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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-012325-11 | EudraCT Number | ||
| 104367 | Other Identifier | IND Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Degarelix 10 mg | Experimental |
| |
| Degarelix 20 mg | Experimental |
| |
| Degarelix 30 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Mannitol 50 mg/mL solution |
| |
| Degarelix 10 mg |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline to Month 3 after Dosing |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline to Month 4, Month 5 and Month 6 after Dosing |
| Odds Ratio (as Compared to Placebo) of Treatment Response in IPSS |
Not provided
Inclusion Criteria:
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:
History of any of the following pelvic conditions:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama, PC | Homewood | Alabama | United States | |||
| Coastal Clinical Research Inc |
Not provided
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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Not provided
| Drug |
10 mg degarelix, 40 mg/mL solution |
|
|
| Degarelix 20 mg | Drug | 20 mg degarelix, 40 mg/mL solution |
|
|
| Degarelix 30 mg | Drug | 30 mg degarelix, 40 mg/mL solution |
|
|
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. |
| At Month 3, Month 4, Month 5 and Month 6 after Dosing |
| Mean Percentage Change in Total Prostate Volume (TPV) | TPV was measured directly by standardised trans-rectal ultrasound (TRUS). | From Baseline to Month 3 and Month 6 after Dosing |
| 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). | From Baseline to Month 3 and Month 6 after Dosing |
| Mobile |
| Alabama |
| United States |
| California Professional Research | Newport Beach | California | United States |
| Genitourinary Surgical Consultants | Denver | Colorado | United States |
| Urology Associates , PC | Englewood | Colorado | United States |
| South Florida Medical Research | Aventura | Florida | United States |
| Winter Park Urology Associates | Orlando | Florida | United States |
| Pinellas Urology Inc | St. Petersburg | Florida | United States |
| Florida Urology Partners | Tampa | Florida | United States |
| Northwestern University | Chicago | Illinois | United States |
| Weill Cornell Medical College New York Presbyterian | New York | New York | United States |
| Hudson Valley Urology, PC | Poughkeepsie | New York | United States |
| Duke University Medical Center | Durham | North Carolina | United States |
| Patient Priority Clinical Sites, LLC | Cincinnati | Ohio | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | United States |
| Middelheim Antwerp | Antwerp | Belgium |
| UZ Brussel | Brussels | Belgium |
| Can-Med Clinical Research Inc | Victoria | British Columbia | Canada |
| Dr Steinhoff Clinical Research | Victoria | British Columbia | Canada |
| Male/Female Health and Research Centre | Barrie | Ontario | Canada |
| Bramalea Medical Centre | Brampton | Ontario | Canada |
| Brandford Urology Research | Brantford | Ontario | Canada |
| Guelp Urology | Guelph | Ontario | Canada |
| Centre for Applied Urological Research | Kingston | Ontario | Canada |
| Investigational Site | North Bay | Ontario | Canada |
| Female/Male Health Centres | Oakville | Ontario | Canada |
| Mahoney Medicine Professional Corporation | Ottawa | Ontario | Canada |
| Todd Webster Ontario Inc | Owen Sound | Ontario | Canada |
| Anthony Skehan Medicine Professional Corporation | Thunder Bay | Ontario | Canada |
| The Male Health Centre | Toronto | Ontario | Canada |
| McGill University Health Centre | Montreal | Quebec | Canada |
| Ultra-Med Inc | Point-Claire | Quebec | Canada |
| Urologie, Male namesti 1783 | Benešov | Czechia |
| Urocentrum Brno, Purkynova 35e | Brno | Czechia |
| Prvni privatni chirurgicke centrum SANUS, Labská kotlina I/1220 | Hradec Králové | Czechia |
| Urologicka ambulance, Litomerice (Halek) | Litoměřice | Czechia |
| Slezska nemocnice, prospevkova organizace, Urologicke oddeleni | Opava | Czechia |
| Androgeos - soukrome urologicke a andrologicke cen, Na valech 4/289 | Prague | Czechia |
| Urocentrum, Karlovo namesti 3 | Prague | Czechia |
| Urologica ambulance, Praha 10 | Prague | Czechia |
| Ústecké urocentrum, Ústi nad Labem (Liehne) | Ústi Nad Labem | Czechia |
| Urologia, A.O. San Giuseppe Moscati, Avellino | Avellino | Italy |
| Unità Operativa di Urologia, Azienda Opsedaliera Luigi Sacco | Milan | Italy |
| Unità Operativa di Urologia, Ospedale San Raffaele | Milan | Italy |
| Akademia Medyczna w Gdansku | Gdansk | Poland |
| Publiczny Specjalistyczny ZOZ | Inowrocław | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr.1 | Zabrze | Poland |
| FG002 | 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. |
| FG003 | 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. |
| Full Analysis Set (FAS) |
|
| Actual Treatment |
|
| Safety Analysis Set |
|
| Visit 12, Month 6 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
FAS. The efficacy analyses were based on the "as planned" treatment. Three patients deviated from the planned dosing and were included in the planned treatment groups in the FAS (i.e. not in the actual treatment groups as for the Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Body Mass Index (BMI) | Mean | Standard Deviation | (kg/m^2) |
| |||||||||||||||
| Baseline International Prostate Symptom Scores (IPSS) | The IPSS questionnaire was used to assess the severity of Lower Urinary Tract Symptoms (LUTS). A detailed description of the questionnaire is provided in the Primary Outcome Measure section. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline Total Prostate Volume (TPV) | TPV was measured directly by Trans-Rectal Ultrasound (TRUS). | Mean | Standard Deviation | mL |
| ||||||||||||||
| Baseline Maximum Urinary Flow (Qmax) | Uroflowmetry was used according to International Continence Society (ICS) recommendation. | Mean | Standard Deviation | mL/sec |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | FAS. The "as planned" patient allocation for treatment groups was used in the efficacy analyses (please refer to the Baseline Characteristics section). | Posted | Mean | Standard Deviation | percentage change from baseline | From Baseline to Month 3 after Dosing |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS. The "as planned" patient allocation for treatment groups was used (please refer to the Baseline Characteristics section). | Posted | Mean | Standard Deviation | percentage change from baseline | From Baseline to Month 4, Month 5 and Month 6 after Dosing |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | FAS. The "as planned" patient allocation for treatment groups was used (please refer to the Baseline Characteristics section). | Posted | Number | percentage of participants | At Month 3, Month 4, Month 5 and Month 6 after Dosing |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percentage Change in Total Prostate Volume (TPV) | TPV was measured directly by standardised trans-rectal ultrasound (TRUS). | FAS. The "as planned" patient allocation for treatment groups was used (please refer to the Baseline Characteristics section). | Posted | Mean | Standard Deviation | percentage change from baseline | From Baseline to Month 3 and Month 6 after Dosing |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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). | FAS. The "as planned" patient allocation for treatment groups was used (please refer to the Baseline Characteristics section). | Posted | Mean | Standard Deviation | percentage change from baseline | From Baseline to Month 3 and Month 6 after Dosing |
|
This was a single dose trial and adverse events were recorded from signed informed consent up to a maximum of 12 months after the dose. However, the trial was stopped when all patients had completed the visit scheduled 6 months after the dosing.
Adverse events were evaluated at each visit. The safety analyses were based on the actual treatment. Three patients did not receive their randomised treatment: 2 patients randomised to placebo received 30 mg, and 1 patient randomised to 20 mg received 30 mg degarelix. They were included in the actual treatment group in the safety analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region. | 2 | 98 | 31 | 98 | ||
| EG001 | 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. | 8 | 101 | 35 | 101 | ||
| EG002 | 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. | 2 | 100 | 39 | 100 | ||
| EG003 | 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. | 7 | 105 | 56 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Abscess intestinal | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment |
| |
| Coagulation time prolonged | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Adenosquamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment |
| |
| Carotid sinus syndrome | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA (12.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment |
|
Following the planned 6-month interim analysis when all patients had completed the visit scheduled 6 months after dosing, a decision was taken to stop the trial since the primary efficacy endpoint was not met.
The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Europe |
|
Treatment difference between "Degarelix 30 mg" and "Placebo" at Month 3.
| No |
| Superiority or Other |
| 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. | Step-down, Williams' extended trend test | Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate. | 0.0865 | P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made. | Mean Difference (Final Values) | -1.44 | 2-Sided | Treatment difference between "Degarelix 20 mg" and "Placebo" at Month 3. | No | Superiority or Other |
| 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. | Step-down, Williams' extended trend test | Step-down procedure (starting with 30 mg vs. placebo) to identify the minimum effective dose. The step-down testing protects the type I error rate. | 0.2342 | P-value based on Williams' extended trend test of comparison vs. placebo at Month 3. No adjustment for multiple comparisons was made. | Mean Difference (Final Values) | -0.92 | Treatment difference between "Degarelix 10 mg" and "Placebo" at Month 3. | No | Superiority or Other |
Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
|
|
|
| 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. |
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