| Primary | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | TRUS is a method of measuring the size of the prostate. | Full Analysis Set (FAS), Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Deviation | milliliter | | After treatment of 12 weeks compared to Baseline | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-37.2± 16.8
- OG001-39.0± 17.7
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Estimates from analysis of variance with treatment as factors and baseline IPSS and baseline Prostate volume as covariates. | ANCOVA | The baseline IPSS and baseline Prostate volume were used as covariates and treatment was used as a factor in the analysis. | 0.36 | | Mean Difference (Final Values) | 2.37 | | | 2-Sided | 95 | -2.78 | 7.52 | | | | Yes | Non-Inferiority or Equivalence | Non-inferiority was to be established if the treatment difference in adjusted (for baseline volume, and baseline total IPSS) mean percentage reduction was significantly greater (two-sided at α=0.05 level) than Δ = 10 points (non-inferiority margin) in both the FAS and PP analyses sets. If the Week 12 treatment assessment of prostate volume was missing the LOCF approach was used, i.e., the prostate volume value closest to and before Week 12 was used. |
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| Secondary | Change From Baseline in Prostate Size Based on TRUS at Week 4 and 8 | TRUS is a method of measuring the size of the prostate. | FAS, Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Deviation | milliliter | | After treatment of 4 and 8 weeks compared to Baseline | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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| Secondary | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. | FAS, Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Deviation | scores on a scale | | After treatment of 4, 8, and 12 weeks compared to Baseline | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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| Secondary | Change in Serum Testosterone Levels During the Study | | | Posted | | Median | Full Range | nanograms per milliliter | | At 4, 8, and 12 weeks compared to baseline. | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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| Secondary | Change in Serum Prostate-Specific Antigen (PSA) Levels During the Study | | | Posted | | Median | Full Range | nanograms per milliliter | | At 4, 8, and 12 weeks compared to baseline. | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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| Secondary | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). | | Posted | | Mean | Standard Deviation | scores on a scale | | After treatment of 4, 8, and 12 weeks compared to Baseline | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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| Secondary | Change From Baseline in Burden of Urinary Symptoms Based on the Benign Prostatic Hyperplasia Impact Index (BPHII) | The Benign Prostatic Hyperplasia Impact Index (BPHII) is a self-administered questionnaire to measure how much urinary problems affect various domains of health. The higher value the worse are the urinary problems. The minimum possible total value is 0 and the maximum possible total value is 16. | | Posted | | Mean | Standard Deviation | scores on a scale | | After treatment of 4, 8, and 12 weeks compared to Baseline | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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| Secondary | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value. | | Posted | | Number | | participants | | Baseline to 12 weeks of treatment | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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| Secondary | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study. | | Posted | | Number | | participants | | Baseline to 12 weeks of treatment | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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| Primary | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | TRUS is a method of measuring the size of the prostate. | Per Protocol (PP) Analysis Set, Last Observation Carried Forward (LOCF). | Posted | | Mean | Standard Deviation | milliliter | | After treatment of 12 weeks compared to Baseline | | | | ID | Title | Description |
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| OG000 | Degarelix 240 mg/80 mg | The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | | OG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin. |
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