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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVHT | Other Identifier | Eli Lilly and Company |
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The primary purpose of this clinical trial is to evaluate the change in the International Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day dosing for 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Tamsulosin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | 5 mg once a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | baseline, 4 and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Jeonju | 561-712 |
There were three periods to this study. Period 1 was a 4-week Screening/Washout Period. 196 subjects screened (45 failures). Period 2 was a 4-week Placebo Run-in Period. Period 3 was a 12-week Treatment Period (151 subjects randomized).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | by mouth once a day |
| FG001 | Tadalafil | 5 mg by mouth once a day |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | once a day |
|
| Tamsulosin | Drug | 0.2 mg once a day |
|
| Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation. | baseline, 4, 8, and 12 weeks |
| Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction. | baseline, 4, 8, and 12 weeks |
| Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia). | baseline, 4, 8, and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit. | baseline, 12 weeks |
| Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3). | 12 weeks |
| Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3). | 12 weeks |
| Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported. | baseline, 12 weeks |
| Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported. | baseline, 12 weeks |
| Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination). | baseline, 12 weeks |
| Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter). | baseline, 12 weeks |
| Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | Vcomp, defined as the volume of voided urine (measured in milliliters [mL]). | baseline, 12 weeks |
| South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kwangju | 501-757 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kyunggi-Do | 425-020 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pusan | 614-735 | South Korea |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Seoul | 140-757 | South Korea |
| Tamsulosin |
0.2 mg by mouth once a day |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | by mouth once a day |
| BG001 | Tadalafil | 5 mg by mouth once a day |
| BG002 | Tamsulosin | 0.2 mg by mouth once a day |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Erectile Dysfunction (ED) | Number | participants |
| ||||||||||||||||
| Duration of Erectile Dysfunction (ED) | Because this measure applies only to participants with ED, the number of participants reported here will be less than the total number of participants in the study. | Number | participants |
| |||||||||||||||
| Etiology of Erectile Dysfunction (ED) | Because this measure applies only to participants with ED, the number of participants reported here will be less than the total number of participants in the study. | Number | participants |
| |||||||||||||||
| Severity of Erectile Dysfunction (ED) | Because this measure applies only to participants with ED, the number of participants reported here will be less than the total number of participants in the study. Severity is determined from the International Index of Erectile Function Scores. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30. Severity is determined based on scores as follows: Severe ED ≤10 Moderate ED 11-16 Mild ED 17-25 No ED >25 | Number | participants |
| |||||||||||||||
| Lower Urinary Tract Symptoms Severity | Severity was assessed through the International Prostate Symptom (IPSS) Total Score. The Total Score was obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for a range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | Number | participants |
| |||||||||||||||
| Postvoid Residual Volume (PRV) | Mean | Standard Deviation | milliliters |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| |||||||||||||||
| Body Mass Index | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/meters squared (kg/m^2) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Total Score | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | Primary analysis was performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 4 Week and 8 Week Endpoints in International Prostate Symptom Score (IPSS) Total Score | The IPSS Total Score is obtained by combining the scores of the responses to 1 through 7 component questions. Each question is scored from 0-5 for an IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | baseline, 4 and 8 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Irritative Subscore | The IPSS storage (irritative) subscore is defined as sum of scores for Questions 2, 4, and 7 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS storage subscore will be reported as missing for that visit. Subscore totals range from 0 to 15; higher scores are indicative of greater irritation. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline, 4, 8, and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Obstructive Subscore | The IPSS voiding (obstructive) subscore is defined as sum of scores for Questions 1, 3, 5, and 6 of the IPSS. If scores for any of these questions are missing for a visit, the IPSS voiding subscore will be reported as missing for that visit. Subscore totals range from 0 to 20; higher scores are indicative of greater obstruction. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline, 4, 8, and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 4, 8, and 12 Week Endpoints in International Prostate Symptom Score (IPSS) - Nocturia Subscore | IPSS Question 7 is used to assess the frequency of nocturia. Scores range from 0 (low frequency of nocturia) to 5 (high frequency of nocturia). | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline, 4, 8, and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BPH-II) | The BPH-BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range of 0 to 13; higher scores represent increased perceived impact of BPH-LUTS on overall health. If scores for any component question were missing for a visit, BPH-BII was reported as missing for that visit. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | baseline, 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Patient Global Impression of Improvement (PGI-I) Combined Categories - Frequencies | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants who indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3). | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Number | participants | 12 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinician Global Impression of Improvement (CGI-I) Combined Categories - Frequencies | Measures clinician's perception of patient improvement of illness at the time of assessment compared with start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Scores were combined to provide number of participants whose clinician indicated they were "worse" (scores of 5, 6, or 7), "no change" (score of 4), or "better" (scores of 1, 2, or 3). | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Number | participants | 12 weeks |
|
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| Secondary | Change From Baseline to 12 Week Endpoint in Total, Waking, and Sleeping Voids (Average Number Per Week) Based on Median as Reported in Patient Voiding Dribble Diary | Patient-completed diary that measures daytime frequency (waking voids) and nocturia (sleeping voids). Average number of waking voids per week, average number of sleeping voids per week, and average number of total voids (sleeping+waking) per week are reported. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | average number per week | baseline, 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Total Urinary Incontinence Episodes Per Week Based on Median as Reported in Patient Voiding Dribble Diary | A patient-completed diary that measures urinary incontinence (UI) (leaks). Number of UI leaks per week are reported. | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | average number per week | baseline, 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Voids With Terminal Micturition Dribble and Post Micturition Dribble Per Week Based on Median as Reported by Patient Voiding Dribble Diary | A patient-completed diary that measures terminal dribble (dribble in the end of urination) and post-micturition dribble (dribble after urination). | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | average number per week | baseline, 12 weeks |
|
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| Secondary | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) and Mean Urine Flow Rate (Qmean) | Qmax: defined as the peak urine flow rate (measured in milliliters per second [mL/second] using a standard calibrated flowmeter); and Qmean, defined as the mean urine flow rate (measured in mL/second using a standard calibrated flowmeter). | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | milliliters per second | baseline, 12 weeks |
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| Secondary | Change From Baseline to 12 Week Endpoint in Uroflowmetry Parameters - Voided Urine Volume (Vcomp) | Vcomp, defined as the volume of voided urine (measured in milliliters [mL]). | Secondary continuous analyses were performed on an intent-to-treat basis. Data from participants with baseline and at least one post-baseline data were used for the analysis. Last observation carried forward. | Posted | Mean | Standard Deviation | milliliters | baseline, 12 weeks |
|
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | by mouth once a day | 0 | 2 | ||||
| EG001 | Tadalafil | 5 mg by mouth once a day | 2 | 4 | ||||
| EG002 | Tamsulosin | 0.2 mg by mouth once a day | 2 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No |
|
| 3 Months to < 6 Months |
|
| 6 Months to < 1 Year |
|
| 1 Year or More |
|
| Organic |
|
| Mixed |
|
| Unknown |
|
| Moderate |
|
| Severe |
|
| Severe (IPSS ≥20) |
|
|
| 0.186 |
P-value for 12 Week Change. Change=Endpoint minus baseline. P-values are from an ANCOVA with effects for treatment, prior alpha blocker use (yes/no), and baseline value, and were not adjusted for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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