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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVHK |
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| Name | Class |
|---|---|
| ICOS Corporation | INDUSTRY |
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The purpose of this study is to evaluate the function of the bladder and urethra during urinary storage or voiding in men with signs and symptoms of benign prostatic hyperplasia treated with either placebo or tadalafil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo |
|
| 2 | Active Comparator | tadalafil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | 20 mg tadalafil tablet taken by mouth once a day for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies | Qmax was measured during free-flow tests using a standard calibrated flow meter. | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies |
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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. | Newport Beach | California | 92660 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo tablet taken by mouth once a day for 12 weeks |
| FG001 | Tadalafil | 20 mg tadalafil tablet taken by mouth once a day for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | Placebo tablet taken by mouth once a day for 12 weeks. |
|
Qave was measured during free-flow tests using a standard calibrated flow meter. |
| Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies | PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization. | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies | Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full). | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies | Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full). | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies | Qmax was measured duirng pressure-flow tests. | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies | Qave was measured during pressure-flow tests. | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies | Vcomp was defined as the volume of voided urine measured during pressure-flow tests. | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies | Max Pdet was defined as the maximum detrusor pressure observed during voiding. | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies | BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder. | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies | BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement). | Baseline and 12 weeks |
| Presence of Involuntary Detrusor Contractions During Bladder Filling | Baseline and 12 weeks |
| Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction | Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint. | Baseline and 12 weeks |
| 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 the 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. | 12 weeks |
| Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests | Laboratory tests that were statistically significant and clinically adverse would be reported for safety. | Baseline and 12 weeks |
| United States |
| 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. | Tarzana | California | 91356 | United States |
| 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. | Middlebury | Connecticut | 06762 | United States |
| 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. | Orlando | Florida | 32803 | United States |
| 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. | Chicago | Illinois | 60611 | United States |
| 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. | Fort Wayne | Indiana | 46825 | United States |
| 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. | Garden City | New York | 11530 | United States |
| 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. | San Antonio | Texas | 78229 | United States |
| 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. | Pátrai | 26500 | Greece |
| 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. | Thessaloniki | 56429 | Greece |
| 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. | Coimbra | 3000-076 | Portugal |
| 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. | Lisbon | 1549-008 | Portugal |
| 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. | Porto | 4200-319 | Portugal |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo tablet taken by mouth once a day for 12 weeks |
| BG001 | Tadalafil | 20 mg tadalafil tablet taken by mouth once a day for 12 weeks |
| BG002 | 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 |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Benign Prostatic Hyperplasia (BPH) Lower Urinary Tract Symptom (LUTS) Severity | Severity was determined by the International Prostate Symptom Score (IPSS)Total. The IPSS is obtained by combining the scores of the responses to the 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. | Number | participants |
| |||||||||||||||
| Bladder Outlet Obstruction Index (BOOI) | BOOI, or bladder outlet obstruction index, which is derived from the equation: pdetQmax-2Qmax (where pdetQmax is detrusor pressure at peak urinary flow rate and Qmax is defined as the peak urine flow rate). | Number | participants |
| |||||||||||||||
| Duration of Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms (BPH LUTS) | Number | participants |
| ||||||||||||||||
| Erectile Dysfunction Severity | This measure is only for participants who have Erectile Dysfunction. | Number | participants |
| |||||||||||||||
| Presence of Erectile Dysfunction | Number | participants |
| ||||||||||||||||
| Previous Alpha-Blocker Therapy | Number | participants |
| ||||||||||||||||
| Previous Therapy for Benign Prostatic Hyperplasia | Number | participants |
| ||||||||||||||||
| Race/Ethnicity | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kilograms/square centimeters (kg/cm^2) |
| ||||||||||||||
| Body Weight | Mean | Standard Deviation | kilograms |
| |||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| |||||||||||||||
| Postvoid Residual Volume by Ultrasound | Mean | Standard Deviation | milliliters |
| |||||||||||||||
| Prostate Specific Antigen (PSA) | Mean | Standard Deviation | nanograms per milliliter |
|
| 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 Detrusor Pressure at Peak Urinary Flow Rate (PdetQmax) | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | centimeters of water (cm H20) | Baseline and 12 weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Free-Flow Studies | Qmax was measured during free-flow tests using a standard calibrated flow meter. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | milliliters per second | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Free-Flow Studies | Qave was measured during free-flow tests using a standard calibrated flow meter. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | millilters per second | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Free-Flow Studies | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | milliliters | Baseline and 12 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Postvoid Residual Volume (PVRcath) Measured During Free-Flow Studies | PVRcath is the volume of urine remaining int he bladder after voiding, measured by catheterization. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | milliliters | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Total Bladder Capacity Measured During Free-Flow Studies | Total bladder capacity was defined as Vcomp + PVRcath (obtained when the bladder was full). | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | milliliters | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Bladder Voiding Efficiency (BVE) Measured During Free-Flow Studies | Bladder voiding efficiency was defined as (Vcomp/total bladder capacity) X 100 (obtained when the bladder was full). | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | milliliters | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow Rate (Qmax) Measured During Pressure-Flow Studies | Qmax was measured duirng pressure-flow tests. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | milliliters per second | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Mean Urinary Flow Rate (Qave) Measured During Pressure-Flow Studies | Qave was measured during pressure-flow tests. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | milliliters per second | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Volume of Voided Urine (Vcomp) Measured During Pressure-Flow Studies | Vcomp was defined as the volume of voided urine measured during pressure-flow tests. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | milliliters | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Maximum Detrusor Pressure (Max Pdet) Measured During Pressure-Flow Studies | Max Pdet was defined as the maximum detrusor pressure observed during voiding. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | centimeters of water (cm H20) | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Bladder Contractility Index (BCI) Measured During Pressure-Flow Studies | BCI was derived from the equation PdetQmax + 5Qmax. Scores: <100 means weak, 100-150 menas normal, >150 means strong. A decrease means a decrease in contractility of the bladder. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | units on a nomogram | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Bladder Outlet Obstruction Index (BOOI) Measured During Pressure-Flow Studies | BOOI, formerly known as the Abrams-Griffith number, was derived from the equation PdetQmax - 2Qmax. Scores: <20 means unobstructed, 20-40 means equivocol, >40 means obstructed. An increase means worsening of obstruction, a decreased means lessening of obstruction (improvement). | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | units on a nomogram | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Presence of Involuntary Detrusor Contractions During Bladder Filling | Number of participants randomized, had started study medication, had both a baseline and an end of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Number | participants | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to 12 Week Endpoint in Bladder Volume at First Involuntary Detrusor Contraction | Assessed in participants with involuntary detrusor contractions during the bladder filling at both baseline and endpoint. | Number of participants in the Primary Analysis Population with involuntary detrusor contractions during bladder filling at both baseline and endpoint. | Posted | Mean | Standard Deviation | milliliters | Baseline and 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 the 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. | Number of participants randomized, had started study medication, had both a baseline and an end-of-study pressure-flow urodynamic assessment, and had at least 37 days (6 weeks minus a 5-day visit window) on treatment between randomization and the final pressure-flow urodynamic assessment. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinically Adverse and Statistically Significant Changes From Baseline to 12 Week Endpoint in Laboratory Tests | Laboratory tests that were statistically significant and clinically adverse would be reported for safety. | All randomized participants. | Posted | Number | significant and clinically adverse labs | Baseline and 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 | placebo tablet taken by mouth once a day for 12 weeks | 2 | 28 | ||||
| EG001 | Tadalafil | 20 mg tadalafil tablet taken by mouth once a day for 12 weeks | 3 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction/Death | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Syncope | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Visual disturbance | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Gastroenteritis aeromonas | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Biopsy prostate | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Diabetes mellitus non-insulin-dependent | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Neoplasm prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nicotine dependence | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urethral pain | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Penis disorder | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peyronie's disease | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Endodontic procedure | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Foot operation | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Tooth repair | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 10.0 | 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 |
| 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 |
Not provided
Not provided
| Male |
|
| Canada |
|
| Severe (IPSS ≥20) |
|
| Missing Baseline Measure |
|
| Equivocal (BOOI 20-40) |
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| Unobstructed (BOOI < 20) |
|
| 1 year to 3 years |
|
| > 3 years |
|
| Moderate |
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| Severe |
|
| No |
|
| No |
|
| No |
|
| Asian |
|
| Black or African American |
|
| Hispanic or Latino |
|
| White |
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