Lower Urinary Tract Symptoms (LUTS)
Conditions
Brief summary
A dose-finding, multi-centre, double-blind, randomised, parallel, placebo-controlled trial to investigate efficacy and safety of degarelix in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH)
Interventions
DRUGPlacebo
Mannitol 50 mg/mL solution
DRUGDegarelix 10 mg
10 mg degarelix, 40 mg/mL solution
DRUGDegarelix 20 mg
20 mg degarelix, 40 mg/mL solution
DRUGDegarelix 30 mg
30 mg degarelix, 40 mg/mL solution
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent obtained before any trial-related activity is performed * Men, aged 50 or older * Clinical signs and symptoms of BPH for ≥6 months * Moderate to severe LUTS at screening, as defined by International Prostate Symptom Score (IPSS) ≥13 * An IPSS QoL score of ≥3 at screening * Prostate specific antigen (PSA) at screening ≤10 ng/mL (responsibility of the Investigator to rule out prostate cancer when PSA is \>4 ng/mL, except in the USA where patients with a PSA \>4 and ≤10 ng/mL should undergo a prostatic biopsy or have a negative prostatic biopsy within 12 months prior to participation in the trial) * Maximum urinary flow (Qmax) ranging between 5 to 15 mL/second with a minimum voided volume \>125 mL at screening
Exclusion criteria
* Post void residual volume (PVR) \>250 mL * Stone in the bladder or urethra causing symptoms * Acute or chronic prostatitis * Interstitial cystitis / painful bladder syndrome * Acute or recurrent urinary tract infections * History of acute urinary retention (AUR) * Lower urinary tract instrumentation (including prostate biopsy) within 30 days of dosing at Visit 2 * Clinical evidence of any of the following urinary tract conditions: 1. Mullerian duct cysts 2. Atonic, decompensated, or hypocontractile bladder 3. Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation) * History of any of the following pelvic conditions: 1. Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or open lower colonic or rectal surgery 2. Pelvic radiotherapy 3. Any prior surgical procedure of the urinary tract, including minimally invasive LUTS/BPH therapies 4. Lower tract malignancy or trauma * Clinically significant microscopic haematuria at screening * History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance \<30 mL/minute at screening * Systolic blood pressure \>180 or \<90 mmHg or diastolic blood pressure \>110 or \<50 mmHg at screening or malignant hypertension * Any causes other than BPH, which may affect evaluation of symptoms of urine flow (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, and bladder malignancy) as judged by the Investigator * Use of any prohibited therapies * Elevated liver function tests at screening: 1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) \>2 times the upper limit of normal 2. Total bilirubin \>1.5 times the upper limit of normal * QTc interval on the screening ECG \>450 ms, or a family history of long QT syndrome * Any clinically significant disorder (other than BPH) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator * Diagnosed cancer within the last 5 years except for adequately managed basal cell carcinoma and squamous cell carcinoma of the skin * History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema * Mental incapacity or language barrier precluding adequate understanding or co-operation * History or current evidence of drug, alcohol, or substance abuse within 6 months prior to screening * Hypersensitivity towards any component of the investigational medicinal product (IMP) * Previous participation in any degarelix trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in International Prostate Symptom Score (IPSS) | From Baseline to Month 3 after Dosing | This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days. The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in IPSS | From Baseline to Month 4, Month 5 and Month 6 after Dosing | This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group. |
| Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | At Month 3, Month 4, Month 5 and Month 6 after Dosing | A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented. |
| Mean Percentage Change in Total Prostate Volume (TPV) | From Baseline to Month 3 and Month 6 after Dosing | TPV was measured directly by standardised trans-rectal ultrasound (TRUS). |
| Mean Change in Maximum Urinary Flow (Qmax) | From Baseline to Month 3 and Month 6 after Dosing | Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS). |
Countries
Belgium, Canada, Czechia, Italy, Poland, United States
Participant flow
Recruitment details
Patients who met the eligibility criteria were randomised in a 1:1:1:1 manner to 1 of the 4 treatment groups in this trial. The randomisation was stratified by region (North America and Europe) and prostate volume (\<30 mL and ≥30 mL). 404 patients were randomised and received a single dose of placebo, 10 mg, 20 mg, or 30 mg degarelix.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region. | 100 |
| Degarelix 10 mg Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region. | 101 |
| Degarelix 20 mg Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region. | 100 |
| Degarelix 30 mg Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region. | 102 |
| Total | 403 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 4 | 4 |
| Overall Study | Lost to Follow-up | 0 | 2 | 1 | 0 |
| Overall Study | Other/Unknown | 10 | 13 | 3 | 6 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 |
| Overall Study | Trial Terminated by Sponsor | 62 | 61 | 62 | 70 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 8 | 2 |
Baseline characteristics
| Characteristic | Degarelix 10 mg | Total | Degarelix 30 mg | Placebo | Degarelix 20 mg |
|---|---|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 7.89 | 65.3 years STANDARD_DEVIATION 7.59 | 65.4 years STANDARD_DEVIATION 7.56 | 65.2 years STANDARD_DEVIATION 7.86 | 65.7 years STANDARD_DEVIATION 7.12 |
| Baseline Body Mass Index (BMI) | 28.4 (kg/m^2) STANDARD_DEVIATION 3.93 | 28.2 (kg/m^2) STANDARD_DEVIATION 4.08 | 28.2 (kg/m^2) STANDARD_DEVIATION 4.81 | 28.5 (kg/m^2) STANDARD_DEVIATION 3.66 | 27.9 (kg/m^2) STANDARD_DEVIATION 3.84 |
| Baseline International Prostate Symptom Scores (IPSS) | 19.9 units on a scale STANDARD_DEVIATION 5.21 | 19.6 units on a scale STANDARD_DEVIATION 4.73 | 19.8 units on a scale STANDARD_DEVIATION 4.88 | 19.1 units on a scale STANDARD_DEVIATION 4.38 | 19.6 units on a scale STANDARD_DEVIATION 4.42 |
| Baseline Maximum Urinary Flow (Qmax) | 10.3 mL/sec STANDARD_DEVIATION 2.65 | 10.3 mL/sec STANDARD_DEVIATION 3.05 | 10.2 mL/sec STANDARD_DEVIATION 2.44 | 10.2 mL/sec STANDARD_DEVIATION 2.51 | 10.6 mL/sec STANDARD_DEVIATION 4.58 |
| Baseline Total Prostate Volume (TPV) | 42.9 mL STANDARD_DEVIATION 18.8 | 42.2 mL STANDARD_DEVIATION 19.2 | 42.1 mL STANDARD_DEVIATION 20.2 | 41.6 mL STANDARD_DEVIATION 17.8 | 42.3 mL STANDARD_DEVIATION 20.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 9 Participants | 4 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants | 394 Participants | 98 Participants | 99 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 13 Participants | 3 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 96 Participants | 384 Participants | 96 Participants | 96 Participants | 96 Participants |
| Region of Enrollment Europe | 41 participants | 163 participants | 42 participants | 41 participants | 39 participants |
| Region of Enrollment North America | 60 participants | 240 participants | 60 participants | 59 participants | 61 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 101 Participants | 403 Participants | 102 Participants | 100 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 98 | 35 / 101 | 39 / 100 | 56 / 105 |
| serious Total, serious adverse events | 2 / 98 | 8 / 101 | 2 / 100 | 7 / 105 |
Outcome results
Primary
Mean Change in International Prostate Symptom Score (IPSS)
This outcome measure was used to assess the dose-response of the 3 degarelix dose groups in terms of severity of lower urinary tract symptoms (LUTS) and progress of the disease process, versus the placebo group. One treatment month equals 28 days. The IPSS questionnaire is a tool commonly used to assess the severity of LUTS, and to monitor the progress of the symptoms during treatment. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. minimum total score is 0 and the maximum score is 35), where 0 corresponds to a response of not at all for the first six symptoms and none for nocturia, and 5 corresponds to a response of almost always for the first six symptoms and 5 times or more for nocturia. The IPSS also includes a question to evaluate a patient's quality of life in relation to his urinary symptoms, which is not included in the total IPSS score.
Time frame: From Baseline to Month 3 after Dosing
Population: FAS. The as planned patient allocation for treatment groups was used in the efficacy analyses (please refer to the Baseline Characteristics section).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change in International Prostate Symptom Score (IPSS) | -4.46 percentage change from baseline | Standard Deviation 5.34 |
| Degarelix 10 mg | Mean Change in International Prostate Symptom Score (IPSS) | -5.65 percentage change from baseline | Standard Deviation 6.03 |
| Degarelix 20 mg | Mean Change in International Prostate Symptom Score (IPSS) | -6.11 percentage change from baseline | Standard Deviation 5.7 |
| Degarelix 30 mg | Mean Change in International Prostate Symptom Score (IPSS) | -5.88 percentage change from baseline | Standard Deviation 5.97 |
Comparison: Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.0911Step-down, Williams' extended trend test
Comparison: Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.0865Step-down, Williams' extended trend test
Comparison: Analysis of Covariance (ANCOVA) of the change from baseline in IPSS at Month 3 in the FAS population using the Last Observation Carried Forward (LOCF) method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.2342Step-down, Williams' extended trend test
Secondary
Mean Change in IPSS
This secondary outcome measure was used to assess the maintained dose-response of the 3 degarelix dose groups in terms of severity of LUTS and progress of the disease process, versus the placebo group.
Time frame: From Baseline to Month 4, Month 5 and Month 6 after Dosing
Population: FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in IPSS | Mean Percentage Change at Month 6 | -4.3 percentage change from baseline | Standard Deviation 5.47 |
| Placebo | Mean Change in IPSS | Mean Percentage Change at Month 5 | -4.34 percentage change from baseline | Standard Deviation 5.94 |
| Placebo | Mean Change in IPSS | Mean Percentage Change at Month 4 | -4.12 percentage change from baseline | Standard Deviation 5.65 |
| Degarelix 10 mg | Mean Change in IPSS | Mean Percentage Change at Month 5 | -5.59 percentage change from baseline | Standard Deviation 6.89 |
| Degarelix 10 mg | Mean Change in IPSS | Mean Percentage Change at Month 4 | -5.52 percentage change from baseline | Standard Deviation 6.18 |
| Degarelix 10 mg | Mean Change in IPSS | Mean Percentage Change at Month 6 | -5.42 percentage change from baseline | Standard Deviation 6.7 |
| Degarelix 20 mg | Mean Change in IPSS | Mean Percentage Change at Month 4 | -6.3 percentage change from baseline | Standard Deviation 6.38 |
| Degarelix 20 mg | Mean Change in IPSS | Mean Percentage Change at Month 5 | -6.1 percentage change from baseline | Standard Deviation 6.46 |
| Degarelix 20 mg | Mean Change in IPSS | Mean Percentage Change at Month 6 | -5.72 percentage change from baseline | Standard Deviation 5.59 |
| Degarelix 30 mg | Mean Change in IPSS | Mean Percentage Change at Month 5 | -5.37 percentage change from baseline | Standard Deviation 5.97 |
| Degarelix 30 mg | Mean Change in IPSS | Mean Percentage Change at Month 6 | -5.62 percentage change from baseline | Standard Deviation 5.69 |
| Degarelix 30 mg | Mean Change in IPSS | Mean Percentage Change at Month 4 | -5.64 percentage change from baseline | Standard Deviation 5.6 |
Comparison: ANCOVA of the change from baseline in IPSS at Months 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.0367Step-down, Williams' extended trend test
Comparison: ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.0231Step-down, Williams' extended trend test
Comparison: ANCOVA of the change from baseline in IPSS at Month 4 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.1638Step-down, Williams' extended trend test
Comparison: ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.1941Step-down, Williams' extended trend test
Comparison: ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.1083Step-down, Williams' extended trend test
Comparison: ANCOVA of the change from baseline in IPSS at Month 5 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.2782Step-down, Williams' extended trend test
Comparison: ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.1562Step-down, Williams' extended trend test
Comparison: ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.1736Step-down, Williams' extended trend test
Comparison: ANCOVA of the change from baseline in IPSS at Month 6 in the FAS population using the LOCF method, including the baseline IPSS as adjusting covariate and treatment group, prostate volume stratum (\<30 mL and ≥30 mL), and region (North America and Europe) as factors.p-value: 0.3132Step-down, Williams' extended trend test
Secondary
Mean Change in Maximum Urinary Flow (Qmax)
Urinary flow rate (mL/second) was measured using uroflowmetry performed according to the recommendation from the International Continence Society (ICS).
Time frame: From Baseline to Month 3 and Month 6 after Dosing
Population: FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Maximum Urinary Flow (Qmax) | Mean Percentage Change at Month 3 | 0.652 percentage change from baseline | Standard Deviation 3.8 |
| Placebo | Mean Change in Maximum Urinary Flow (Qmax) | Mean Percentage Change at Month 6 | 1.04 percentage change from baseline | Standard Deviation 5.34 |
| Degarelix 10 mg | Mean Change in Maximum Urinary Flow (Qmax) | Mean Percentage Change at Month 6 | 0.516 percentage change from baseline | Standard Deviation 4.85 |
| Degarelix 10 mg | Mean Change in Maximum Urinary Flow (Qmax) | Mean Percentage Change at Month 3 | 0.564 percentage change from baseline | Standard Deviation 5.08 |
| Degarelix 20 mg | Mean Change in Maximum Urinary Flow (Qmax) | Mean Percentage Change at Month 3 | 0.626 percentage change from baseline | Standard Deviation 5.68 |
| Degarelix 20 mg | Mean Change in Maximum Urinary Flow (Qmax) | Mean Percentage Change at Month 6 | 0.582 percentage change from baseline | Standard Deviation 5.43 |
| Degarelix 30 mg | Mean Change in Maximum Urinary Flow (Qmax) | Mean Percentage Change at Month 3 | 0.723 percentage change from baseline | Standard Deviation 3.91 |
| Degarelix 30 mg | Mean Change in Maximum Urinary Flow (Qmax) | Mean Percentage Change at Month 6 | 1.43 percentage change from baseline | Standard Deviation 5.29 |
p-value: 0.851195% CI: [-1.068, 1.294]ANCOVA
p-value: 0.633195% CI: [-0.9, 1.477]ANCOVA
p-value: 0.90995% CI: [-1.113, 1.25]ANCOVA
p-value: 0.546995% CI: [-0.956, 1.802]ANCOVA
p-value: 0.790695% CI: [-1.576, 1.2]ANCOVA
p-value: 0.575795% CI: [-1.773, 0.987]ANCOVA
Secondary
Mean Percentage Change in Total Prostate Volume (TPV)
TPV was measured directly by standardised trans-rectal ultrasound (TRUS).
Time frame: From Baseline to Month 3 and Month 6 after Dosing
Population: FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Percentage Change in Total Prostate Volume (TPV) | Mean Percentage Change at Month 3 | 3.15 percentage change from baseline | Standard Deviation 23.3 |
| Placebo | Mean Percentage Change in Total Prostate Volume (TPV) | Mean Percentage Change at Month 6 | 3.96 percentage change from baseline | Standard Deviation 29.3 |
| Degarelix 10 mg | Mean Percentage Change in Total Prostate Volume (TPV) | Mean Percentage Change at Month 6 | 1.57 percentage change from baseline | Standard Deviation 31 |
| Degarelix 10 mg | Mean Percentage Change in Total Prostate Volume (TPV) | Mean Percentage Change at Month 3 | -1.46 percentage change from baseline | Standard Deviation 32.7 |
| Degarelix 20 mg | Mean Percentage Change in Total Prostate Volume (TPV) | Mean Percentage Change at Month 6 | 2.35 percentage change from baseline | Standard Deviation 26.5 |
| Degarelix 20 mg | Mean Percentage Change in Total Prostate Volume (TPV) | Mean Percentage Change at Month 3 | -0.252 percentage change from baseline | Standard Deviation 24.5 |
| Degarelix 30 mg | Mean Percentage Change in Total Prostate Volume (TPV) | Mean Percentage Change at Month 6 | -0.0112 percentage change from baseline | Standard Deviation 20.9 |
| Degarelix 30 mg | Mean Percentage Change in Total Prostate Volume (TPV) | Mean Percentage Change at Month 3 | 0.188 percentage change from baseline | Standard Deviation 24.4 |
p-value: 0.387695% CI: [-10.614, 4.128]ANCOVA
p-value: 0.254895% CI: [-11.65, 3.096]ANCOVA
p-value: 0.565295% CI: [-9.729, 5.322]ANCOVA
p-value: 0.750295% CI: [-8.768, 6.322]ANCOVA
p-value: 0.460795% CI: [-10.113, 4.59]ANCOVA
p-value: 0.608995% CI: [-9.513, 5.581]ANCOVA
Secondary
Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS
A 3-point reduction in IPSS score compared to baseline is defined as a clinically meaningful treatment response. Percentage of participants who met criteria for a clinically meaningful treatment response and odds ratios of treatment responses between each degarelix dose group and the placebo group are presented.
Time frame: At Month 3, Month 4, Month 5 and Month 6 after Dosing
Population: FAS. The as planned patient allocation for treatment groups was used (please refer to the Baseline Characteristics section).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 3) | 59.0 percentage of participants |
| Placebo | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 4) | 57.0 percentage of participants |
| Placebo | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 5) | 61.0 percentage of participants |
| Placebo | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 6) | 62.0 percentage of participants |
| Degarelix 10 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 4) | 65.3 percentage of participants |
| Degarelix 10 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 5) | 64.4 percentage of participants |
| Degarelix 10 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 6) | 68.3 percentage of participants |
| Degarelix 10 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 3) | 72.3 percentage of participants |
| Degarelix 20 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 5) | 66.0 percentage of participants |
| Degarelix 20 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 4) | 71.0 percentage of participants |
| Degarelix 20 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 6) | 67.0 percentage of participants |
| Degarelix 20 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 3) | 69.0 percentage of participants |
| Degarelix 30 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 6) | 71.6 percentage of participants |
| Degarelix 30 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 4) | 70.6 percentage of participants |
| Degarelix 30 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 3) | 68.6 percentage of participants |
| Degarelix 30 mg | Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS | 3-point reduction in IPSS vs. baseline (Month 5) | 67.6 percentage of participants |
p-value: 0.203495% CI: [0.814, 2.628]Regression, Logistic
p-value: 0.174895% CI: [0.834, 2.71]Regression, Logistic
p-value: 0.065895% CI: [0.964, 3.195]Regression, Logistic
p-value: 0.058795% CI: [0.979, 3.184]Regression, Logistic
p-value: 0.04995% CI: [1.003, 3.283]Regression, Logistic
p-value: 0.274295% CI: [0.774, 2.464]Regression, Logistic
p-value: 0.420695% CI: [0.706, 2.304]Regression, Logistic
p-value: 0.549495% CI: [0.664, 2.16]Regression, Logistic
p-value: 0.758695% CI: [0.609, 1.975]Regression, Logistic
p-value: 0.194695% CI: [0.816, 2.717]Regression, Logistic
p-value: 0.53895% CI: [0.667, 2.174]Regression, Logistic
p-value: 0.426395% CI: [0.702, 2.308]Regression, Logistic