Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

A Randomized, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride (0.5mg) and Tamsulosin (0.2mg) With Tamsulosin (0.2mg) Monotherapy, Administered Once Daily for 2 Years, on the Improvement of Symptoms and Health Outcomes in Men With Moderate to Severe Benign Prostatic Hyperplasia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02058368

Enrollment

607

Registered

2014-02-10

Start date

2014-02-10

Completion date

2017-03-03

Last updated

2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia, Quality of Life

Brief summary

This is a multicentre, randomised, double-blind, parallel group study in Asian subjects. The aim of the study is to investigate whether combination therapy with dutasteride and tamsulosin is more effective than tamsulosin monotherapy for the improvement of symptoms and health outcomes in an at risk population of benign prostatic hyperplasia (BPH) clinical progression including older men (\>=50 years), with moderate-severe symptoms of BPH, enlarged prostates (\>=30 cubicentimeter \[cc\]) and prostate specific antigen (PSA) \>= 1.5 nanograms per milliliter (ng/mL). Each subject who met the eligibility criteria at screening will enter a four-week single-blind, placebo run-in period following which each subject will be randomised into a 2 year double-blind treatment phase. The total study duration for each subject will be up to 110 weeks.

Interventions

DRUGDutasteride 0.5mg capsules

Dutasteride 0.5mg capsules will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules.

DRUGDutasteride placebo capsules

Dutasteride placebo will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules.

DRUGTamsulosin 0.2mg tablets

Commercially available tamsulosin 0.2mg tablets will be supplied.

DRUGDisintegrating placebo tamsulosin tablet

Disintegrating placebo tamsulosin tablet will be supplied for the run-in period.

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

Inclusion criteria

* 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 \>=30cc (by TRUS) * Total serum Prostate Specific Antigen (PSA) \>=1.5ng/mL and \<= 10 ng/mL at Screening * Maximum urinary flow rate (Qmax) \>5mL/sec and 15mL/sec and minimum voided volume of \>=125 milliliter (mL) at Screening * Asparate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin \<= 1.5xULN (isolated bilirubin \> 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%) * Fluent and literate in local language with the ability to comprehend and record information on the IPSS, BPH-related Health Status (BHS), BPH Impact Index (BII), and Problem Assessment Scale Sexual Function Inventory (PAS- SFI) questionnaires * Men with a female partner of childbearing potential must agree to use a condom up to 6 months after the last dose (applies only to countries where the local product monograph for dutasteride mandates condom use for men with a female partner of childbearing potential)

Exclusion criteria

* History or evidence of prostate cancer (e.g. positive biopsy or ultrasound, suspicious Digital Rectal Examination \[DRE\]). 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, including consideration of prostate biopsy. * Previous prostatic surgery (including TURP, laser, transrectal high intensity focused ultrasounds(HIFU), thermotherapy, transurethral needle ablation (TUNA), balloon dilatation, 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. Catheterisation (\<10F) 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 conditions other than BPH, which may in the judgment 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). * Unstable liver disease (chronic stable hepatitis B and C are acceptable if subject meets entry criteria). * History of renal insufficiency, or serum creatinine \>1.5 times the upper limit of normal at Screening. * Any unstable, serious co-existing medical condition(s) including, but not limited to: 1. 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. 2. 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. 3. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to study procedures in the opinion of the investigator or GSK medical monitor. Investigator may consult with GSK Medical Monitor if condition could interfere with subject's safety 4. History of breast cancer or clinical breast examination finding suggestive of malignancy. 5. History of malignancy within the past five years, except for basal cell carcinoma of the skin. Subjects with a priori malignancy who have had no evidence of disease for at least the past 5 years are eligible. * Current or Previous Use of the following medications: 1. Use of any 5-alpha-reductase inhibitor (e.g. finasteride), any drugs with antiandrogenic properties (e.g. spironolactone, flutamide, bicalutamide, cimetidine, ketoconazole, progestational agents), or other drugs noted for gynaecomastia effects, or that could affect prostate volume, within the 6 months preceding the historical TRUS or Screening Visit and throughout the study (other than as study medication). Previous use of dutasteride should not be within 6 months of the baseline or historical TRUS. 2. Anabolic steroids (subject must discontinue for 6 months prior to study entry to be eligible) and agree not to take them for the duration of the study. 3. Phytotherapy for BPH within 2 weeks of Screening Visit and/or predicted to need phytotherapy during the study. 4. Use of any alpha-adrenoreceptor blockers within 2 weeks of Screening Visit (i.e. indoramin, prazosin, terazosin, tamsulosin, alfuzosin, doxazosin, silodosin) and/or predicted to need any alpha blockers other than the study prescribed tamsulosin. 5. Use of any alpha-adrenoreceptor agonists (e.g. pseudoephedrine, phenylephedrine, ephedrine) or anticholinergics (e.g. oxybutynin,tolterodine, darifenacin, solifenacin,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. * Participation in any investigational or marketed drug trial within 30 days (or 5 half-lives of drug, whichever is the longer) preceding the Screening Visit and/or plans to participate in such a trial during the course of this study.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months	IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value.

Secondary

Measure	Time frame	Description
Percent Change in Prostate Volume From Baseline	Baseline,12 and 24 months	Prostate Volume measurements were conducted annually using Transrectal ultrasound (TRUS). The following calculation was utilized to assess the prostate volume (cc): pi/6 (Anteroposterior Width multiplied by Cephalocaudal Width multiplied by Transverse Width). Post-Baseline prostate volume was calculated at 12 and 24 months. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value and reported as a percentage.
Number of Participants With IPSS Improvement From Baseline	Baseline and 3, 6, 9,12,15,18,21 and 24 months	Improvement in IPSS was categorized as improvement, no change and worsening. Improvement defined as greater than or equal to 2 points, greater than or equal to 3 points and greater than or equal to 25 percent in participants at months 3,6,9,12,15,18,21 and 24 . Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value.
Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Baseline, 6, 12, 18 and 24 Months	Qmax is defined as maximum urine flow. Qmax was measured with Uroflow meter (Urodyn 1000) at Screening, Baseline, and at Months 6,12,18 and 24. Change from Baseline Qmax at each scheduled post-Baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline Qmax. Baseline value was defined as the latest non-missing assessment either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Baseline 6, 12, 18 and 24 Months	Qmax change from Baseline was presented using six improvement levels: \>0 milliliter per second (mL/sec) and \>=1 mL/sec through \>=5mL/sec. Qmax percentage change from Baseline was presented using six improvement levels: \>0%, \>=10%, \>=20%, \>=30%, \>=40%, and \>=50%. Here, Qmax improvement of \>= 3 mL/sec and Qmax percentage of \>= 30 % for 24 Months has been summarized. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date.
Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Up to 24 Months	AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization. AUR or BPH-related surgery event details per participant was summarized as first occurring of either AUR or BPH-related surgery.
Number of Subjects With AUR	Up to 24 Months	AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization.
Number of Participants With BPH-related Surgery	Up to 24 Months	BPH-related interventions were recorded. BPH-related interventions included adenomectomy, balloon dilatation, electroresection, thermotherapy (microwave or radiofrequency), laser resection, prostatectomy, prostatotomy, transurethral resection of the prostate, transurethral drainage of prostatic abscess, drainage of prostatic cysts, radioactive seeding of the prostate, prostatic urethral stenting, incision of periurethral stricture, ethanol injections into the prostate, transrectal high intensity focussed ultrasound, transurethral needle ablation and transurethral microwave thermotherapy.
Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 Months	BHS was collected as Question 8 the IPSS questionnaire regarding quality of life due to urinary symptom with scores values ranging from 0 (delightful) to 6 (terrible). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from baseline BHS at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BHS.
Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months	The BII consists of four questions and BII total score is the sum of four questions. Total score range is 0 (no problem) to 13 (worst value). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline BII at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BII. Change from Baseline was summarized using LOCF approaches.
Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)	Baseline, 12 and 24 Months	PAS SFI consists of three questions each with a range of 0 (Big Problem) to 4 (No Problem). PAS SFI was administered at screening, Baseline and at each month 12 and 24. The total PSI is the sum of the three questions; the total score range is 0 to 12. Change from Baseline PAS SFI at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline PAS SFI. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants in a Hospital Ward	Up to 24 Months	Details of number of participants in different types of wards was recorded. Types of wards included general ward, recovery, intensive care unit, multiple ward types and others
Number of Participants With Hospital Admissions	Up to 24 Months	Details of participants who were admitted to hospitals related to AUR or BPH-Related surgery has been recorded.
Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)	Up to 24 Months	An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation that is medically important, All events of possible drug-induced liver injury with hyperbilirubinaemia, male breast cancer and spontaneous abortion of a female partner of a male subject
Change From Baseline in Serum Prostate Specific Antigen (PSA)	Baseline 6, 12 and 24 Months	Total serum PSA concentrations were assessed at pre-screening, month 6, 12 and 24. Change from baseline total PSA was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment at each scheduled post-baseline assessment using a general linear model with effects for treatment and baseline total PSA. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants With Vital Signs Exceeding Threshold Values	Up to 24 Months	Vital signs included assessment of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. Threshold ranges for SBP ranged from \< 80 mmHg (millimeter of mercury) (lower) to \> 165 mmHg (upper); for DBP ranged from \< 40 mmHg (lower) to \> 105 mmHg (upper) and heart rate \< 40 beats per minute (bpm) (lower) to \> 100 bpm (upper).
Change From Baseline in Post Void Residual Volume	Baseline, 6, 12, 18 and 24 Months	Post void residual volume was measured suprapubically by ultrasound (immediately following the urinary flow measurement). Post void residual volume change from Baseline distribution at each scheduled post-Baseline assessment was compared with combination treatment (Dut plus Tam) versus tamsulosin treatment using a nonparametric van Elteren test. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants With Threshold Hematology Value.	Up to 24 Months	The threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal (ULN) range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal (LLN) range is considered a low threshold value. Hematology laboratory parameters assessed included hemoglobin (Hgb), platelet count, white blood cell count (WBC) and red blood cell (RBC) count. Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants With Threshold Clinical Chemistry Value.	Up to 24 Months	Clinical chemistry laboratory parameters assessed included albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatinine, glucose, potassium, sodium, total bilirubin, total protein and urea/blood urea nitrogen (BUN). Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants With Digital Rectal Examination (DRE)	6, 12, 18 , 24 months and final assessment	DRE evaluation was carried out from normal/diffusely enlarged at Baseline to focal abnormalities at any time post-Baseline. DRE was assessed at screening visit, Month 6, 12, 18 , 24 and final assessment is the latest post-Baseline evaluation that was available. Here, participants with focal abnormalities are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants With Clinically Significant Qualitative Breast Examination	6, 12, 18 , 24 months and final assessment	Qualitative breast examination included palpable breast tissue and nipple tenderness. Here, participants with clinically significant abnormalities for palpable breast tissue and nipple tenderness are summarized. Qualitative breast examination was done at screening visit, Month 6, 12, 18 , 24 and final assessment (latest post-Baseline evaluation that was available). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Participants With Suicidal Ideation and Suicidal Behavior	6, 12, 18 , 24 months and final assessment	Suicidality was assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS). It included tabular summaries of suicidal ideation and suicidal behavior questions that were administered. Assessments were carried out at Screening, Month 6, Month 12, and Month 24 (or end of treatment) visits. C-SSRS included Question1-2 were for suicidal ideation Question 1: Passive: wish to be dead, Question 2: Active: Non-specific (no method, intent or plan). Questions 6-10 were for suicidal behavior, Question 6: Preparatory Acts or Behavior, Question 7: any aborted attempt, Question 8: Any interrupted attempts, Question 9: Any non-fatal actual suicide attempt, Question 10: Completed suicide. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
Number of Hospitalization Days	Up to 24 Months	Duration of hospitalization days due to AUR or BPH-related surgery was recorded.

Countries

China, Japan, South Korea, Taiwan

Participant flow

Recruitment details

A randomized, double-blind, parallel group trial to assess the effectiveness and safety of dutasteride (Dut) 0.5 milligram (mg) and tamsulosin (Tam) 0.2 mg combination compared to Tam 0.2 mg. The study consisted of a single-blind, placebo run-in, followed by a 2 year treatment. Eligible subjects were randomized to Dut + Tam or Dut placebo + Tam

Pre-assignment details

Six hundred and fifty moderate to severe benign prostatic hyperplasia (BPH) subjects were screened with 607 participants receiving as least one dose of the study medication (China 243, Japan 135, Korea 181, Taiwan 48). Five hundred and twelve subjects completed the study with 95 subjects withdrawn.

Participants by arm

Arm	Count
Placebo + Tam 0.2mg Participants were randomized in a ratio of 1:1 to receive Dut placebo QD plus Tam 0.2 mg QD for 104 Weeks.	302
Dut 0.5 mg + Tam 0.2 mg Participants were randomized in a ratio of 1:1 to receive Dut 0.5 mg QD plus Tam 0.2 mg QD for 104 Weeks.	305
Total	607

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	15	20
Overall Study	Lack of Efficacy	0	1
Overall Study	Lost to Follow-up	2	0
Overall Study	Physician Decision	2	3
Overall Study	Protocol Violation	0	4
Overall Study	Withdrawal by Subject	22	26

Baseline characteristics

Characteristic	Placebo + Tam 0.2mg	Dut 0.5 mg + Tam 0.2 mg	Total
Age, Continuous	66.2 Years STANDARD_DEVIATION 6.85	66.8 Years STANDARD_DEVIATION 6.82	66.5 Years STANDARD_DEVIATION 6.84
Race/Ethnicity, Customized Asian - East Asian Heritage	234 Participants	236 Participants	470 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	68 Participants	67 Participants	135 Participants
Race/Ethnicity, Customized Asian - Southeast Asian Heritage	0 Participants	2 Participants	2 Participants
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	302 Participants	305 Participants	607 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 302	2 / 305
other Total, other adverse events	203 / 302	208 / 305
serious Total, serious adverse events	52 / 302	49 / 305

Outcome results

Primary

Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months

IPSS (also called IPSS total score) is the sum of the seven questions with each score ranging from 0 (best) to 5 (worst). IPSS was self administered at screening, Baseline and each time-point of Month 3, 6, 9, 12, 15, 18, 21 and 24. Seven questions included are incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. The total IPSS score can range from 0-35 with severity catagories of mild (0 to 7), moderate (8 to 19) or severe (20 to 35). LOCF is defined as carrying forward the last non-missing post-Baseline assessment for participants with missing visit data and/or for participants who discontinued from the study. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Month 24 is the primary timepoint and earlier timepoints are considered secondary. Change from Baseline defined as difference between Post-Baseline value and Baseline value.

Time frame: Baseline and 3, 6, 9, 12, 15, 18, 21 and 24 months

Population: ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo + Tam 0.2mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 3, n=299, 296	-4.07 Score on scale	Standard Error 0.34
Placebo + Tam 0.2mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 6, n=300, 298	-3.73 Score on scale	Standard Error 0.37
Placebo + Tam 0.2mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 9, n=300, 298	-4.14 Score on scale	Standard Error 0.36
Placebo + Tam 0.2mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 12,n= 300, 298	-3.93 Score on scale	Standard Error 0.36
Placebo + Tam 0.2mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 15, n=300, 298	-3.95 Score on scale	Standard Error 0.36
Placebo + Tam 0.2mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 18, n=300, 298	-3.84 Score on scale	Standard Error 0.38
Placebo + Tam 0.2mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 21, n=300, 298	-3.94 Score on scale	Standard Error 0.38
Placebo + Tam 0.2mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 24, n=300, 298	-3.53 Score on scale	Standard Error 0.39
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 24, n=300, 298	-4.96 Score on scale	Standard Error 0.39
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 3, n=299, 296	-3.28 Score on scale	Standard Error 0.34
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 15, n=300, 298	-4.90 Score on scale	Standard Error 0.36
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 6, n=300, 298	-3.36 Score on scale	Standard Error 0.37
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 21, n=300, 298	-4.66 Score on scale	Standard Error 0.38
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 9, n=300, 298	-4.28 Score on scale	Standard Error 0.36
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 18, n=300, 298	-4.54 Score on scale	Standard Error 0.38
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months	Month 12,n= 300, 298	-4.30 Score on scale	Standard Error 0.36

p-value: 0.06995% CI: [-0.06, 1.65]General linear model

p-value: 0.4395% CI: [-0.55, 1.29]General linear model

p-value: 0.7695% CI: [-1.05, 0.77]General linear model

p-value: 0.4195% CI: [-1.27, 0.53]General linear model

p-value: 0.03995% CI: [-1.85, -0.05]General linear model

p-value: 0.1595% CI: [-1.65, 0.26]General linear model

p-value: 0.1595% CI: [-1.68, 0.25]General linear model

p-value: 0.00495% CI: [-2.4, -0.46]General linear model

Secondary

Change From Baseline in BPH Impact Index (BII) by LOCF Approach

The BII consists of four questions and BII total score is the sum of four questions. Total score range is 0 (no problem) to 13 (worst value). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline BII at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BII. Change from Baseline was summarized using LOCF approaches.

Time frame: Baseline 3, 6, 9, 12, 15, 18, 21 and 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo + Tam 0.2mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 9, n=300, 298	-1.55 Scores on scale	Standard Error 0.15
Placebo + Tam 0.2mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 18, n=300, 298	-1.16 Scores on scale	Standard Error 0.16
Placebo + Tam 0.2mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 6, n=300, 298	-1.28 Scores on scale	Standard Error 0.15
Placebo + Tam 0.2mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 21, n=300, 298	-1.12 Scores on scale	Standard Error 0.17
Placebo + Tam 0.2mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 12, n=300, 298	-1.39 Scores on scale	Standard Error 0.16
Placebo + Tam 0.2mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 24, n=300, 298	-1.02 Scores on scale	Standard Error 0.17
Placebo + Tam 0.2mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 15, n=300, 298	-1.30 Scores on scale	Standard Error 0.16
Placebo + Tam 0.2mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 3, n=299, 296	-1.48 Scores on scale	Standard Error 0.14
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 12, n=300, 298	-1.24 Scores on scale	Standard Error 0.16
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 3, n=299, 296	-1.23 Scores on scale	Standard Error 0.14
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 6, n=300, 298	-1.08 Scores on scale	Standard Error 0.16
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 9, n=300, 298	-1.26 Scores on scale	Standard Error 0.16
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 15, n=300, 298	-1.41 Scores on scale	Standard Error 0.16
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 18, n=300, 298	-1.28 Scores on scale	Standard Error 0.16
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 21, n=300, 298	-1.27 Scores on scale	Standard Error 0.17
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in BPH Impact Index (BII) by LOCF Approach	Month 24, n=300, 298	-1.48 Scores on scale	Standard Error 0.17

p-value: 0.1795% CI: [-0.11, 0.62]General linear model

p-value: 0.3395% CI: [-0.2, 0.59]General linear model

p-value: 0.1595% CI: [-0.1, 0.68]General linear model

p-value: 0.4695% CI: [-0.25, 0.55]General linear model

p-value: 0.5995% CI: [-0.51, 0.29]General linear model

p-value: 0.5695% CI: [-0.52, 0.28]General linear model

p-value: 0.5195% CI: [-0.56, 0.28]General linear model

p-value: 0.03495% CI: [-0.88, -0.03]General linear model

Secondary

Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach

Qmax is defined as maximum urine flow. Qmax was measured with Uroflow meter (Urodyn 1000) at Screening, Baseline, and at Months 6,12,18 and 24. Change from Baseline Qmax at each scheduled post-Baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline Qmax. Baseline value was defined as the latest non-missing assessment either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: Baseline, 6, 12, 18 and 24 Months

Population: ITT Population

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo + Tam 0.2mg	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Month 6, n=270, 274	0.62 milliliter per second (mL/sec)	Standard Error 0.26
Placebo + Tam 0.2mg	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Month 12, n=286, 287	0.63 milliliter per second (mL/sec)	Standard Error 0.28
Placebo + Tam 0.2mg	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Month 18, n=287, 288	0.90 milliliter per second (mL/sec)	Standard Error 0.33
Placebo + Tam 0.2mg	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Month 24, n=287,290	0.93 milliliter per second (mL/sec)	Standard Error 0.32
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Month 24, n=287,290	2.27 milliliter per second (mL/sec)	Standard Error 0.32
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Month 6, n=270, 274	1.54 milliliter per second (mL/sec)	Standard Error 0.26
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Month 18, n=287, 288	2.36 milliliter per second (mL/sec)	Standard Error 0.33
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach	Month 12, n=286, 287	1.62 milliliter per second (mL/sec)	Standard Error 0.27

p-value: 0.00695% CI: [0.26, 1.56]General linear model

p-value: 0.00595% CI: [0.3, 1.69]General linear model

p-value: <0.00195% CI: [0.63, 2.29]General linear model

p-value: 0.00195% CI: [0.54, 2.15]General linear model

Secondary

Change From Baseline in Post Void Residual Volume

Post void residual volume was measured suprapubically by ultrasound (immediately following the urinary flow measurement). Post void residual volume change from Baseline distribution at each scheduled post-Baseline assessment was compared with combination treatment (Dut plus Tam) versus tamsulosin treatment using a nonparametric van Elteren test. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: Baseline, 6, 12, 18 and 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo + Tam 0.2mg	Change From Baseline in Post Void Residual Volume	Month 6, n=288, 290	-4.8 mL	Standard Deviation 52.59
Placebo + Tam 0.2mg	Change From Baseline in Post Void Residual Volume	Month 12, n=291, 292	1.5 mL	Standard Deviation 60.94
Placebo + Tam 0.2mg	Change From Baseline in Post Void Residual Volume	Month 18, n=291, 292	-2.6 mL	Standard Deviation 55.67
Placebo + Tam 0.2mg	Change From Baseline in Post Void Residual Volume	Month 24, n=291, 292	2.6 mL	Standard Deviation 64.71
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Post Void Residual Volume	Month 24, n=291, 292	-2.6 mL	Standard Deviation 62.01
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Post Void Residual Volume	Month 6, n=288, 290	-3.0 mL	Standard Deviation 59.56
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Post Void Residual Volume	Month 18, n=291, 292	-1.3 mL	Standard Deviation 63.98
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Post Void Residual Volume	Month 12, n=291, 292	-1.4 mL	Standard Deviation 59.19

p-value: 0.77Van Elteren test

p-value: 0.84Van Elteren test

p-value: 0.98Van Elteren test

p-value: 0.28Van Elteren test

Secondary

Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)

PAS SFI consists of three questions each with a range of 0 (Big Problem) to 4 (No Problem). PAS SFI was administered at screening, Baseline and at each month 12 and 24. The total PSI is the sum of the three questions; the total score range is 0 to 12. Change from Baseline PAS SFI at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline PAS SFI. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: Baseline, 12 and 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo + Tam 0.2mg	Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)	Month 12, n=291, 293	0.11 Scores on scale	Standard Deviation 0.21
Placebo + Tam 0.2mg	Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)	Month 24, n=291, 294	-0.11 Scores on scale	Standard Deviation 0.21
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)	Month 12, n=291, 293	-0.91 Scores on scale	Standard Deviation 0.2
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)	Month 24, n=291, 294	-0.82 Scores on scale	Standard Deviation 0.21

p-value: <0.00195% CI: [-1.54, -0.5]General linear model

p-value: 0.00995% CI: [-1.23, -0.18]General linear model

Secondary

Change From Baseline in Serum Prostate Specific Antigen (PSA)

Total serum PSA concentrations were assessed at pre-screening, month 6, 12 and 24. Change from baseline total PSA was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment at each scheduled post-baseline assessment using a general linear model with effects for treatment and baseline total PSA. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: Baseline 6, 12 and 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo + Tam 0.2mg	Change From Baseline in Serum Prostate Specific Antigen (PSA)	Month 6, n=292, 294	0.2 nanogram/milliliter (ng/mL)	Standard Deviation 0.09
Placebo + Tam 0.2mg	Change From Baseline in Serum Prostate Specific Antigen (PSA)	Month 12, n=293, 294	0.2 nanogram/milliliter (ng/mL)	Standard Deviation 0.08
Placebo + Tam 0.2mg	Change From Baseline in Serum Prostate Specific Antigen (PSA)	Month 24, n=293, 295	0.7 nanogram/milliliter (ng/mL)	Standard Deviation 0.16
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Serum Prostate Specific Antigen (PSA)	Month 6, n=292, 294	-1.7 nanogram/milliliter (ng/mL)	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Serum Prostate Specific Antigen (PSA)	Month 12, n=293, 294	-1.9 nanogram/milliliter (ng/mL)	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in Serum Prostate Specific Antigen (PSA)	Month 24, n=293, 295	-2.0 nanogram/milliliter (ng/mL)	Standard Deviation 0.16

p-value: <0.00195% CI: [-2.1, -1.6]General linear model

p-value: <0.00195% CI: [-2.3, -1.9]General linear model

p-value: <0.00195% CI: [-3.1, -2.2]General linear model

Secondary

Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach

BHS was collected as Question 8 the IPSS questionnaire regarding quality of life due to urinary symptom with scores values ranging from 0 (delightful) to 6 (terrible). Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from baseline BHS at each scheduled post-baseline assessment was compared in terms of combination treatment (Dut plus Tam) versus tamsulosin treatment using t-tests from a general linear model with effects for treatment, country, and Baseline BHS.

Time frame: Baseline, 3, 6, 9, 12, 15, 18, 21 and 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo + Tam 0.2mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 3, n=299, 296	-0.88 Scores on scale	Standard Deviation 0.08
Placebo + Tam 0.2mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 6, n=300,298	-0.89 Scores on scale	Standard Deviation 0.08
Placebo + Tam 0.2mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 9, n=300, 298	-1.08 Scores on scale	Standard Deviation 0.08
Placebo + Tam 0.2mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 12, n=300, 298	-0.87 Scores on scale	Standard Deviation 0.08
Placebo + Tam 0.2mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 15, n=300, 298	-0.93 Scores on scale	Standard Deviation 0.08
Placebo + Tam 0.2mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 18, n=300, 298	-0.92 Scores on scale	Standard Deviation 0.08
Placebo + Tam 0.2mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 21, n=300, 298	-1.08 Scores on scale	Standard Deviation 0.09
Placebo + Tam 0.2mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 24, n=300, 298	-1.00 Scores on scale	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 24, n=300, 298	-1.16 Scores on scale	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 3, n=299, 296	-0.85 Scores on scale	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 15, n=300, 298	-1.02 Scores on scale	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 6, n=300,298	-0.73 Scores on scale	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 21, n=300, 298	-1.02 Scores on scale	Standard Deviation 0.09
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 9, n=300, 298	-0.95 Scores on scale	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 18, n=300, 298	-1.00 Scores on scale	Standard Deviation 0.08
Dut 0.5 mg + Tam 0.2 mg	Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach	Month 12, n=300, 298	-0.90 Scores on scale	Standard Deviation 0.08

p-value: 0.8395% CI: [-0.17, 0.21]General linear model

p-value: 0.1195% CI: [-0.04, 0.36]General linear model

p-value: 0.2195% CI: [-0.07, 0.34]General linear model

p-value: 0.895% CI: [-0.23, 0.18]General linear model

p-value: 0.3795% CI: [-0.3, 0.11]General linear model

p-value: 0.4495% CI: [-0.3, 0.13]General linear model

p-value: 0.695% CI: [-0.16, 0.28]General linear model

p-value: 0.1695% CI: [-0.37, 0.06]General linear model

Secondary

Number of Hospitalization Days

Duration of hospitalization days due to AUR or BPH-related surgery was recorded.

Time frame: Up to 24 Months

Population: ITT Population. Only those participants with data available at specific time point were analyzed

Arm	Measure	Value (MEDIAN)
Placebo + Tam 0.2mg	Number of Hospitalization Days	10.0 Days
Dut 0.5 mg + Tam 0.2 mg	Number of Hospitalization Days	9.0 Days

Secondary

Number of Participants in a Hospital Ward

Details of number of participants in different types of wards was recorded. Types of wards included general ward, recovery, intensive care unit, multiple ward types and others

Time frame: Up to 24 Months

Population: ITT Population. Only those participants with data available at specific time point were analyzed

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants in a Hospital Ward	General ward	2 Participants
Placebo + Tam 0.2mg	Number of Participants in a Hospital Ward	Recovery	0 Participants
Placebo + Tam 0.2mg	Number of Participants in a Hospital Ward	Other	1 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants in a Hospital Ward	General ward	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants in a Hospital Ward	Recovery	1 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants in a Hospital Ward	Other	0 Participants

Secondary

Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery

AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization. AUR or BPH-related surgery event details per participant was summarized as first occurring of either AUR or BPH-related surgery.

Time frame: Up to 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Overall	15 Participants
Placebo + Tam 0.2mg	Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Year 1 subset	8 Participants
Placebo + Tam 0.2mg	Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Year 2 subset	7 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Overall	4 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Year 1 subset	2 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery	Year 2 subset	2 Participants

p-value: 0.01295% CI: [0.09, 0.81]Log Rank

Secondary

Number of Participants With BPH-related Surgery

BPH-related interventions were recorded. BPH-related interventions included adenomectomy, balloon dilatation, electroresection, thermotherapy (microwave or radiofrequency), laser resection, prostatectomy, prostatotomy, transurethral resection of the prostate, transurethral drainage of prostatic abscess, drainage of prostatic cysts, radioactive seeding of the prostate, prostatic urethral stenting, incision of periurethral stricture, ethanol injections into the prostate, transrectal high intensity focussed ultrasound, transurethral needle ablation and transurethral microwave thermotherapy.

Time frame: Up to 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With BPH-related Surgery	Overall	3 Participants
Placebo + Tam 0.2mg	Number of Participants With BPH-related Surgery	Year 1 subset	0 Participants
Placebo + Tam 0.2mg	Number of Participants With BPH-related Surgery	Year 2 subset	3 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With BPH-related Surgery	Overall	2 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With BPH-related Surgery	Year 1 subset	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With BPH-related Surgery	Year 2 subset	2 Participants

p-value: 0.6895% CI: [0.11, 4.11]Log Rank

Secondary

Number of Participants With Clinically Significant Qualitative Breast Examination

Qualitative breast examination included palpable breast tissue and nipple tenderness. Here, participants with clinically significant abnormalities for palpable breast tissue and nipple tenderness are summarized. Qualitative breast examination was done at screening visit, Month 6, 12, 18 , 24 and final assessment (latest post-Baseline evaluation that was available). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: 6, 12, 18 , 24 months and final assessment

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue, Month 6, n=289, 284	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness,Month 6, n=289, 284	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue, Month 12, n=279, 273	1 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness,Month 12, n=279, 273	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue, Month 18, n=267, 258	1 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness,Month 18, n=267, 258	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue, Month 24, n=262, 252	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness, Month 24, n=262, 252	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue,final assessment, n=296,296	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness,final assessment, n=296, 296	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness, Month 24, n=262, 252	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue, Month 6, n=289, 284	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness,Month 18, n=267, 258	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness,Month 6, n=289, 284	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness,final assessment, n=296, 296	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue, Month 12, n=279, 273	2 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue, Month 24, n=262, 252	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Nipple tenderness,Month 12, n=279, 273	1 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue,final assessment, n=296,296	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Clinically Significant Qualitative Breast Examination	Palpable breast tissue, Month 18, n=267, 258	0 Participants

Secondary

Number of Participants With Digital Rectal Examination (DRE)

DRE evaluation was carried out from normal/diffusely enlarged at Baseline to focal abnormalities at any time post-Baseline. DRE was assessed at screening visit, Month 6, 12, 18 , 24 and final assessment is the latest post-Baseline evaluation that was available. Here, participants with focal abnormalities are summarized. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: 6, 12, 18 , 24 months and final assessment

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Digital Rectal Examination (DRE)	Month 12, n=279, 272	10 Participants
Placebo + Tam 0.2mg	Number of Participants With Digital Rectal Examination (DRE)	Month 24, n=261, 252	10 Participants
Placebo + Tam 0.2mg	Number of Participants With Digital Rectal Examination (DRE)	Month 18, n=267, 258	6 Participants
Placebo + Tam 0.2mg	Number of Participants With Digital Rectal Examination (DRE)	Final Assessment, n=296, 295	10 Participants
Placebo + Tam 0.2mg	Number of Participants With Digital Rectal Examination (DRE)	Month 6, n=287, 285	11 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Digital Rectal Examination (DRE)	Final Assessment, n=296, 295	15 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Digital Rectal Examination (DRE)	Month 6, n=287, 285	9 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Digital Rectal Examination (DRE)	Month 12, n=279, 272	11 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Digital Rectal Examination (DRE)	Month 18, n=267, 258	12 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Digital Rectal Examination (DRE)	Month 24, n=261, 252	13 Participants

Secondary

Number of Participants With Hospital Admissions

Details of participants who were admitted to hospitals related to AUR or BPH-Related surgery has been recorded.

Time frame: Up to 24 Months

Population: ITT Population. Only those participants with data available at specific time point were analyzed.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Hospital Admissions	In-patient	6 Participants
Placebo + Tam 0.2mg	Number of Participants With Hospital Admissions	Out-patient	5 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Hospital Admissions	Out-patient	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Hospital Admissions	In-patient	3 Participants

Secondary

Number of Participants With IPSS Improvement From Baseline

Improvement in IPSS was categorized as improvement, no change and worsening. Improvement defined as greater than or equal to 2 points, greater than or equal to 3 points and greater than or equal to 25 percent in participants at months 3,6,9,12,15,18,21 and 24 . Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value.

Time frame: Baseline and 3, 6, 9,12,15,18,21 and 24 months

Population: ITT Population.

Arm	Measure	Group	Value (NUMBER)
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 9,>= 3 units, n=300, 298	157 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 3,>= 2 units, n=299,296	190 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 3,>= 25percent, n=299, 296	134 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 6,>= 3 units, n=300, 298	156 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 6,>= 2 units, n=300, 298	179 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 6,>= 25percent, n=300, 298	131 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 3,>= 3 units, n=299, 296	160 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 15,>= 3 units, n=300, 298	171 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 9,>= 2 units, n=300, 298	185 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 9,>= 25percent, n=300, 298	128 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 12,>= 3 units, n=300, 298	154 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 12,>= 2 units, n=300, 298	179 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 12,>= 25percent, n=300, 298	131 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 15,>= 2 units, n=300, 298	186 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 15,>= 25percent, n=300, 298	133 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 18,>= 3 units, n=300, 298	156 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 18,>= 2 units, n=300, 298	173 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 18,>= 25percent, n=300, 298	136 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 21,>= 3 units, n=300, 298	169 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 21,>= 2 units, n=300, 298	186 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 21,>= 25percent, n=300, 298	141 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 24,>= 3 units, n=300, 298	156 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 24,>= 2 units, n=300, 298	175 Participants
Placebo + Tam 0.2mg	Number of Participants With IPSS Improvement From Baseline	Month 24,>= 25percent, n=300, 298	137 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 12,>= 25percent, n=300, 298	154 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 3,>= 3 units, n=299, 296	157 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 15,>= 3 units, n=300, 298	186 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 3,>= 2 units, n=299,296	176 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 24,>= 25percent, n=300, 298	169 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 3,>= 25percent, n=299, 296	123 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 21,>= 2 units, n=300, 298	194 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 6,>= 3 units, n=300, 298	156 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 15,>= 25percent, n=300, 298	160 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 6,>= 2 units, n=300, 298	176 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 24,>= 2 units, n=300, 298	197 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 6,>= 25percent, n=300, 298	133 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 18,>= 3 units, n=300, 298	171 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 21,>= 25percent, n=300, 298	161 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 9,>= 3 units, n=300, 298	177 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 18,>= 2 units, n=300, 298	187 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 9,>= 2 units, n=300, 298	193 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 15,>= 2 units, n=300, 298	203 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 9,>= 25percent, n=300, 298	150 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 18,>= 25percent, n=300, 298	148 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 12,>= 3 units, n=300, 298	171 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 24,>= 3 units, n=300, 298	184 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 12,>= 2 units, n=300, 298	191 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With IPSS Improvement From Baseline	Month 21,>= 3 units, n=300, 298	178 Participants

p-value: 0.91Mantel Haenszel

p-value: 0.31Mantel Haenszel

p-value: 0.42Mantel Haenszel

p-value: 0.92Mantel Haenszel

p-value: 0.89Mantel Haenszel

p-value: 0.81Mantel Haenszel

p-value: 0.08Mantel Haenszel

p-value: 0.42Mantel Haenszel

p-value: 0.06Mantel Haenszel

p-value: 0.14Mantel Haenszel

p-value: 0.26Mantel Haenszel

p-value: 0.048Mantel Haenszel

p-value: 0.17Mantel Haenszel

p-value: 0.11Mantel Haenszel

p-value: 0.022Mantel Haenszel

p-value: 0.18Mantel Haenszel

p-value: 0.19Mantel Haenszel

p-value: 0.28Mantel Haenszel

p-value: 0.39Mantel Haenszel

p-value: 0.42Mantel Haenszel

p-value: 0.084Mantel Haenszel

p-value: 0.016Mantel Haenszel

p-value: 0.047Mantel Haenszel

p-value: 0.007Mantel Haenszel

Secondary

Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)

An adverse event is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as resulting in death, life threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation that is medically important, All events of possible drug-induced liver injury with hyperbilirubinaemia, male breast cancer and spontaneous abortion of a female partner of a male subject

Time frame: Up to 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)	Any Non-serious AE	203 Participants
Placebo + Tam 0.2mg	Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)	Any SAE	52 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)	Any Non-serious AE	208 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)	Any SAE	49 Participants

Secondary

Number of Participants With Qmax Improvement From Baseline by LOCF Approach.

Qmax change from Baseline was presented using six improvement levels: \>0 milliliter per second (mL/sec) and \>=1 mL/sec through \>=5mL/sec. Qmax percentage change from Baseline was presented using six improvement levels: \>0%, \>=10%, \>=20%, \>=30%, \>=40%, and \>=50%. Here, Qmax improvement of \>= 3 mL/sec and Qmax percentage of \>= 30 % for 24 Months has been summarized. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline defined as difference between Post-Baseline value and Baseline value. Baseline value is defined as the latest non-missing assessment of either treatment start date or randomization date.

Time frame: Baseline 6, 12, 18 and 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 6, >= 3 mL/sec, n=270, 274	69 Participants
Placebo + Tam 0.2mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 6, >= 3 %, n=270, 274	70 Participants
Placebo + Tam 0.2mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 12, >= 3 mL/sec, n=286, 287	64 Participants
Placebo + Tam 0.2mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 12, >= 3 %, n=286, 287	73 Participants
Placebo + Tam 0.2mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 18, >= 3 mL/sec, n=287, 288	80 Participants
Placebo + Tam 0.2mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 18, >= 3 %, n= 287, 288	81 Participants
Placebo + Tam 0.2mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 24, >= 3 mL/sec, n=287, 290	77 Participants
Placebo + Tam 0.2mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 24, >= 30 %, n=287, 290	71 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 24, >= 30 %, n=287, 290	119 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 6, >= 3 mL/sec, n=270, 274	86 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 18, >= 3 mL/sec, n=287, 288	115 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 6, >= 3 %, n=270, 274	86 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 24, >= 3 mL/sec, n=287, 290	121 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 12, >= 3 mL/sec, n=286, 287	102 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 18, >= 3 %, n= 287, 288	111 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Qmax Improvement From Baseline by LOCF Approach.	Month 12, >= 3 %, n=286, 287	107 Participants

p-value: 0.13Mantel Haenszel

p-value: 0.15Mantel Haenszel

p-value: <0.001Mantel Haenszel

p-value: 0.003Mantel Haenszel

p-value: 0.002Mantel Haenszel

p-value: 0.009Mantel Haenszel

p-value: <0.001Mantel Haenszel

Secondary

Number of Participants With Suicidal Ideation and Suicidal Behavior

Suicidality was assessed utilizing the Columbia Suicide Severity Rating Scale (C-SSRS). It included tabular summaries of suicidal ideation and suicidal behavior questions that were administered. Assessments were carried out at Screening, Month 6, Month 12, and Month 24 (or end of treatment) visits. C-SSRS included Question1-2 were for suicidal ideation Question 1: Passive: wish to be dead, Question 2: Active: Non-specific (no method, intent or plan). Questions 6-10 were for suicidal behavior, Question 6: Preparatory Acts or Behavior, Question 7: any aborted attempt, Question 8: Any interrupted attempts, Question 9: Any non-fatal actual suicide attempt, Question 10: Completed suicide. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: 6, 12, 18 , 24 months and final assessment

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 24, Suicidal ideation, Q1, n=261, 251	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q8, n=289, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 24, Suicidal ideation, Q2, n=261, 251	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal ideation, Q2, n=279, 273	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q6, n=261, 251	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal ideation, Q2, n=289, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q7, n=261, 251	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q6, n=279, 273	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q8, n=261, 251	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q9, n=289, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q9, n=261, 251	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q7, n=279, 273	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q10, n=261, 251	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q7, n=289, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal ideation,Q1, n=288, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q8, n=279, 273	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal ideation,Q2, n=288, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q10, n=289, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q6, n=288, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q9, n=279, 273	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q7, n=288, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q6, n=289, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q8, n=288, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q10, n=279, 273	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q9, n=288, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal ideation, Q1, n=279, 273	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q10,n=288, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal ideation, Q1, n=289, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q10,n=288, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal ideation, Q1, n=289, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal ideation, Q2, n=289, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q6, n=289, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q7, n=289, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q8, n=289, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q9, n=289, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 6, Suicidal behavior, Q10, n=289, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal ideation, Q1, n=279, 273	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal ideation, Q2, n=279, 273	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q6, n=279, 273	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q7, n=279, 273	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q8, n=279, 273	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q9, n=279, 273	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q10, n=279, 273	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 24, Suicidal ideation, Q1, n=261, 251	1 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 24, Suicidal ideation, Q2, n=261, 251	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q6, n=261, 251	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q7, n=261, 251	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q8, n=261, 251	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q9, n=261, 251	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Month 12, Suicidal behavior, Q10, n=261, 251	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal ideation,Q1, n=288, 285	1 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal ideation,Q2, n=288, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q6, n=288, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q7, n=288, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q8, n=288, 285	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Suicidal Ideation and Suicidal Behavior	Final assessment, Suicidal behavior,Q9, n=288, 285	0 Participants

Secondary

Number of Participants With Threshold Clinical Chemistry Value.

Clinical chemistry laboratory parameters assessed included albumin, alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST), creatinine, glucose, potassium, sodium, total bilirubin, total protein and urea/blood urea nitrogen (BUN). Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: Up to 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	albumin, <0.90 X LLN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	albumin, >1.20 X ULN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	ALT, >3.00 X ULN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	ALP, > 1.50 X ULN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	AST, >3.00 X ULN, n=288, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	creatinine, <0.50 X LLN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	creatinine, >3.00 X ULN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	glucose, <0.70 X LLN, n=288, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	glucose, >1.75 X ULN, n=280, 285	13 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	potassium, <0.75 X LLN, n=288, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	potassium, >1.40 X ULN, n=288, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	sodium, <0.90 X LLN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	sodium, >1.15 X ULN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	total bilirubin, >2.50 X ULN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	total protein, <0.80 X LLN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	total protein, >1.15 X ULN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	Urea/BUN, <0.50 X LLN, n=289, 292	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Clinical Chemistry Value.	Urea/BUN, >2.00 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	total bilirubin, >2.50 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	albumin, <0.90 X LLN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	potassium, <0.75 X LLN, n=288, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	albumin, >1.20 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	Urea/BUN, >2.00 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	ALT, >3.00 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	potassium, >1.40 X ULN, n=288, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	ALP, > 1.50 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	total protein, <0.80 X LLN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	AST, >3.00 X ULN, n=288, 292	1 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	sodium, <0.90 X LLN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	creatinine, <0.50 X LLN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	Urea/BUN, <0.50 X LLN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	creatinine, >3.00 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	sodium, >1.15 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	glucose, <0.70 X LLN, n=288, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	total protein, >1.15 X ULN, n=289, 292	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Clinical Chemistry Value.	glucose, >1.75 X ULN, n=280, 285	13 Participants

Secondary

Number of Participants With Threshold Hematology Value.

The threshold laboratory values are defined in terms of a multiplicative factor of the testing laboratory's normal range. A laboratory value that is above the upper limit factor multiplied by the upper limit of the normal (ULN) range is considered a high threshold value. A laboratory value that is below the lower limit factor multiplied by the lower limit of the normal (LLN) range is considered a low threshold value. Hematology laboratory parameters assessed included hemoglobin (Hgb), platelet count, white blood cell count (WBC) and red blood cell (RBC) count. Threshold factors are in the below table. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.

Time frame: Up to 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Threshold Hematology Value.	Hgb, <0.75 X LLN, n=287, 291	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Hematology Value.	Platelet count, <0.75 X LLN, n=284, 283	6 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Hematology Value.	Platelet count, >1.50 X ULN, n=285, 285	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Hematology Value.	RBC, <0.50 X LLN, n=287, 291	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Hematology Value.	WBC, <0.50 X LLN, n=287, 291	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Threshold Hematology Value.	WBC, >3.00 X ULN, n=287, 291	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Hematology Value.	WBC, <0.50 X LLN, n=287, 291	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Hematology Value.	Hgb, <0.75 X LLN, n=287, 291	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Hematology Value.	RBC, <0.50 X LLN, n=287, 291	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Hematology Value.	Platelet count, <0.75 X LLN, n=284, 283	1 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Hematology Value.	WBC, >3.00 X ULN, n=287, 291	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Threshold Hematology Value.	Platelet count, >1.50 X ULN, n=285, 285	0 Participants

Secondary

Number of Participants With Vital Signs Exceeding Threshold Values

Vital signs included assessment of systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate. Threshold ranges for SBP ranged from \< 80 mmHg (millimeter of mercury) (lower) to \> 165 mmHg (upper); for DBP ranged from \< 40 mmHg (lower) to \> 105 mmHg (upper) and heart rate \< 40 beats per minute (bpm) (lower) to \> 100 bpm (upper).

Time frame: Up to 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	SBP, > 165 mmHg	10 Participants
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	DBP, either threshold	6 Participants
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	DBP, < 40 mmHg	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	Heart rate, < 40 bpm	0 Participants
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	SBP, either threshold	10 Participants
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	Heart rate, > 100 bpm	11 Participants
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	DBP, > 105 mmHg	6 Participants
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	Heart rate, either threshold	11 Participants
Placebo + Tam 0.2mg	Number of Participants With Vital Signs Exceeding Threshold Values	SBP, < 80 mmHg	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	Heart rate, either threshold	14 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	SBP, < 80 mmHg	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	SBP, > 165 mmHg	13 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	SBP, either threshold	13 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	DBP, < 40 mmHg	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	DBP, > 105 mmHg	2 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	DBP, either threshold	2 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	Heart rate, < 40 bpm	0 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Participants With Vital Signs Exceeding Threshold Values	Heart rate, > 100 bpm	14 Participants

Secondary

Number of Subjects With AUR

AUR is defined as condition when the participant is unable to urinate and requires bladder catheterization.

Time frame: Up to 24 Months

Population: ITT Population.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo + Tam 0.2mg	Number of Subjects With AUR	Overall	13 Participants
Placebo + Tam 0.2mg	Number of Subjects With AUR	Year 1 subset	8 Participants
Placebo + Tam 0.2mg	Number of Subjects With AUR	Year 2 subset	5 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Subjects With AUR	Overall	2 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Subjects With AUR	Year 1 subset	2 Participants
Dut 0.5 mg + Tam 0.2 mg	Number of Subjects With AUR	Year 2 subset	0 Participants

p-value: 0.00595% CI: [0.03, 0.68]Log Rank

Secondary

Percent Change in Prostate Volume From Baseline

Prostate Volume measurements were conducted annually using Transrectal ultrasound (TRUS). The following calculation was utilized to assess the prostate volume (cc): pi/6 (Anteroposterior Width multiplied by Cephalocaudal Width multiplied by Transverse Width). Post-Baseline prostate volume was calculated at 12 and 24 months. Baseline value was defined as the latest non-missing assessment of either treatment start date or randomization date. Change from Baseline was reported based on the LOCF. Change from Baseline defined as difference between Post-Baseline value and Baseline value and reported as a percentage.

Time frame: Baseline,12 and 24 months

Population: ITT Population.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo + Tam 0.2mg	Percent Change in Prostate Volume From Baseline	Month 12, n=287, 286	0.2 Cubic centimeters (cc)	Standard Error 1.28
Placebo + Tam 0.2mg	Percent Change in Prostate Volume From Baseline	Month 24, n=287, 286	3.6 Cubic centimeters (cc)	Standard Error 1.45
Dut 0.5 mg + Tam 0.2 mg	Percent Change in Prostate Volume From Baseline	Month 12, n=287, 286	-22.8 Cubic centimeters (cc)	Standard Error 0.99
Dut 0.5 mg + Tam 0.2 mg	Percent Change in Prostate Volume From Baseline	Month 24, n=287, 286	-24.8 Cubic centimeters (cc)	Standard Error 1.06

p-value: <0.00195% CI: [-25.9, -20.1]General linear model

p-value: <0.00195% CI: [-31.7, -25.2]General linear model

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study to Compare the Efficacy and Safety of Combination Treatment With Dutasteride and Tamsulosin With Tamsulosin Monotherapy, in Men With Moderate to Severe Benign Prostatic Hyperplasia

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in International Prostate Symptom Score (IPSS) by Last Observation Carried Forward (LOCF) Approach at 24 Months

Change From Baseline in BPH Impact Index (BII) by LOCF Approach

Change From Baseline in Maximum Urine Flow Rate (Qmax) by LOCF Approach

Change From Baseline in Post Void Residual Volume

Change From Baseline in Problem Assessment Scale of the Sexual Function Inventory (PAS-SFI)

Change From Baseline in Serum Prostate Specific Antigen (PSA)

Change From Baseline in the BPH-related Health Status (BHS) by LOCF Approach

Number of Hospitalization Days

Number of Participants in a Hospital Ward

Number of Participants With Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery

Number of Participants With BPH-related Surgery

Number of Participants With Clinically Significant Qualitative Breast Examination

Number of Participants With Digital Rectal Examination (DRE)

Number of Participants With Hospital Admissions

Number of Participants With IPSS Improvement From Baseline

Number of Participants With Non-serious Adverse Events (AE) and Serious AE (SAE)

Number of Participants With Qmax Improvement From Baseline by LOCF Approach.

Number of Participants With Suicidal Ideation and Suicidal Behavior

Number of Participants With Threshold Clinical Chemistry Value.

Number of Participants With Threshold Hematology Value.

Number of Participants With Vital Signs Exceeding Threshold Values

Number of Subjects With AUR

Percent Change in Prostate Volume From Baseline