Prostatic Hyperplasia
Conditions
Keywords
Combination Therapy, dutasteride, BPH
Brief summary
This study will investigate the efficacy and safety of treatment with dutasteride and tamsulosin, administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic Benign Prostatic Hyperplasia (BPH). Study visits are every 3 months for up to 4 years (18 clinic visits). Transrectal ultrasound (TRUS) is done annually.
Detailed description
A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5 mg) and Tamsulosin (0.4 mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia.
Interventions
DRUGdutasteride 0.5mg once daily for 4 years
combination or single agent
DRUGtamsulosin 0.4mg once daily for 4 years
combination agent or single agent
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A subject will be considered eligible for inclusion in this study only if all of the following criteria apply: * males, aged ≥50 years * clinical diagnosis of BPH by medical history and physical examination, including a digital rectal examination (DRE) * International Prostate Symptom Score (IPSS) ≥12 points at Screening * prostate volume ≥30 cc by transrectal ultrasonography; (TRUS) * total serum Prostate Specific Antigen (PSA) ≥1.5ng/mL at Screening * maximum flow rate (Qmax) \>5 mL/sec and ≤15 mL/sec and minimum voided volume of ≥125 mL at Screening (based on two voids) * willing and able to give written informed consent and comply with study procedures * fluent and literate in local language with the ability to read, comprehend and record information on the IPSS, BII and Patient Perception of Study Medication * able to swallow and retain oral medication * willing and able to participate in the study for the full 4 years.
Exclusion criteria
A subject will not be eligible for inclusion in this study if any of the following criteria apply: * total serum PSA \>10.0ng/mL at Screening * history or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious DRE). Patients with suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6 months and stable PSA are eligible for the study. Note: If total serum PSA is \>4ng/mL and unless PSA value has been stable for at least the past 2 years, the investigator should make every appropriate effort to exclude the possibility of prostate cancer, e.g. further DRE, review TRUS taken within previous month, consider 8-12 core prostate biopsy in accordance with routine clinical practice. * previous prostatic surgery (including TURP, balloon dilatation, thermotherapy and stent replacement) or other invasive procedures to treat BPH. * history of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days prior to the Screening Visit. Routine catheterisation is acceptable with no time restriction. * history of AUR within 3 months prior to Screening Visit. * post-void residual volume \>250mL (suprapubic ultrasound) at Screening. * any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate (e.g. neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, or acute or chronic urinary tract infections). * history of breast cancer or clinical breast examination finding of unclear origin or suggestive of malignancy. * use of any 5-alpha-reductase inhibitor (e.g. Proscar®, Propecia®, Avodart®), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, metronidazole, progestational agents), or other drugs which affect prostate volume, within past 6 months of the Screening Visit and throughout the study (other than as study medication). * concurrent use of anabolic steroids * use of phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study. * use of any alpha-adrenoreceptor blockers (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin and doxazosin) within 2 weeks of Screening Visit and/or predicted to need any alpha blockers other than tamsulosin during the study. Note: the purpose of this criteria is to be able to standardise baseline symptom severity for all enrolled patients prior to randomisation and not to specifically exclude current alpha-adrenoreceptor blocker users from participation in the study. * use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephrine, ephedrine) or anticholinergics (e.g. oxybutynin, propantheline) or cholinergics (e.g. bethanecol chloride) within 48 hours prior to all uroflowmetry assessments. * hypersensitivity to any alpha-/beta- adrenoreceptor blocker or 5-alpha-reductase inhibitor, or other chemically-related drugs. * concurrent use of drugs known or thought to have an interaction with tamsulosin, e.g. cimetidine and warfarin. * history of hepatic impairment or abnormal liver function tests at Screening defined as alanine aminotransferase (ALT), aspartate aminotranferase (AST), and/or alkaline phosphatase \>2 times the upper limit of normal, or total bilirubin \>1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin elevation or Gilbert's syndrome). * history of renal insufficiency, or serum creatinine \>1.5 times the upper limit of normal or serum creatinine ≥1.5 mg/dL at Screening. * prior history of malignancies other than basal cell carcinoma or squamous cell carcinoma of the skin within the past 5 years. Subjects with a prior malignancy who have had no evidence of disease for at least the past 5 years are eligible. * history of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient. * any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management. * history of postural hypotension, dizziness, vertigo or any other signs and symptoms of orthostasis, which in the opinion of the investigator could be exacerbated by tamsulosin and result in putting the subject at risk of injury. * history of unsuccessful treatment with tamsulosin or 'first dose' hypotensive episode on initiation of alpha-1-adrenoreceptor antagonist therapy. * history of unsuccessful treatment with finasteride or dutasteride * history or current evidence of drug or alcohol abuse within the previous 12 months. * participation in any investigational or marketed drug trial within 30 days (or 5 half-lives whichever is the longer) preceding the Screening Visit and/or during the course of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Years 1, 2, 3, and 4 | A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record. |
| Number of Participants With AUR or BPH-related Surgery | Baseline (Day 1) through Year 4 | A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Events of Symptom Deterioration at the Indicated Time Periods | Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit) | The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35). |
| Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Baseline (Day 1) through Year 4 | A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories. |
| Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Baseline (Day 1) through Year 4 | A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories. |
| Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS. |
| Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax. |
| Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = \[(post-baseline - baseline)/baseline value\] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline. |
| Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = \[(post-BL - BL)/BL value\] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL. |
| Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Every 3 months from Month 3 to Month 48 | At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit? If the answer to the question was yes, the number of visits was recorded. |
| Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Every 3 months from Month 3 to Month 48 | At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?. If the answer to the question was yes, the number of Yes responses was recorded. |
| Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Every 3 months from Month 3 to Month 48 | At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was yes, the number of visits was recorded. |
| Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Every 3 months from Month 3 to Month 48 | At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was yes, the number of Yes responses was recorded. |
| Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Every 3 months from Month 3 to Month 48 | At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?. If the answer to the question was yes, the number of visits was recorded. |
| Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Every 3 months from Month 3 to Month 48 | At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?. If the answer to the question was yes, the number of visits was recorded. |
| Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Years 1, 2, 3, and 4 | The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond. |
| Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, 48 | The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = \[(post-baseline - baseline)/baseline value\] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has control of your urinary problems changed?. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on control of your urinary problems? Satisfact., satisfaction. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the strength of your urinary stream changed?. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on the strength of your urinary stream?. Satisfact., satisfaction. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain prior to urinating changed?. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain prior to urinating?. Satisfact., satisfaction. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain during urination changed?. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain during urination?. Satisfact., satisfaction. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?. Satisfact., satisfaction. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Overall, how satisfied are you with the study medication and it's effect on your urinary problems?. Satisfact., satisfaction. |
| Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Baseline and Months 12, 24, 36, and 48 | This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Would you ask your doctor for the medication you received in this study?. |
| Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII. |
| The Number of Participants With Each of the Five Components of BPH Clinical Progression | Baseline (Day 1) to Year 4 | The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency. |
Countries
Argentina, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Israel, Italy, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Tunisia, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
In a 4-week, single-blind placebo run-in period, all participants (par.) took two capsules consisting of one dutasteride-matched placebo capsule and one tamsulosin-matched placebo capsule once daily for 4 weeks. A safety follow-up was performed for all participants 16 weeks after the last dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks | 1,610 |
| Dutasteride 0.5 mg Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks | 1,623 |
| Tamsulosin 0.4 mg Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks | 1,611 |
| Total | 4,844 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 16-Week Safety Follow-up Period | Acute Urinary Retention (AUR) | 0 | 5 | 4 |
| 16-Week Safety Follow-up Period | Adverse Event | 34 | 39 | 44 |
| 16-Week Safety Follow-up Period | Alcohol Dependent | 1 | 0 | 1 |
| 16-Week Safety Follow-up Period | Angina Pectoris | 0 | 1 | 0 |
| 16-Week Safety Follow-up Period | Back Pain | 0 | 1 | 0 |
| 16-Week Safety Follow-up Period | BPH/BPH symptoms worse/urinary incont. | 0 | 2 | 3 |
| 16-Week Safety Follow-up Period | Death | 1 | 0 | 1 |
| 16-Week Safety Follow-up Period | Depression | 0 | 1 | 0 |
| 16-Week Safety Follow-up Period | Diabetes Uncontrolled | 0 | 1 | 0 |
| 16-Week Safety Follow-up Period | Disease Progression/Treatment Failure | 3 | 1 | 1 |
| 16-Week Safety Follow-up Period | Enrollment Error | 1 | 0 | 2 |
| 16-Week Safety Follow-up Period | Gyneomastia | 1 | 0 | 0 |
| 16-Week Safety Follow-up Period | Investigator/Sponsor Decision | 0 | 2 | 3 |
| 16-Week Safety Follow-up Period | Jailed | 0 | 1 | 0 |
| 16-Week Safety Follow-up Period | Loss of Contact | 4 | 0 | 2 |
| 16-Week Safety Follow-up Period | Loss of Libido | 1 | 0 | 0 |
| 16-Week Safety Follow-up Period | Lost to Follow-up | 101 | 97 | 111 |
| 16-Week Safety Follow-up Period | Neoplasm of Bladder/Prostate Cancer | 1 | 3 | 6 |
| 16-Week Safety Follow-up Period | Non-compliant/Medication Interruption | 8 | 6 | 4 |
| 16-Week Safety Follow-up Period | Other | 0 | 1 | 0 |
| 16-Week Safety Follow-up Period | Participant Decision/Withdrawn | 2 | 1 | 2 |
| 16-Week Safety Follow-up Period | Participant relocated | 2 | 3 | 1 |
| 16-Week Safety Follow-up Period | Prohibited Medication | 2 | 3 | 5 |
| 16-Week Safety Follow-up Period | Prostate surgery/TURP/Alt. therapy | 1 | 5 | 13 |
| 16-Week Safety Follow-up Period | Protocol Violation | 18 | 18 | 17 |
| 16-Week Safety Follow-up Period | Scheduling Issues | 0 | 2 | 4 |
| 16-Week Safety Follow-up Period | Site Closed/Sponsor Termination | 8 | 5 | 4 |
| 16-Week Safety Follow-up Period | Withdrawal by Subject | 185 | 212 | 229 |
| Four-Year Double-Blind Treatment Period | Acute Urinary Retention (AUR) | 2 | 3 | 6 |
| Four-Year Double-Blind Treatment Period | Adverse Event | 211 | 185 | 210 |
| Four-Year Double-Blind Treatment Period | Alcohol Dependent | 1 | 0 | 0 |
| Four-Year Double-Blind Treatment Period | Angina Pectoris | 0 | 2 | 0 |
| Four-Year Double-Blind Treatment Period | Any Appreciable Improvement | 0 | 1 | 0 |
| Four-Year Double-Blind Treatment Period | Back Pain | 0 | 1 | 0 |
| Four-Year Double-Blind Treatment Period | BPH/BPH symptoms worse/urinary incont. | 1 | 0 | 5 |
| Four-Year Double-Blind Treatment Period | Cardiologist/Neurologist Decision | 0 | 2 | 0 |
| Four-Year Double-Blind Treatment Period | Enrollment Error | 0 | 0 | 2 |
| Four-Year Double-Blind Treatment Period | Financial Problems | 1 | 0 | 0 |
| Four-Year Double-Blind Treatment Period | Investigator Decision | 0 | 1 | 3 |
| Four-Year Double-Blind Treatment Period | Investigator Departure | 2 | 0 | 0 |
| Four-Year Double-Blind Treatment Period | Lack of Efficacy | 53 | 71 | 104 |
| Four-Year Double-Blind Treatment Period | Loss of Contact | 0 | 1 | 0 |
| Four-Year Double-Blind Treatment Period | Loss of Libido | 1 | 0 | 0 |
| Four-Year Double-Blind Treatment Period | Lost to Follow-up | 53 | 48 | 58 |
| Four-Year Double-Blind Treatment Period | Neoplasm of Bladder/Prostate | 0 | 1 | 1 |
| Four-Year Double-Blind Treatment Period | No Improvement | 1 | 0 | 0 |
| Four-Year Double-Blind Treatment Period | Non-compliant/Medication Interruption | 6 | 4 | 7 |
| Four-Year Double-Blind Treatment Period | Participant Decision/Withdrawn | 2 | 0 | 4 |
| Four-Year Double-Blind Treatment Period | Participant Relocated | 7 | 2 | 8 |
| Four-Year Double-Blind Treatment Period | Prohibited Medication | 2 | 2 | 8 |
| Four-Year Double-Blind Treatment Period | Prostate Specific Antigen Rising | 0 | 1 | 0 |
| Four-Year Double-Blind Treatment Period | Prostate Surgery/TURP/Alt. Therapy | 3 | 7 | 19 |
| Four-Year Double-Blind Treatment Period | Protocol Violation | 29 | 29 | 34 |
| Four-Year Double-Blind Treatment Period | Renal Insufficiency | 0 | 1 | 0 |
| Four-Year Double-Blind Treatment Period | Scheduling Issues | 0 | 1 | 0 |
| Four-Year Double-Blind Treatment Period | Screen Failure | 1 | 0 | 0 |
| Four-Year Double-Blind Treatment Period | Site Closed/Sponsor Termination | 7 | 7 | 4 |
| Four-Year Double-Blind Treatment Period | Urinary Tract Infection (UTI) | 0 | 0 | 1 |
| Four-Year Double-Blind Treatment Period | Withdrawal by Subject | 114 | 160 | 148 |
Baseline characteristics
| Characteristic | Total | Tamsulosin 0.4 mg | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Dutasteride 0.5 mg |
|---|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 7.01 | 66.2 years STANDARD_DEVIATION 7 | 66.0 years STANDARD_DEVIATION 7.05 | 66.0 years STANDARD_DEVIATION 6.99 |
| Gender Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Gender Male | 4844 Participants | 1611 Participants | 1610 Participants | 1623 Participants |
| Race/Ethnicity, Customized American Hispanic | 147 participants | 55 participants | 44 participants | 48 participants |
| Race/Ethnicity, Customized Asian | 325 participants | 112 participants | 107 participants | 106 participants |
| Race/Ethnicity, Customized Black | 63 participants | 24 participants | 22 participants | 17 participants |
| Race/Ethnicity, Customized Unknown | 50 participants | 15 participants | 16 participants | 19 participants |
| Race/Ethnicity, Customized White | 4259 participants | 1405 participants | 1421 participants | 1433 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 618 / 1,610 | 586 / 1,623 | 590 / 1,611 |
| serious Total, serious adverse events | 303 / 1,610 | 339 / 1,623 | 348 / 1,611 |
Outcome results
Primary
Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.
Time frame: Years 1, 2, 3, and 4
Population: Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 2, n=1457, 1484, 1464 | 14 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 3, n=1347, 1365, 1307 | 15 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 4, n=1274, 1277, 1176 | 9 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 1, n=1610, 1623, 1611 | 29 events |
| Dutasteride 0.5 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 1, n=1610, 1623, 1611 | 27 events |
| Dutasteride 0.5 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 2, n=1457, 1484, 1464 | 22 events |
| Dutasteride 0.5 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 4, n=1274, 1277, 1176 | 19 events |
| Dutasteride 0.5 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 3, n=1347, 1365, 1307 | 16 events |
| Tamsulosin 0.4 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 1, n=1610, 1623, 1611 | 40 events |
| Tamsulosin 0.4 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 3, n=1347, 1365, 1307 | 44 events |
| Tamsulosin 0.4 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 4, n=1274, 1277, 1176 | 45 events |
| Tamsulosin 0.4 mg | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Year 2, n=1457, 1484, 1464 | 62 events |
p-value: 0.1895% CI: [0.58, 1.11]Log Rank
p-value: <0.00195% CI: [0.26, 0.45]Log Rank
Primary
Number of Participants With AUR or BPH-related Surgery
A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.
Time frame: Baseline (Day 1) through Year 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Participants With AUR or BPH-related Surgery | AUR | 35 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Participants With AUR or BPH-related Surgery | BPH-related surgery | 32 participants |
| Dutasteride 0.5 mg | Number of Participants With AUR or BPH-related Surgery | AUR | 44 participants |
| Dutasteride 0.5 mg | Number of Participants With AUR or BPH-related Surgery | BPH-related surgery | 40 participants |
| Tamsulosin 0.4 mg | Number of Participants With AUR or BPH-related Surgery | AUR | 109 participants |
| Tamsulosin 0.4 mg | Number of Participants With AUR or BPH-related Surgery | BPH-related surgery | 82 participants |
p-value: 0.18Log Rank
p-value: <0.001Log Rank
Secondary
Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48
The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 24 | -2.1 points on a scale | Standard Error 0.07 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 12 | -1.9 points on a scale | Standard Error 0.06 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 36 | -2.2 points on a scale | Standard Error 0.07 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 48 | -2.2 points on a scale | Standard Error 0.07 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 48 | -1.8 points on a scale | Standard Error 0.07 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 36 | -1.8 points on a scale | Standard Error 0.07 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 12 | -1.5 points on a scale | Standard Error 0.06 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 24 | -1.7 points on a scale | Standard Error 0.07 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 12 | -1.6 points on a scale | Standard Error 0.06 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 24 | -1.5 points on a scale | Standard Error 0.07 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 36 | -1.3 points on a scale | Standard Error 0.07 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48 | Month 48 | -1.2 points on a scale | Standard Error 0.07 |
Secondary
Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48
The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = \[(post-baseline - baseline)/baseline value\] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.
Time frame: Baseline and Months 12, 24, 36, 48
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 12 | -1.2 points on a scale | Standard Error 0.03 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 24 | -1.4 points on a scale | Standard Error 0.03 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 36 | -1.5 points on a scale | Standard Error 0.03 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 48 | -1.5 points on a scale | Standard Error 0.03 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 48 | -1.3 points on a scale | Standard Error 0.03 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 12 | -1.0 points on a scale | Standard Error 0.03 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 36 | -1.2 points on a scale | Standard Error 0.03 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 24 | -1.1 points on a scale | Standard Error 0.03 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 48 | -1.1 points on a scale | Standard Error 0.03 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 24 | -1.1 points on a scale | Standard Error 0.03 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 36 | -1.1 points on a scale | Standard Error 0.03 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48 | Month 12 | -1.0 points on a scale | Standard Error 0.03 |
Secondary
Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48
The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 48 | -6.3 points on a scale | Standard Error 0.16 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 24 | -6.2 points on a scale | Standard Error 0.15 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 36 | -6.3 points on a scale | Standard Error 0.16 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 12 | -5.6 points on a scale | Standard Error 0.15 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 24 | -4.9 points on a scale | Standard Error 0.15 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 36 | -5.2 points on a scale | Standard Error 0.16 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 12 | -4.2 points on a scale | Standard Error 0.15 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 48 | -5.3 points on a scale | Standard Error 0.16 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 36 | -4.0 points on a scale | Standard Error 0.16 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 24 | -4.3 points on a scale | Standard Error 0.15 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 48 | -3.8 points on a scale | Standard Error 0.16 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Month 12 | -4.5 points on a scale | Standard Error 0.15 |
Secondary
Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48
Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = \[(post-BL - BL)/BL value\] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Transition zone measurements were only done on a subset of participants at sites with experience in measuring the transition zone of the prostate. Also, transition zone measurements were either not performed or missing for some participants at various timepoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 24, n= 153, 164, 160 | -23.4 percent change | Standard Error 5.63 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 36, n= 155, 164, 162 | -20.9 percent change | Standard Error 3.97 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 12, n= 150, 159, 160 | -17.2 percent change | Standard Error 3.29 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 48, n= 155, 164, 163 | -17.9 percent change | Standard Error 4.45 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 36, n= 155, 164, 162 | -26.7 percent change | Standard Error 3.9 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 12, n= 150, 159, 160 | -15.6 percent change | Standard Error 3.39 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 24, n= 153, 164, 160 | -22.8 percent change | Standard Error 5.86 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 48, n= 155, 164, 163 | -26.5 percent change | Standard Error 4.21 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 24, n= 153, 164, 160 | 8.7 percent change | Standard Error 8.22 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 12, n= 150, 159, 160 | 5.6 percent change | Standard Error 4.09 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 48, n= 155, 164, 163 | 18.2 percent change | Standard Error 6.54 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48 | Month 36, n= 155, 164, 162 | 14.7 percent change | Standard Error 5.89 |
Secondary
Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48
Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Also, assessments with voided volumes \<125 ml were not included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 12, n=1477, 1482, 1510 | 2.0 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 48, n= 1495, 1505, 1523 | 2.4 milliliters (mL)/second (sec) | Standard Error 0.13 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 36, n= 1495, 1504, 1521 | 2.6 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 24, n= 1492, 1501, 1519 | 2.4 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 48, n= 1495, 1505, 1523 | 2.0 milliliters (mL)/second (sec) | Standard Error 0.13 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 12, n=1477, 1482, 1510 | 1.5 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 24, n= 1492, 1501, 1519 | 1.9 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Dutasteride 0.5 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 36, n= 1495, 1504, 1521 | 1.9 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 36, n= 1495, 1504, 1521 | 0.6 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 12, n=1477, 1482, 1510 | 0.9 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 24, n= 1492, 1501, 1519 | 0.9 milliliters (mL)/second (sec) | Standard Error 0.12 |
| Tamsulosin 0.4 mg | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Month 48, n= 1495, 1505, 1523 | 0.7 milliliters (mL)/second (sec) | Standard Error 0.13 |
Secondary
Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48
Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = \[(post-baseline - baseline)/baseline value\] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Also, prostate measurements were either not performed or missing for some participants at various timepoints.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 12, n=1411, 1442, 1451 | -24.1 percent change | Standard Error 0.6 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 36, n= 1430, 1455, 1468 | -27.6 percent change | Standard Error 0.68 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 24, n= 1427, 1451, 1465 | -26.9 percent change | Standard Error 0.62 |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 48, n= 1430, 1455, 1468 | -27.3 percent change | Standard Error 0.66 |
| Dutasteride 0.5 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 12, n=1411, 1442, 1451 | -25.2 percent change | Standard Error 0.59 |
| Dutasteride 0.5 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 48, n= 1430, 1455, 1468 | -28.0 percent change | Standard Error 0.65 |
| Dutasteride 0.5 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 36, n= 1430, 1455, 1468 | -28.8 percent change | Standard Error 0.66 |
| Dutasteride 0.5 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 24, n= 1427, 1451, 1465 | -28.0 percent change | Standard Error 0.61 |
| Tamsulosin 0.4 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 24, n= 1427, 1451, 1465 | 0.0 percent change | Standard Error 0.84 |
| Tamsulosin 0.4 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 36, n= 1430, 1455, 1468 | 1.6 percent change | Standard Error 0.94 |
| Tamsulosin 0.4 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 48, n= 1430, 1455, 1468 | 4.6 percent change | Standard Error 0.94 |
| Tamsulosin 0.4 mg | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Month 12, n=1411, 1442, 1451 | -1.5 percent change | Standard Error 0.77 |
Secondary
Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4
The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.
Time frame: Years 1, 2, 3, and 4
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 1, n=1610, 1623, 1611 | 126 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 2, n= 1264, 1240, 1262 | 31 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 3, n=1135, 1082, 1048 | 30 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 4, n= 1047, 959, 880 | 16 events |
| Dutasteride 0.5 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 4, n= 1047, 959, 880 | 22 events |
| Dutasteride 0.5 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 1, n=1610, 1623, 1611 | 184 events |
| Dutasteride 0.5 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 3, n=1135, 1082, 1048 | 29 events |
| Dutasteride 0.5 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 2, n= 1264, 1240, 1262 | 54 events |
| Tamsulosin 0.4 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 4, n= 1047, 959, 880 | 31 events |
| Tamsulosin 0.4 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 2, n= 1264, 1240, 1262 | 78 events |
| Tamsulosin 0.4 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 3, n=1135, 1082, 1048 | 67 events |
| Tamsulosin 0.4 mg | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Year 1, n=1610, 1623, 1611 | 171 events |
Secondary
Number of Events of Symptom Deterioration at the Indicated Time Periods
The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).
Time frame: Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)
Population: Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 1, n=1610, 1623, 1611 | 91 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 2, n=1286, 1278, 1296 | 23 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 3, n=1158, 1132, 1088 | 14 events |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 4, n=1083, 1001, 926 | 11 events |
| Dutasteride 0.5 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 4, n=1083, 1001, 926 | 13 events |
| Dutasteride 0.5 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 1, n=1610, 1623, 1611 | 138 events |
| Dutasteride 0.5 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 3, n=1158, 1132, 1088 | 23 events |
| Dutasteride 0.5 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 2, n=1286, 1278, 1296 | 38 events |
| Tamsulosin 0.4 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 4, n=1083, 1001, 926 | 19 events |
| Tamsulosin 0.4 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 2, n=1286, 1278, 1296 | 49 events |
| Tamsulosin 0.4 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 3, n=1158, 1132, 1088 | 42 events |
| Tamsulosin 0.4 mg | Number of Events of Symptom Deterioration at the Indicated Time Periods | Year 1, n=1610, 1623, 1611 | 119 events |
p-value: <0.00195% CI: [0.52, 0.8]Log Rank
p-value: <0.00195% CI: [0.48, 0.72]Log Rank
Secondary
Number of Participants With an Event of Post-baseline BPH-related Hematospermia
A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.
Time frame: Baseline (Day 1) through Year 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Non-BPH-related Crude Rate | 2 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Overall Crude Rate | 18 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | BPH-related Crude Rate | 17 participants |
| Dutasteride 0.5 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Non-BPH-related Crude Rate | 3 participants |
| Dutasteride 0.5 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Overall Crude Rate | 19 participants |
| Dutasteride 0.5 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | BPH-related Crude Rate | 17 participants |
| Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Overall Crude Rate | 20 participants |
| Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | BPH-related Crude Rate | 11 participants |
| Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Non-BPH-related Crude Rate | 9 participants |
p-value: 0.95Log Rank
p-value: 0.24Log Rank
Secondary
Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria
A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.
Time frame: Baseline (Day 1) through Year 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Non-BPH-related Crude Rate | 15 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Overall crude rate | 53 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | BPH-Related Crude Rate | 40 participants |
| Dutasteride 0.5 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Non-BPH-related Crude Rate | 28 participants |
| Dutasteride 0.5 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Overall crude rate | 70 participants |
| Dutasteride 0.5 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | BPH-Related Crude Rate | 45 participants |
| Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Overall crude rate | 81 participants |
| Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | BPH-Related Crude Rate | 56 participants |
| Tamsulosin 0.4 mg | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Non-BPH-related Crude Rate | 25 participants |
p-value: 0.65Log Rank
p-value: 0.1Log Rank
Secondary
Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?. If the answer to the question was yes, the number of visits was recorded.
Time frame: Every 3 months from Month 3 to Month 48
Population: ITT Population. As study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 15, n=1343, 1386, 1380 | 24 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 6, n=1479, 1517, 1514 | 23 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 9, n=1439, 1465, 1477 | 16 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 12, n=1400, 1431, 1434 | 30 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 3, n=1550, 1581, 1564 | 23 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 18, n=1318, 1350, 1328 | 21 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 21, n=1281, 1326, 1287 | 18 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 24, n=1263, 1293, 1244 | 10 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 27, n=1233, 1262, 1206 | 15 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 30, n=1222, 1221, 1166 | 7 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 33, n=1202, 1199, 1128 | 4 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 36, n=1187, 1174, 1095 | 5 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 39, n=1160, 1144, 1055 | 6 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 42, n=1149, 1126, 1035 | 4 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 45, n=1129, 1110, 1009 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 48, n=1113, 1093, 990 | 1 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 18, n=1318, 1350, 1328 | 25 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 21, n=1281, 1326, 1287 | 21 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 24, n=1263, 1293, 1244 | 19 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 42, n=1149, 1126, 1035 | 8 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 27, n=1233, 1262, 1206 | 11 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 30, n=1222, 1221, 1166 | 8 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 48, n=1113, 1093, 990 | 6 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 33, n=1202, 1199, 1128 | 5 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 3, n=1550, 1581, 1564 | 25 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 45, n=1129, 1110, 1009 | 5 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 6, n=1479, 1517, 1514 | 34 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 36, n=1187, 1174, 1095 | 4 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 9, n=1439, 1465, 1477 | 35 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 12, n=1400, 1431, 1434 | 29 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 15, n=1343, 1386, 1380 | 22 visits |
| Dutasteride 0.5 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 39, n=1160, 1144, 1055 | 13 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 33, n=1202, 1199, 1128 | 10 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 18, n=1318, 1350, 1328 | 26 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 39, n=1160, 1144, 1055 | 19 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 9, n=1439, 1465, 1477 | 22 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 21, n=1281, 1326, 1287 | 14 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 48, n=1113, 1093, 990 | 5 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 3, n=1550, 1581, 1564 | 26 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 24, n=1263, 1293, 1244 | 21 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 36, n=1187, 1174, 1095 | 7 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 15, n=1343, 1386, 1380 | 27 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 27, n=1233, 1262, 1206 | 14 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 42, n=1149, 1126, 1035 | 12 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 6, n=1479, 1517, 1514 | 22 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 30, n=1222, 1221, 1166 | 10 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 12, n=1400, 1431, 1434 | 34 visits |
| Tamsulosin 0.4 mg | Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 45, n=1129, 1110, 1009 | 6 visits |
Secondary
Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?. If the answer to the question was yes, the number of visits was recorded.
Time frame: Every 3 months from Month 3 to Month 48
Population: ITT Population. As study progressed, participants dropped out the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 15, n=1343, 1386, 1381 | 19 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 6, n=1479, 1516, 1514 | 23 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 9, n=1439, 1465, 1477 | 12 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 12, n=1400, 1431, 1434 | 30 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 3, n=1550, 1581, 1564 | 27 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 18, n=1318, 1350, 1328 | 23 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 21, n=1281, 1326, 1287 | 20 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 24, n=1263, 1293, 1244 | 29 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 27, n=1233, 1262, 1206 | 13 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 30, n=1222, 1221, 1166 | 10 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 45, n=1129, 1110, 1009 | 5 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 33, n=1202, 1199, 1128 | 6 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 36, n=1187, 1174, 1095 | 8 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 39, n=1160, 1144, 1055 | 12 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 42, n=1149, 1126, 1035 | 15 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 48, n=1113, 1093, 990 | 7 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 18, n=1318, 1350, 1328 | 21 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 39, n=1160, 1144, 1055 | 10 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 21, n=1281, 1326, 1287 | 27 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 24, n=1263, 1293, 1244 | 23 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 48, n=1113, 1093, 990 | 4 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 27, n=1233, 1262, 1206 | 12 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 42, n=1149, 1126, 1035 | 9 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 30, n=1222, 1221, 1166 | 16 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 45, n=1129, 1110, 1009 | 7 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 33, n=1202, 1199, 1128 | 13 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 3, n=1550, 1581, 1564 | 27 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 6, n=1479, 1516, 1514 | 29 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 9, n=1439, 1465, 1477 | 27 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 36, n=1187, 1174, 1095 | 12 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 12, n=1400, 1431, 1434 | 28 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 15, n=1343, 1386, 1381 | 28 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 48, n=1113, 1093, 990 | 8 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 18, n=1318, 1350, 1328 | 34 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 15, n=1343, 1386, 1381 | 32 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 3, n=1550, 1581, 1564 | 30 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 21, n=1281, 1326, 1287 | 26 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 39, n=1160, 1144, 1055 | 18 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 33, n=1202, 1199, 1128 | 20 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 24, n=1263, 1293, 1244 | 26 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 12, n=1400, 1431, 1434 | 29 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 6, n=1479, 1516, 1514 | 33 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 27, n=1233, 1262, 1206 | 16 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 45, n=1129, 1110, 1009 | 8 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 36, n=1187, 1174, 1095 | 18 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 30, n=1222, 1221, 1166 | 10 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 42, n=1149, 1126, 1035 | 15 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.) | Month 9, n=1439, 1465, 1477 | 26 visits |
Secondary
Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit? If the answer to the question was yes, the number of visits was recorded.
Time frame: Every 3 months from Month 3 to Month 48
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 15, n=1343, 1386, 1380 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 6, n=1479, 1517, 1514 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 9, n=1439, 1465, 1477 | 4 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 12, n=1400, 1431, 1434 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 3, n=1550, 1581, 1565 | 8 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 18, n=1318, 1350, 1328 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 21, n=1281, 1326, 1287 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 24, n=1263, 1293, 1244 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 27, n=1233, 1262, 1206 | 1 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 30, n=1222, 1221, 1166 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 33, n=1202, 1199, 1128 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 36, n=1187, 1174, 1095 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 39, n=1160, 1144, 1055 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 42, n=1149, 1126, 1035 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 45, n=1129, 1110, 1009 | 1 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 48, n=1113, 1093, 990 | 1 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 18, n=1318, 1350, 1328 | 4 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 21, n=1281, 1326, 1287 | 3 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 24, n=1263, 1293, 1244 | 2 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 42, n=1149, 1126, 1035 | 2 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 27, n=1233, 1262, 1206 | 6 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 30, n=1222, 1221, 1166 | 2 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 48, n=1113, 1093, 990 | 2 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 33, n=1202, 1199, 1128 | 4 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 3, n=1550, 1581, 1565 | 6 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 45, n=1129, 1110, 1009 | 2 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 6, n=1479, 1517, 1514 | 4 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 36, n=1187, 1174, 1095 | 1 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 9, n=1439, 1465, 1477 | 3 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 12, n=1400, 1431, 1434 | 3 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 15, n=1343, 1386, 1380 | 6 visits |
| Dutasteride 0.5 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 39, n=1160, 1144, 1055 | 2 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 33, n=1202, 1199, 1128 | 5 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 18, n=1318, 1350, 1328 | 10 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 39, n=1160, 1144, 1055 | 5 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 9, n=1439, 1465, 1477 | 8 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 21, n=1281, 1326, 1287 | 9 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 48, n=1113, 1093, 990 | 2 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 3, n=1550, 1581, 1565 | 7 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 24, n=1263, 1293, 1244 | 7 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 36, n=1187, 1174, 1095 | 5 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 15, n=1343, 1386, 1380 | 6 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 27, n=1233, 1262, 1206 | 7 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 42, n=1149, 1126, 1035 | 8 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 6, n=1479, 1517, 1514 | 3 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 30, n=1222, 1221, 1166 | 8 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 12, n=1400, 1431, 1434 | 9 visits |
| Tamsulosin 0.4 mg | Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit | Month 45, n=1129, 1110, 1009 | 4 visits |
Secondary
Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was yes, the number of visits was recorded.
Time frame: Every 3 months from Month 3 to Month 48
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 33, n=1202, 1199, 1128 | 0 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 12, n=1400, 1431, 1434 | 1 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 36, n=1187, 1174, 1095 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 39, n=1160, 1144, 1055 | 1 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 6, n=1479, 1517, 1514 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 42, n=1149, 1126, 1035 | 1 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 15, n=1343, 1386, 1380 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 45, n=1129, 1110, 1009 | 0 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 48, n=1113, 1093, 990 | 0 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 18, n=1318, 1350, 1328 | 4 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 21, n=1281, 1326, 1287 | 1 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 9, n=1439, 1465, 1477 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 24, n=1263, 1293, 1244 | 2 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 27, n=1233, 1262, 1206 | 3 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 3, n=1550, 1581, 1564 | 0 visits |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 30, n=1222, 1221, 1165 | 0 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 30, n=1222, 1221, 1165 | 1 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 18, n=1318, 1350, 1328 | 0 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 3, n=1550, 1581, 1564 | 3 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 36, n=1187, 1174, 1095 | 2 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 12, n=1400, 1431, 1434 | 2 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 27, n=1233, 1262, 1206 | 3 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 39, n=1160, 1144, 1055 | 3 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 21, n=1281, 1326, 1287 | 0 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 48, n=1113, 1093, 990 | 2 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 42, n=1149, 1126, 1035 | 2 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 33, n=1202, 1199, 1128 | 1 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 24, n=1263, 1293, 1244 | 0 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 45, n=1129, 1110, 1009 | 3 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 15, n=1343, 1386, 1380 | 5 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 9, n=1439, 1465, 1477 | 2 visits |
| Dutasteride 0.5 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 6, n=1479, 1517, 1514 | 1 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 30, n=1222, 1221, 1165 | 1 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 3, n=1550, 1581, 1564 | 3 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 6, n=1479, 1517, 1514 | 2 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 9, n=1439, 1465, 1477 | 3 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 12, n=1400, 1431, 1434 | 7 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 15, n=1343, 1386, 1380 | 7 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 18, n=1318, 1350, 1328 | 4 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 21, n=1281, 1326, 1287 | 3 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 24, n=1263, 1293, 1244 | 3 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 27, n=1233, 1262, 1206 | 4 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 33, n=1202, 1199, 1128 | 5 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 36, n=1187, 1174, 1095 | 1 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 39, n=1160, 1144, 1055 | 2 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 42, n=1149, 1126, 1035 | 5 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 45, n=1129, 1110, 1009 | 2 visits |
| Tamsulosin 0.4 mg | Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit | Month 48, n=1113, 1093, 990 | 1 visits |
Secondary
Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?.
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?. If the answer to the question was yes, the number of Yes responses was recorded.
Time frame: Every 3 months from Month 3 to Month 48
Population: ITT Population. As the study progressed, participants dropped out of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 15, n=1343, 1386, 1380 | 9 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 6, n=1479, 1516, 1513 | 21 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 9, n=1439, 1465, 1477 | 18 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 12, n=1400, 1431, 1434 | 8 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 3, n=1550, 1581, 1564 | 31 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 18, n=1318, 1350, 1328 | 17 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 21, n=1281, 1326, 1287 | 10 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 24, n=1263, 1293, 1244 | 5 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 27, n=1233, 1262, 1206 | 9 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 30, n=1222, 1221, 1166 | 7 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 33, n=1202, 1199, 1128 | 9 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 36, n=1187, 1174, 1095 | 5 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 39, n=1160, 1144, 1055 | 7 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 42, n=1149, 1126, 1035 | 6 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 45, n=1129, 1110, 1009 | 7 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 48, n=1113, 1093, 990 | 2 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 18, n=1318, 1350, 1328 | 13 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 21, n=1281, 1326, 1287 | 15 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 24, n=1263, 1293, 1244 | 9 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 42, n=1149, 1126, 1035 | 8 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 27, n=1233, 1262, 1206 | 11 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 30, n=1222, 1221, 1166 | 9 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 48, n=1113, 1093, 990 | 9 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 33, n=1202, 1199, 1128 | 10 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 3, n=1550, 1581, 1564 | 32 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 45, n=1129, 1110, 1009 | 8 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 6, n=1479, 1516, 1513 | 26 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 36, n=1187, 1174, 1095 | 4 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 9, n=1439, 1465, 1477 | 14 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 12, n=1400, 1431, 1434 | 13 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 15, n=1343, 1386, 1380 | 15 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 39, n=1160, 1144, 1055 | 9 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 33, n=1202, 1199, 1128 | 11 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 18, n=1318, 1350, 1328 | 19 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 39, n=1160, 1144, 1055 | 6 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 9, n=1439, 1465, 1477 | 18 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 21, n=1281, 1326, 1287 | 17 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 48, n=1113, 1093, 990 | 5 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 3, n=1550, 1581, 1564 | 29 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 24, n=1263, 1293, 1244 | 8 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 36, n=1187, 1174, 1095 | 5 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 15, n=1343, 1386, 1380 | 12 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 27, n=1233, 1262, 1206 | 8 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 42, n=1149, 1126, 1035 | 8 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 6, n=1479, 1516, 1513 | 26 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 30, n=1222, 1221, 1166 | 9 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 12, n=1400, 1431, 1434 | 9 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?. | Month 45, n=1129, 1110, 1009 | 5 yes responses |
Secondary
Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?
At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was yes, the number of Yes responses was recorded.
Time frame: Every 3 months from Month 3 to Month 48
Population: ITT Population. As study progressed, participants dropped out of study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 15, n=1343, 1386, 1380 | 9 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 6, n=1479, 1516, 1513 | 20 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 9, n=1438, 1465, 1477 | 12 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 12, n=1400, 1431, 1434 | 5 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 3, n=1550, 1581, 1564 | 16 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 18, n=1318, 1350, 1328 | 13 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 21, n=1281, 1326, 1287 | 10 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 24, n=1263, 1293, 1244 | 4 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 27, n=1233, 1262, 1206 | 9 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 30, n=1222, 1221, 1166 | 7 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 33, n=1202, 1199, 1128 | 5 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 36, n=1187, 1174, 1095 | 3 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 39, n=1160, 1144, 1055 | 7 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 42, n=1149, 1126, 1034 | 9 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 45, n=1129, 1110, 1009 | 6 yes responses |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 48, n=1113, 1093, 990 | 1 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 18, n=1318, 1350, 1328 | 12 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 21, n=1281, 1326, 1287 | 9 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 24, n=1263, 1293, 1244 | 7 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 42, n=1149, 1126, 1034 | 8 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 27, n=1233, 1262, 1206 | 9 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 30, n=1222, 1221, 1166 | 9 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 48, n=1113, 1093, 990 | 3 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 33, n=1202, 1199, 1128 | 7 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 3, n=1550, 1581, 1564 | 34 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 45, n=1129, 1110, 1009 | 8 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 6, n=1479, 1516, 1513 | 23 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 36, n=1187, 1174, 1095 | 5 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 9, n=1438, 1465, 1477 | 10 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 12, n=1400, 1431, 1434 | 10 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 15, n=1343, 1386, 1380 | 9 yes responses |
| Dutasteride 0.5 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 39, n=1160, 1144, 1055 | 8 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 33, n=1202, 1199, 1128 | 8 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 18, n=1318, 1350, 1328 | 10 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 39, n=1160, 1144, 1055 | 5 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 9, n=1438, 1465, 1477 | 17 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 21, n=1281, 1326, 1287 | 8 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 48, n=1113, 1093, 990 | 1 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 3, n=1550, 1581, 1564 | 28 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 24, n=1263, 1293, 1244 | 3 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 36, n=1187, 1174, 1095 | 2 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 15, n=1343, 1386, 1380 | 9 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 27, n=1233, 1262, 1206 | 5 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 42, n=1149, 1126, 1034 | 2 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 6, n=1479, 1516, 1513 | 16 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 30, n=1222, 1221, 1166 | 4 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 12, n=1400, 1431, 1434 | 6 yes responses |
| Tamsulosin 0.4 mg | Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit? | Month 45, n=1129, 1110, 1009 | 5 yes responses |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?. Satisfact., satisfaction.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | Baseline (BL), Any Satisfact., n=1574, 1600, 1576 | 611 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | BL, Neutral /Any Dissatisfact., n=1574, 1600, 1576 | 963 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | Month (M) 12, Any Satisfact., n=1575, 1593, 1580 | 1176 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M12, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 399 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M24, Any Satisfact., n=1575, 1593, 1580 | 1205 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M24, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 370 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M36, Any Satisfact., n=1575, 1593, 1580 | 1210 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M36, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 365 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M48, Any Satisfact., n=1575, 1593, 1580 | 1213 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M48, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 362 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M48, Any Satisfact., n=1575, 1593, 1580 | 1123 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | Baseline (BL), Any Satisfact., n=1574, 1600, 1576 | 565 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M24, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 477 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M24, Any Satisfact., n=1575, 1593, 1580 | 1116 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | BL, Neutral /Any Dissatisfact., n=1574, 1600, 1576 | 1035 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M48, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 470 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M36, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 495 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | Month (M) 12, Any Satisfact., n=1575, 1593, 1580 | 1073 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M36, Any Satisfact., n=1575, 1593, 1580 | 1098 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M12, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 520 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M36, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 506 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M12, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 466 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M24, Any Satisfact., n=1575, 1593, 1580 | 1088 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M24, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 492 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M48, Any Satisfact., n=1575, 1593, 1580 | 1043 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M36, Any Satisfact., n=1575, 1593, 1580 | 1074 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | Baseline (BL), Any Satisfact., n=1574, 1600, 1576 | 584 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | M48, Neutral/Any Dissatisfact., n=1575, 1593, 1580 | 537 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | BL, Neutral /Any Dissatisfact., n=1574, 1600, 1576 | 992 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF) | Month (M) 12, Any Satisfact., n=1575, 1593, 1580 | 1114 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Overall, how satisfied are you with the study medication and it's effect on your urinary problems?. Satisfact., satisfaction.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | Month (M) 12, Any Satisfact., n=1574, 1592, 1581 | 150 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M36, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 304 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M48, Any Satifact., n=1574, 1592, 1581 | 1262 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | Baseline (BL), Any Satisfact., n=1573, 1598, 1574 | 717 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M48, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 312 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M12, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 324 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | BL, Neutral/Any Dissatisfact., n=1573, 1598, 1574 | 856 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M24, Any Satisfact., n=1574, 1592, 1581 | 1279 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M24, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 295 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M36, Any Satisfact., n=1574, 1592, 1581 | 1270 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | BL, Neutral/Any Dissatisfact., n=1573, 1598, 1574 | 915 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M12, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 433 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M36, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 404 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | Month (M) 12, Any Satisfact., n=1574, 1592, 1581 | 1159 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M36, Any Satisfact., n=1574, 1592, 1581 | 1188 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M48, Any Satifact., n=1574, 1592, 1581 | 1182 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | Baseline (BL), Any Satisfact., n=1573, 1598, 1574 | 683 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M24, Any Satisfact., n=1574, 1592, 1581 | 1188 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M48, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 410 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M24, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 404 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M48, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 484 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | Baseline (BL), Any Satisfact., n=1573, 1598, 1574 | 699 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | BL, Neutral/Any Dissatisfact., n=1573, 1598, 1574 | 875 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | Month (M) 12, Any Satisfact., n=1574, 1592, 1581 | 1202 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M12, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 379 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M24, Any Satisfact., n=1574, 1592, 1581 | 1163 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M24, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 418 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M36, Any Satisfact., n=1574, 1592, 1581 | 1119 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M36, Neutral/Any Dissatisfact., n=1574, 1592, 1581 | 462 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF) | M48, Any Satifact., n=1574, 1592, 1581 | 1097 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Would you ask your doctor for the medication you received in this study?.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 36, Yes, n=1574, 1592, 1581 | 1031 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 36, No/Not Sure, n=1574, 1592, 1581 | 543 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 12, Yes, n=1574, 1592, 1581 | 972 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 48, Yes, n=1574, 1592, 1581 | 1003 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 48, No/Not Sure, n=1574, 1592, 1581 | 571 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Baseline, Yes, n=1560, 1579, 1562 | 587 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 12, No/Not Sure, n=1574, 1592, 1581 | 602 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Baseline, No/Not Sure, n=1560, 1579, 1562 | 973 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 24, Yes, n=1574, 1592, 1581 | 1027 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 24, No/Not Sure, n=1574, 1592, 1581 | 547 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 36, Yes, n=1574, 1592, 1581 | 956 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 12, No/Not Sure, n=1574, 1592, 1581 | 671 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 36, No/Not Sure, n=1574, 1592, 1581 | 636 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 24, No/Not Sure, n=1574, 1592, 1581 | 636 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Baseline, Yes, n=1560, 1579, 1562 | 557 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 48, Yes, n=1574, 1592, 1581 | 918 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 12, Yes, n=1574, 1592, 1581 | 920 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 24, Yes, n=1574, 1592, 1581 | 955 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 48, No/Not Sure, n=1574, 1592, 1581 | 674 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Baseline, No/Not Sure, n=1560, 1579, 1562 | 1022 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 48, No/Not Sure, n=1574, 1592, 1581 | 707 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Baseline, Yes, n=1560, 1579, 1562 | 582 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Baseline, No/Not Sure, n=1560, 1579, 1562 | 980 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 12, Yes, n=1574, 1592, 1581 | 970 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 12, No/Not Sure, n=1574, 1592, 1581 | 611 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 24, Yes, n=1574, 1592, 1581 | 952 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 24, No/Not Sure, n=1574, 1592, 1581 | 629 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 36, No/Not Sure, n=1574, 1592, 1581 | 666 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 48, Yes, n=1574, 1592, 1581 | 874 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF) | Month 36, Yes, n=1574, 1592, 1581 | 915 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has control of your urinary problems changed?.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M48, Any Improvement, n=1576, 1593, 1581 | 1278 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M36, No Change/Any Worsening, n=1576, 1593, 1581 | 308 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M24, Any Improvement, n=1576, 1593, 1581 | 1273 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M12, No Change/Any Worsening, n=1576, 1593, 1581 | 295 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M48, No Change/Any Worsening, n=1576, 1593, 1581 | 298 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | BL, No Change/Any Worsening, n=1585, 1600, 1586 | 889 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M24, No Change/Any Worsening, n=1576, 1593, 1581 | 303 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | Baseline (BL), Any Improvement, n=1585, 1600, 1586 | 696 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | Month (M) 12, Any Improvement, n=1576, 1593, 1581 | 1281 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M36, Any Improvement, n=1576, 1593, 1581 | 1268 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M12, No Change/Any Worsening, n=1576, 1593, 1581 | 422 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | Month (M) 12, Any Improvement, n=1576, 1593, 1581 | 1171 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M48, Any Improvement, n=1576, 1593, 1581 | 1212 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M48, No Change/Any Worsening, n=1576, 1593, 1581 | 381 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M36, Any Improvement, n=1576, 1593, 1581 | 1203 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | BL, No Change/Any Worsening, n=1585, 1600, 1586 | 944 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M36, No Change/Any Worsening, n=1576, 1593, 1581 | 390 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M24, Any Improvement, n=1576, 1593, 1581 | 1200 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | Baseline (BL), Any Improvement, n=1585, 1600, 1586 | 656 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M24, No Change/Any Worsening, n=1576, 1593, 1581 | 393 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M48, No Change/Any Worsening, n=1576, 1593, 1581 | 443 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | Baseline (BL), Any Improvement, n=1585, 1600, 1586 | 706 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | BL, No Change/Any Worsening, n=1585, 1600, 1586 | 880 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | Month (M) 12, Any Improvement, n=1576, 1593, 1581 | 1218 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M12, No Change/Any Worsening, n=1576, 1593, 1581 | 363 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M24, Any Improvement, n=1576, 1593, 1581 | 1195 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M24, No Change/Any Worsening, n=1576, 1593, 1581 | 386 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M36, Any Improvement, n=1576, 1593, 1581 | 1152 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M36, No Change/Any Worsening, n=1576, 1593, 1581 | 429 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF) | M48, Any Improvement, n=1576, 1593, 1581 | 1138 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on control of your urinary problems? Satisfact., satisfaction.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M36, Any Satisfact., n=1576, 1593, 1581 | 1260 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | Month (M) 12, Any Satisfact., n=1576, 1593, 1581 | 1224 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 316 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M48, Any Satisfact., n=1576, 1593, 1581 | 1267 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 309 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | Baseline (BL), Any Satisfact., n=1587, 1600, 1583 | 707 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 352 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | BL, Neutral/Any Dissatisfact., n=1587, 1600, 1583 | 880 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M24, Any Satisfact., n=1576, 1593, 1581 | 1261 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 315 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M36, Any Satisfact., n=1576, 1593, 1581 | 1167 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 466 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 427 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 426 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | Baseline (BL), Any Satisfact., n=1587, 1600, 1583 | 652 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M48, Any Satisfact., n=1576, 1593, 1581 | 1172 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | Month (M) 12, Any Satisfact., n=1576, 1593, 1581 | 1127 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M24, Any Satisfact., n=1576, 1593, 1581 | 1166 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 421 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | BL, Neutral/Any Dissatisfact., n=1587, 1600, 1583 | 948 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 493 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | Baseline (BL), Any Satisfact., n=1587, 1600, 1583 | 686 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | BL, Neutral/Any Dissatisfact., n=1587, 1600, 1583 | 897 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | Month (M) 12, Any Satisfact., n=1576, 1593, 1581 | 1178 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 403 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M24, Any Satisfact., n=1576, 1593, 1581 | 1150 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 431 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M36, Any Satisfact., n=1576, 1593, 1581 | 1120 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M48, Any Satisfact., n=1576, 1593, 1581 | 1088 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF) | M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 461 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the strength of your urinary stream changed?.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M12, No Change/Any Worsening, n=1576, 1593, 1581 | 395 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | BL, No Change/Any Worsening, n=1585, 1601, 1585 | 956 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | Baseline (BL), Any Improvement, n=1585, 1601, 1585 | 629 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M24, Any Improvement, n=1576, 1593, 1581 | 1215 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M48, No Change/Any Worsening, n=1576, 1593, 1581 | 374 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | Month (M) 12, Any Improvement, n=1576, 1593, 158 | 1181 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M24, No Change/Any Worsening, n=1576, 1593, 1581 | 361 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M48, Any Improvement, n=1576, 1593, 1581 | 1202 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M36, Any Improvement, n=1576, 1593, 1581 | 1206 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M36, No Change/Any Worsening, n=1576, 1593, 1581 | 370 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M36, Any Improvement, n=1576, 1593, 1581 | 1071 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M36, No Change/Any Worsening, n=1576, 1593, 1581 | 522 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M48, Any Improvement, n=1576, 1593, 1581 | 1086 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | BL, No Change/Any Worsening, n=1585, 1601, 1585 | 999 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M48, No Change/Any Worsening, n=1576, 1593, 1581 | 507 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | Baseline (BL), Any Improvement, n=1585, 1601, 1585 | 602 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M12, No Change/Any Worsening, n=1576, 1593, 1581 | 549 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M24, Any Improvement, n=1576, 1593, 1581 | 1070 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M24, No Change/Any Worsening, n=1576, 1593, 1581 | 523 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | Month (M) 12, Any Improvement, n=1576, 1593, 158 | 1044 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M48, No Change/Any Worsening, n=1576, 1593, 1581 | 573 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | Baseline (BL), Any Improvement, n=1585, 1601, 1585 | 615 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | BL, No Change/Any Worsening, n=1585, 1601, 1585 | 970 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | Month (M) 12, Any Improvement, n=1576, 1593, 158 | 1105 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M24, No Change/Any Worsening, n=1576, 1593, 1581 | 524 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M12, No Change/Any Worsening, n=1576, 1593, 1581 | 476 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M24, Any Improvement, n=1576, 1593, 1581 | 1057 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M36, Any Improvement, n=1576, 1593, 1581 | 1023 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M36, No Change/Any Worsening, n=1576, 1593, 1581 | 558 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF) | M48, Any Improvement, n=1576, 1593, 1581 | 1008 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on the strength of your urinary stream?. Satisfact., satisfaction.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | Baseline (BL), Any Satisfact., n=1583,1601,1582 | 632 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | BL, Neutral/Any Dissatisfact., n=1583,1601,1582 | 951 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | Month (M) 12, Any Satisfact., n=1576, 1593, 1581 | 1154 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 422 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M24, Any Satisfact., n=1576, 1593, 1581 | 1203 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 373 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M36, Any Satisfact., n=1576, 1593, 1581 | 1201 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 375 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M48, Any Satisfact., n=1576, 1593, 1581 | 1208 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 368 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M48, Any Satisfact., n=1576, 1593, 1581 | 1089 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | Baseline (BL), Any Satisfact., n=1583,1601,1582 | 586 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 521 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M24, Any Satisfact., n=1576, 1593, 1581 | 1072 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | BL, Neutral/Any Dissatisfact., n=1583,1601,1582 | 1015 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 504 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 518 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | Month (M) 12, Any Satisfact., n=1576, 1593, 1581 | 1037 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M36, Any Satisfact., n=1576, 1593, 1581 | 1075 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 556 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M36, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 542 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M12, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 484 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M24, Any Satisfact., n=1576, 1593, 1581 | 1051 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M24, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 530 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M48, Any Satisfact., n=1576, 1593, 1581 | 1022 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M36, Any Satisfact., n=1576, 1593, 1581 | 1039 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | Baseline (BL), Any Satisfact., n=1583,1601,1582 | 613 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | M48, Neutral/Any Dissatisfact., n=1576, 1593, 1581 | 559 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | BL, Neutral/Any Dissatisfact., n=1583,1601,1582 | 969 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF) | Month (M) 12, Any Satisfact., n=1576, 1593, 1581 | 1097 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain prior to urinating changed?.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | Baseline (BL), Any Improvement, n=869, 901, 849 | 337 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | BL, No Change/Any Worsening, n=869, 901, 849 | 532 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | Month (M) 12, Any Improvement, n=769, 817, 771 | 556 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M12, No Change/Any Worsening, n=769, 817, 771 | 213 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M24, Any Improvement, n=720, 780, 771 | 537 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M24, No Change/Any Worsening, n=720, 780, 771 | 183 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M36, Any Improvement, n=714, 753, 748 | 540 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M36, No Change/Any Worsening, n=714, 753, 748 | 174 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M48, Any Improvement, n=709, 756, 751 | 531 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M48, No Change/Any Worsening, n=709, 756, 751 | 178 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M48, Any Improvement, n=709, 756, 751 | 510 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | Baseline (BL), Any Improvement, n=869, 901, 849 | 331 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M24, No Change/Any Worsening, n=720, 780, 771 | 254 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M24, Any Improvement, n=720, 780, 771 | 526 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | BL, No Change/Any Worsening, n=869, 901, 849 | 570 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M48, No Change/Any Worsening, n=709, 756, 751 | 246 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M36, No Change/Any Worsening, n=714, 753, 748 | 239 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | Month (M) 12, Any Improvement, n=769, 817, 771 | 526 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M36, Any Improvement, n=714, 753, 748 | 514 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M12, No Change/Any Worsening, n=769, 817, 771 | 291 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M36, No Change/Any Worsening, n=714, 753, 748 | 252 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M12, No Change/Any Worsening, n=769, 817, 771 | 244 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M24, Any Improvement, n=720, 780, 771 | 535 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M24, No Change/Any Worsening, n=720, 780, 771 | 236 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M48, Any Improvement, n=709, 756, 751 | 489 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M36, Any Improvement, n=714, 753, 748 | 496 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | Baseline (BL), Any Improvement, n=869, 901, 849 | 332 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | M48, No Change/Any Worsening, n=709, 756, 751 | 262 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | BL, No Change/Any Worsening, n=869, 901, 849 | 517 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF) | Month (M) 12, Any Improvement, n=769, 817, 771 | 527 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain prior to urinating?. Satisfact., satisfaction.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M36, Any Satisfact., n=1115, 1200, 1135 | 799 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M36, Neutral/Any Dissatisfact., n=1115, 1200, 1135 | 316 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M48, Neutral/Any Dissatisfact., n=1135, 1223, 1161 | 325 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M48, Any Satisfact., n=1135, 1223, 1161 | 810 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | BL, Neutral/Any Dissatisfact., n=908, 932, 889 | 533 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | Baseline (BL), Any Satisfact., n=908, 932, 889 | 375 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M12, Neutral/Any Dissatisfact., n=1022, 1088, 1019 | 310 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M24, Any Satisfact., n=1077, 1151, 1085 | 764 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M24, Neutral/Any Dissatisfact., n=1077, 1151, 1085 | 313 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | Month (M) 12, Any Satisfact., n=1022, 1088, 1019 | 712 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M36, Any Satisfact., n=1115, 1200, 1135 | 785 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | Month (M) 12, Any Satisfact., n=1022, 1088, 1019 | 672 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M12, Neutral/Any Dissatisfact., n=1022, 1088, 1019 | 416 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M36, Neutral/Any Dissatisfact., n=1115, 1200, 1135 | 415 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | BL, Neutral/Any Dissatisfact., n=908, 932, 889 | 581 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M24, Neutral/Any Dissatisfact., n=1077, 1151, 1085 | 411 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M48, Any Satisfact., n=1135, 1223, 1161 | 792 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M24, Any Satisfact., n=1077, 1151, 1085 | 740 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M48, Neutral/Any Dissatisfact., n=1135, 1223, 1161 | 431 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | Baseline (BL), Any Satisfact., n=908, 932, 889 | 351 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M48, Neutral/Any Dissatisfact., n=1135, 1223, 1161 | 422 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | Baseline (BL), Any Satisfact., n=908, 932, 889 | 351 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | BL, Neutral/Any Dissatisfact., n=908, 932, 889 | 538 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | Month (M) 12, Any Satisfact., n=1022, 1088, 1019 | 681 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M12, Neutral/Any Dissatisfact., n=1022, 1088, 1019 | 338 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M24, Any Satisfact., n=1077, 1151, 1085 | 708 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M24, Neutral/Any Dissatisfact., n=1077, 1151, 1085 | 377 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M36, Any Satisfact., n=1115, 1200, 1135 | 736 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M36, Neutral/Any Dissatisfact., n=1115, 1200, 1135 | 399 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF) | M48, Any Satisfact., n=1135, 1223, 1161 | 739 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain during urination changed?.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M12, No Change/Any Worsening, n=760, 781, 755 | 210 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M36, No Change/Any Worsening, n=704, 741, 733 | 175 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | BL, No Change/Any Worsening, n=852, 889, 822 | 531 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M24, Any Improvement, n=706, 760, 747 | 532 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | Month (M) 12, Any Improvement, n=760, 781, 755 | 550 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M24, No Change/Any Worsening, n=706, 760, 747 | 174 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M48, Any Improvement, n=702, 739, 740 | 527 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M48, No Change/Any Worsening, n=702, 739, 740 | 175 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M36, Any Improvement, n=704, 741, 733 | 529 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | Baseline (BL), Any Improvement, n=852, 889, 822 | 321 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M36, Any Improvement, n=704, 741, 733 | 504 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M36, No Change/Any Worsening, n=704, 741, 733 | 237 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M48, No Change/Any Worsening, n=702, 739, 740 | 252 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | Month (M) 12, Any Improvement, n=760, 781, 755 | 500 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M48, Any Improvement, n=702, 739, 740 | 487 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M12, No Change/Any Worsening, n=760, 781, 755 | 281 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M24, Any Improvement, n=706, 760, 747 | 508 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M24, No Change/Any Worsening, n=706, 760, 747 | 252 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | BL, No Change/Any Worsening, n=852, 889, 822 | 575 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | Baseline (BL), Any Improvement, n=852, 889, 822 | 314 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M48, Any Improvement, n=702, 739, 740 | 483 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | Baseline (BL), Any Improvement, n=852, 889, 822 | 319 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | BL, No Change/Any Worsening, n=852, 889, 822 | 503 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | Month (M) 12, Any Improvement, n=760, 781, 755 | 529 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M12, No Change/Any Worsening, n=760, 781, 755 | 226 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M24, No Change/Any Worsening, n=706, 760, 747 | 228 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M36, Any Improvement, n=704, 741, 733 | 491 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M36, No Change/Any Worsening, n=704, 741, 733 | 242 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M48, No Change/Any Worsening, n=702, 739, 740 | 257 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF) | M24, Any Improvement, n=706, 760, 747 | 519 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain during urination?. Satisfact., satisfaction.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M48, Neutral/Any Dissatisfact., n=1146, 1224, 1160 | 319 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M36, Any Satisfact., n=1121, 1206, 1131 | 807 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M24, Any Satisfact., n=1077, 1155, 1079 | 763 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | BL, Neutral/Any Dissatisfact., n=890, 925, 851 | 536 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M24, Neutral/Any Dissatisfact., n=1077, 1155, 1079 | 314 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | Baseline (BL), Any Satisfact., n=890, 925, 851 | 354 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M48, Any Satsifact., n=1146,1224,1160 | 827 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | Month (M) 12, Any Satisfact., n=1022, 1088, 1011 | 712 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M36, Neutral/Any Dissatisfact., n=1121, 1206, 1131 | 314 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M12, Neutral/Any Dissatisfact., n=1022, 1088, 1011 | 310 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | Month (M) 12, Any Satisfact., n=1022, 1088, 1011 | 655 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | Baseline (BL), Any Satisfact., n=890, 925, 851 | 348 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | BL, Neutral/Any Dissatisfact., n=890, 925, 851 | 577 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M12, Neutral/Any Dissatisfact., n=1022, 1088, 1011 | 433 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M24, Any Satisfact., n=1077, 1155, 1079 | 730 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M24, Neutral/Any Dissatisfact., n=1077, 1155, 1079 | 425 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M36, Any Satisfact., n=1121, 1206, 1131 | 784 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M36, Neutral/Any Dissatisfact., n=1121, 1206, 1131 | 422 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M48, Any Satsifact., n=1146,1224,1160 | 785 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M48, Neutral/Any Dissatisfact., n=1146, 1224, 1160 | 439 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M36, Any Satisfact., n=1121, 1206, 1131 | 724 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | Month (M) 12, Any Satisfact., n=1022, 1088, 1011 | 678 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | Baseline (BL), Any Satisfact., n=890, 925, 851 | 333 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M36, Neutral/Any Dissatisfact., n=1121, 1206, 1131 | 407 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | BL, Neutral/Any Dissatisfact., n=890, 925, 851 | 518 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M24, Any Satisfact., n=1077, 1155, 1079 | 708 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M48, Neutral/Any Dissatisfact., n=1146, 1224, 1160 | 431 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M24, Neutral/Any Dissatisfact., n=1077, 1155, 1079 | 371 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M12, Neutral/Any Dissatisfact., n=1022, 1088, 1011 | 333 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF) | M48, Any Satsifact., n=1146,1224,1160 | 729 participants |
Secondary
Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)
This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?.
Time frame: Baseline and Months 12, 24, 36, and 48
Population: ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | Month (M) 12, Any Improvement, n=1575, 1593, 1580 | 1124 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M48, No Change/Any Worsening, n=1575, 1593, 1580 | 427 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M24, Any Improvement, n=1575, 1593, 1580 | 1146 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | BL, No Change/Any Worsening, n=1574, 1599, 1575 | 1065 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | Baseline (BL), Any Improvement, n=1574, 1599, 1575 | 509 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M36, No Change/Any Worsening, n=1575, 1593, 1580 | 412 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M36, Any Improvement, n=1575, 1593, 1580 | 1575 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M12, No Change/Any Worsening, n=1575, 1593, 1580 | 451 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M48, Any Improvement, n=1575, 1593, 1580 | 1148 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M24, No Change/Any Worsening, n=1575, 1593, 1580 | 429 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | Baseline (BL), Any Improvement, n=1574, 1599, 1575 | 481 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M36, Any Improvement, n=1575, 1593, 1580 | 1593 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M36, No Change/Any Worsening, n=1575, 1593, 1580 | 529 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M48, Any Improvement, n=1575, 1593, 1580 | 1063 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M48, No Change/Any Worsening, n=1575, 1593, 1580 | 530 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M24, No Change/Any Worsening, n=1575, 1593, 1580 | 540 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | BL, No Change/Any Worsening, n=1574, 1599, 1575 | 1118 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | Month (M) 12, Any Improvement, n=1575, 1593, 1580 | 1027 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M12, No Change/Any Worsening, n=1575, 1593, 1580 | 566 participants |
| Dutasteride 0.5 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M24, Any Improvement, n=1575, 1593, 1580 | 1053 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M48, Any Improvement, n=1575, 1593, 1580 | 1008 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M24, No Change/Any Worsening, n=1575, 1593, 1580 | 531 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | Month (M) 12, Any Improvement, n=1575, 1593, 1580 | 1084 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M36, No Change/Any Worsening, n=1575, 1593, 1580 | 553 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M24, Any Improvement, n=1575, 1593, 1580 | 1049 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M12, No Change/Any Worsening, n=1575, 1593, 1580 | 496 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | Baseline (BL), Any Improvement, n=1574, 1599, 1575 | 494 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M48, No Change/Any Worsening, n=1575, 1593, 1580 | 572 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | M36, Any Improvement, n=1575, 1593, 1580 | 1580 participants |
| Tamsulosin 0.4 mg | Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF) | BL, No Change/Any Worsening, n=1574, 1599, 1575 | 1081 participants |
Secondary
The Number of Participants With Each of the Five Components of BPH Clinical Progression
The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.
Time frame: Baseline (Day 1) to Year 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related renal insufficiency | 1 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | Recurrent BPH-related UTI | 2 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | Symptom deterioration | 132 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related incontinence | 46 participants |
| Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related AUR | 22 participants |
| Dutasteride 0.5 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related incontinence | 49 participants |
| Dutasteride 0.5 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | Recurrent BPH-related UTI | 5 participants |
| Dutasteride 0.5 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related renal insufficiency | 2 participants |
| Dutasteride 0.5 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | Symptom deterioration | 203 participants |
| Dutasteride 0.5 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related AUR | 31 participants |
| Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | Symptom deterioration | 221 participants |
| Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | Recurrent BPH-related UTI | 3 participants |
| Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related incontinence | 56 participants |
| Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related renal insufficiency | 5 participants |
| Tamsulosin 0.4 mg | The Number of Participants With Each of the Five Components of BPH Clinical Progression | BPH-related AUR | 64 participants |