 | Median Values for Serum Luteinizing Hormone | Day 14 (n=29,31,32,29,33,28) | 0.35 international units / liter |
| Degarelix 200/160 | Median Values for Serum Luteinizing Hormone | Day 7 (n=30,32,32,30,33,28) | 0.6 international units / liter |
| Degarelix 200/160 | Median Values for Serum Luteinizing Hormone | Day 3 (n=29,30,28,29,33,28) | 0.5 international units / liter |
| Degarelix 200/160 | Median Values for Serum Luteinizing Hormone | Day 0 (Baseline) | 5.05 international units / liter |
| Degarelix 200/160 | Median Values for Serum Luteinizing Hormone | Day 1 (n=28,30,32,28,31,30) | 0.7 international units / liter |
| Degarelix 240/80 | Median Values for Serum Luteinizing Hormone | Day 7 (n=30,32,32,30,33,28) | 0.5 international units / liter |
| Degarelix 240/80 | Median Values for Serum Luteinizing Hormone | Day 1 (n=28,30,32,28,31,30) | 0.9 international units / liter |
| Degarelix 240/80 | Median Values for Serum Luteinizing Hormone | Day 3 (n=29,30,28,29,33,28) | 0.5 international units / liter |
| Degarelix 240/80 | Median Values for Serum Luteinizing Hormone | Day 364 (n=20,23,26,28,27,22) | 0.4 international units / liter |
| Degarelix 240/80 | Median Values for Serum Luteinizing Hormone | Day 14 (n=29,31,32,29,33,28) | 0.3 international units / liter |
| Degarelix 240/80 | Median Values for Serum Luteinizing Hormone | Day 0 (Baseline) | 5.6 international units / liter |
| Degarelix 240/120 | Median Values for Serum Luteinizing Hormone | Day 0 (Baseline) | 3.9 international units / liter |
| Degarelix 240/120 | Median Values for Serum Luteinizing Hormone | Day 14 (n=29,31,32,29,33,28) | 0.3 international units / liter |
| Degarelix 240/120 | Median Values for Serum Luteinizing Hormone | Day 1 (n=28,30,32,28,31,30) | 0.7 international units / liter |
| Degarelix 240/120 | Median Values for Serum Luteinizing Hormone | Day 3 (n=29,30,28,29,33,28) | 0.4 international units / liter |
| Degarelix 240/120 | Median Values for Serum Luteinizing Hormone | Day 7 (n=30,32,32,30,33,28) | 0.5 international units / liter |
| Degarelix 240/120 | Median Values for Serum Luteinizing Hormone | Day 364 (n=20,23,26,28,27,22) | 0.2 international units / liter |
| Degarelix 240/160 | Median Values for Serum Luteinizing Hormone | Day 7 (n=30,32,32,30,33,28) | 0.75 international units / liter |
| Degarelix 240/160 | Median Values for Serum Luteinizing Hormone | Day 3 (n=29,30,28,29,33,28) | 0.55 international units / liter |
| Degarelix 240/160 | Median Values for Serum Luteinizing Hormone | Day 14 (n=29,31,32,29,33,28) | 0.3 international units / liter |
| Degarelix 240/160 | Median Values for Serum Luteinizing Hormone | Day 364 (n=20,23,26,28,27,22) | 0.3 international units / liter |
| Degarelix 240/160 | Median Values for Serum Luteinizing Hormone | Day 1 (n=28,30,32,28,31,30) | 0.75 international units / liter |
| Degarelix 240/160 | Median Values for Serum Luteinizing Hormone | Day 0 (Baseline) | 6 international units / liter |
Secondary
Median Values of Di-Hydrotestosterone
Time frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
Population: ITT population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Degarelix 200/80 | Median Values of Di-Hydrotestosterone | Day 0 (Baseline; n=25,30,26,23,23,25) | 430 picogram / milliliter |
| Degarelix 200/80 | Median Values of Di-Hydrotestosterone | Day 1 (n=23,27,25,24,26,24) | 130 picogram / milliliter |
| Degarelix 200/80 | Median Values of Di-Hydrotestosterone | Day 3 (n=23,27,25,25,27,25) | 82 picogram / milliliter |
| Degarelix 200/80 | Median Values of Di-Hydrotestosterone | Day 7 (n=26,30,24,26,30,22) | 63 picogram / milliliter |
| Degarelix 200/80 | Median Values of Di-Hydrotestosterone | Day 14 (n=19,27,25,23,25,27) | 68 picogram / milliliter |
| Degarelix 200/80 | Median Values of Di-Hydrotestosterone | Day 364 (n=17,21,20,25,25,21) | 41 picogram / milliliter |
| Degarelix 200/120 | Median Values of Di-Hydrotestosterone | Day 1 (n=23,27,25,24,26,24) | 95 picogram / milliliter |
| Degarelix 200/120 | Median Values of Di-Hydrotestosterone | Day 7 (n=26,30,24,26,30,22) | 65 picogram / milliliter |
| Degarelix 200/120 | Median Values of Di-Hydrotestosterone | Day 364 (n=17,21,20,25,25,21) | 39 picogram / milliliter |
| Degarelix 200/120 | Median Values of Di-Hydrotestosterone | Day 0 (Baseline; n=25,30,26,23,23,25) | 330 picogram / milliliter |
| Degarelix 200/120 | Median Values of Di-Hydrotestosterone | Day 3 (n=23,27,25,25,27,25) | 67 picogram / milliliter |
| Degarelix 200/120 | Median Values of Di-Hydrotestosterone | Day 14 (n=19,27,25,23,25,27) | 51 picogram / milliliter |
| Degarelix 200/160 | Median Values of Di-Hydrotestosterone | Day 364 (n=17,21,20,25,25,21) | 34 picogram / milliliter |
| Degarelix 200/160 | Median Values of Di-Hydrotestosterone | Day 14 (n=19,27,25,23,25,27) | 42 picogram / milliliter |
| Degarelix 200/160 | Median Values of Di-Hydrotestosterone | Day 7 (n=26,30,24,26,30,22) | 61.5 picogram / milliliter |
| Degarelix 200/160 | Median Values of Di-Hydrotestosterone | Day 3 (n=23,27,25,25,27,25) | 70 picogram / milliliter |
| Degarelix 200/160 | Median Values of Di-Hydrotestosterone | Day 0 (Baseline; n=25,30,26,23,23,25) | 310 picogram / milliliter |
| Degarelix 200/160 | Median Values of Di-Hydrotestosterone | Day 1 (n=23,27,25,24,26,24) | 110 picogram / milliliter |
| Degarelix 240/80 | Median Values of Di-Hydrotestosterone | Day 7 (n=26,30,24,26,30,22) | 56.5 picogram / milliliter |
| Degarelix 240/80 | Median Values of Di-Hydrotestosterone | Day 1 (n=23,27,25,24,26,24) | 130 picogram / milliliter |
| Degarelix 240/80 | Median Values of Di-Hydrotestosterone | Day 3 (n=23,27,25,25,27,25) | 66 picogram / milliliter |
| Degarelix 240/80 | Median Values of Di-Hydrotestosterone | Day 364 (n=17,21,20,25,25,21) | 40 picogram / milliliter |
| Degarelix 240/80 | Median Values of Di-Hydrotestosterone | Day 14 (n=19,27,25,23,25,27) | 57 picogram / milliliter |
| Degarelix 240/80 | Median Values of Di-Hydrotestosterone | Day 0 (Baseline; n=25,30,26,23,23,25) | 330 picogram / milliliter |
| Degarelix 240/120 | Median Values of Di-Hydrotestosterone | Day 0 (Baseline; n=25,30,26,23,23,25) | 350 picogram / milliliter |
| Degarelix 240/120 | Median Values of Di-Hydrotestosterone | Day 14 (n=19,27,25,23,25,27) | 59 picogram / milliliter |
| Degarelix 240/120 | Median Values of Di-Hydrotestosterone | Day 1 (n=23,27,25,24,26,24) | 110 picogram / milliliter |
| Degarelix 240/120 | Median Values of Di-Hydrotestosterone | Day 3 (n=23,27,25,25,27,25) | 73 picogram / milliliter |
| Degarelix 240/120 | Median Values of Di-Hydrotestosterone | Day 7 (n=26,30,24,26,30,22) | 61 picogram / milliliter |
| Degarelix 240/120 | Median Values of Di-Hydrotestosterone | Day 364 (n=17,21,20,25,25,21) | 39 picogram / milliliter |
| Degarelix 240/160 | Median Values of Di-Hydrotestosterone | Day 7 (n=26,30,24,26,30,22) | 77.5 picogram / milliliter |
| Degarelix 240/160 | Median Values of Di-Hydrotestosterone | Day 3 (n=23,27,25,25,27,25) | 67 picogram / milliliter |
| Degarelix 240/160 | Median Values of Di-Hydrotestosterone | Day 14 (n=19,27,25,23,25,27) | 53 picogram / milliliter |
| Degarelix 240/160 | Median Values of Di-Hydrotestosterone | Day 364 (n=17,21,20,25,25,21) | 40 picogram / milliliter |
| Degarelix 240/160 | Median Values of Di-Hydrotestosterone | Day 1 (n=23,27,25,24,26,24) | 115 picogram / milliliter |
| Degarelix 240/160 | Median Values of Di-Hydrotestosterone | Day 0 (Baseline; n=25,30,26,23,23,25) | 290 picogram / milliliter |
Secondary
Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
The number of patients who achieved the \<=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
Time frame: Day 28
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 200/80 | Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. | 21 participants |
| Degarelix 200/120 | Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. | 29 participants |
| Degarelix 200/160 | Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. | 31 participants |
| Degarelix 240/80 | Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. | 29 participants |
| Degarelix 240/120 | Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. | 31 participants |
| Degarelix 240/160 | Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. | 27 participants |
95% CI: [51, 85]
95% CI: [75, 98]
95% CI: [84, 100]
95% CI: [83, 100]
95% CI: [80, 99]
95% CI: [77, 99]
Secondary
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
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.
Time frame: Day 28 - 364
Population: ITT population of patients with testoterone measurements \<=0.5 nanogram/milliliter at Day 28.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 200/80 | 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 |
| Degarelix 200/120 | 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 | 48 participants |
| Degarelix 200/160 | 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 | 49 participants |
95% CI: [80, 98]
95% CI: [86, 100]
95% CI: [93, 100]
Secondary
Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
The number of patients who achieved the \<=0.5 nanogram/milliliter level for serum testosterone after 3 days.
Time frame: Day 3
Population: ITT population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Degarelix 200/80 | Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. | 25 participants |
| Degarelix 200/120 | Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. | 30 participants |
| Degarelix 200/160 | Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. | 27 participants |
| Degarelix 240/80 | Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. | 28 participants |
| Degarelix 240/120 | Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. | 30 participants |
| Degarelix 240/160 | Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. | 28 participants |
95% CI: [65, 94]
95% CI: [79, 99]
95% CI: [70, 96]
95% CI: [78, 99]
95% CI: [76, 98]
95% CI: [78, 99]
Secondary
The Number of Patients With Abnormal Liver Function Tests
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.
Time frame: 364 days
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 200/80 | The Number of Patients With Abnormal Liver Function Tests | ALT >3x ULN | 3 participants |
| Degarelix 200/80 | The Number of Patients With Abnormal Liver Function Tests | Abnormal aspartate aminotransferase | 7 participants |
| Degarelix 200/80 | The Number of Patients With Abnormal Liver Function Tests | Abnormal alanine aminotransferase (ALT) | 6 participants |
| Degarelix 200/80 | The Number of Patients With Abnormal Liver Function Tests | ALT>3x ULN and bilirubin >1.5x ULN | 0 participants |
| Degarelix 200/80 | The Number of Patients With Abnormal Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 200/120 | The Number of Patients With Abnormal Liver Function Tests | Abnormal aspartate aminotransferase | 10 participants |
| Degarelix 200/120 | The Number of Patients With Abnormal Liver Function Tests | ALT >3x ULN | 8 participants |
| Degarelix 200/120 | The Number of Patients With Abnormal Liver Function Tests | Abnormal alanine aminotransferase (ALT) | 10 participants |
| Degarelix 200/120 | The Number of Patients With Abnormal Liver Function Tests | ALT>3x ULN and bilirubin >1.5x ULN | 0 participants |
| Degarelix 200/120 | The Number of Patients With Abnormal Liver Function Tests | Abnormal bilirubin | 5 participants |
| Degarelix 200/160 | The Number of Patients With Abnormal Liver Function Tests | Abnormal aspartate aminotransferase | 15 participants |
| Degarelix 200/160 | The Number of Patients With Abnormal Liver Function Tests | ALT >3x ULN | 12 participants |
| Degarelix 200/160 | The Number of Patients With Abnormal Liver Function Tests | ALT>3x ULN and bilirubin >1.5x ULN | 0 participants |
| Degarelix 200/160 | The Number of Patients With Abnormal Liver Function Tests | Abnormal bilirubin | 1 participants |
| Degarelix 200/160 | The Number of Patients With Abnormal Liver Function Tests | Abnormal alanine aminotransferase (ALT) | 15 participants |
| Degarelix 240/80 | The Number of Patients With Abnormal Liver Function Tests | Abnormal bilirubin | 2 participants |
| Degarelix 240/80 | The Number of Patients With Abnormal Liver Function Tests | Abnormal alanine aminotransferase (ALT) | 13 participants |
| Degarelix 240/80 | The Number of Patients With Abnormal Liver Function Tests | Abnormal aspartate aminotransferase | 8 participants |
| Degarelix 240/80 | The Number of Patients With Abnormal Liver Function Tests | ALT >3x ULN | 13 participants |
| Degarelix 240/80 | The Number of Patients With Abnormal Liver Function Tests | ALT>3x ULN and bilirubin >1.5x ULN | 0 participants |
| Degarelix 240/120 | The Number of Patients With Abnormal Liver Function Tests | ALT >3x ULN | 7 participants |
| Degarelix 240/120 | The Number of Patients With Abnormal Liver Function Tests | Abnormal alanine aminotransferase (ALT) | 8 participants |
| Degarelix 240/120 | The Number of Patients With Abnormal Liver Function Tests | ALT>3x ULN and bilirubin >1.5x ULN | 0 participants |
| Degarelix 240/120 | The Number of Patients With Abnormal Liver Function Tests | Abnormal aspartate aminotransferase | 13 participants |
| Degarelix 240/120 | The Number of Patients With Abnormal Liver Function Tests | Abnormal bilirubin | 5 participants |
| Degarelix 240/160 | The Number of Patients With Abnormal Liver Function Tests | Abnormal alanine aminotransferase (ALT) | 9 participants |
| Degarelix 240/160 | The Number of Patients With Abnormal Liver Function Tests | ALT >3x ULN | 8 participants |
| Degarelix 240/160 | The Number of Patients With Abnormal Liver Function Tests | Abnormal aspartate aminotransferase | 13 participants |
| Degarelix 240/160 | The Number of Patients With Abnormal Liver Function Tests | ALT>3x ULN and bilirubin >1.5x ULN | 0 participants |
| Degarelix 240/160 | The Number of Patients With Abnormal Liver Function Tests | Abnormal bilirubin | 1 participants |
Secondary
The Number of Patients 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 patients in each group with normal baseline values and markedly abnormal end-of-study values.
Time frame: Day 364
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Degarelix 200/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse <=50 and decrease >=15 from baseline | 0 participants |
| Degarelix 200/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure >=105 and increase >=15 | 3 participants |
| Degarelix 200/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 200/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse >=120 and increase of >=15 from baseline | 0 participants |
| Degarelix 200/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 200/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure >=180 and increase >=20 | 3 participants |
| Degarelix 200/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight decrease of >=7% from baseline | 0 participants |
| Degarelix 200/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight increase of >=7% from baseline | 3 participants |
| Degarelix 200/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse >=120 and increase of >=15 from baseline | 0 participants |
| Degarelix 200/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight increase of >=7% from baseline | 4 participants |
| Degarelix 200/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 200/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight decrease of >=7% from baseline | 1 participants |
| Degarelix 200/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure >=180 and increase >=20 | 2 participants |
| Degarelix 200/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse <=50 and decrease >=15 from baseline | 2 participants |
| Degarelix 200/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure >=105 and increase >=15 | 3 participants |
| Degarelix 200/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 200/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure >=105 and increase >=15 | 4 participants |
| Degarelix 200/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse <=50 and decrease >=15 from baseline | 0 participants |
| Degarelix 200/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse >=120 and increase of >=15 from baseline | 0 participants |
| Degarelix 200/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight increase of >=7% from baseline | 6 participants |
| Degarelix 200/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure <=90 and decrease >=20 | 1 participants |
| Degarelix 200/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure >=180 and increase >=20 | 4 participants |
| Degarelix 200/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight decrease of >=7% from baseline | 1 participants |
| Degarelix 200/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 0 participants |
| Degarelix 240/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight decrease of >=7% from baseline | 3 participants |
| Degarelix 240/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure >=180 and increase >=20 | 0 participants |
| Degarelix 240/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 240/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 2 participants |
| Degarelix 240/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse <=50 and decrease >=15 from baseline | 2 participants |
| Degarelix 240/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse >=120 and increase of >=15 from baseline | 1 participants |
| Degarelix 240/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight increase of >=7% from baseline | 5 participants |
| Degarelix 240/80 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure >=105 and increase >=15 | 3 participants |
| Degarelix 240/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight increase of >=7% from baseline | 4 participants |
| Degarelix 240/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 2 participants |
| Degarelix 240/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 240/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure >=180 and increase >=20 | 3 participants |
| Degarelix 240/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight decrease of >=7% from baseline | 1 participants |
| Degarelix 240/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure >=105 and increase >=15 | 0 participants |
| Degarelix 240/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse <=50 and decrease >=15 from baseline | 1 participants |
| Degarelix 240/120 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse >=120 and increase of >=15 from baseline | 0 participants |
| Degarelix 240/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight increase of >=7% from baseline | 1 participants |
| Degarelix 240/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure <=90 and decrease >=20 | 0 participants |
| Degarelix 240/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse <=50 and decrease >=15 from baseline | 1 participants |
| Degarelix 240/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Pulse >=120 and increase of >=15 from baseline | 0 participants |
| Degarelix 240/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Systolic blood pressure >=180 and increase >=20 | 2 participants |
| Degarelix 240/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure >=105 and increase >=15 | 2 participants |
| Degarelix 240/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Weight decrease of >=7% from baseline | 0 participants |
| Degarelix 240/160 | The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight | Diastolic blood pressure <=50 and decrease >=15 | 2 participants |