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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-MC-LVHR | Other Identifier | Eli Lilly and Company |
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Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil 2.5 mg | Experimental |
| |
| Tadalafil 5 mg | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | tablet once daily by mouth for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg) | The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg) | Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg) | The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg) | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. |
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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. | Anchorage | Alaska | 99508 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26299520 | Derived | Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24. | |
| 24119319 |
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There is a 4-week washout during Screening in order to assess symptoms and uroflowmetry data in the absence of therapy. After the screening/washout period, subjects began a 4-week single-blind, placebo lead-in period to assess treatment and study procedure compliance and to establish baseline levels.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tadalafil 2.5 mg | 2.5 mg tablet once daily by mouth for 12 weeks. |
| FG001 | Tadalafil 5 mg | 5 mg tablet once daily by mouth for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Matching 2.5 or 5 mg placebo tablet once daily by mouth for 12 weeks. |
|
Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. |
| Baseline, 12 weeks |
| Baseline, 12 weeks |
| Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg) | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg) | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg) | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint | The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 2 weeks |
| Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint | The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 4 weeks, 8 weeks |
| Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint | Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 4 weeks, 8 weeks |
| Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 4 weeks, 8 weeks |
| Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 4 weeks, 8 weeks |
| Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint | IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint | IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12 | The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint | Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint | Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint | Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint | IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint | IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5 | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Baseline, 12 weeks |
| Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint | A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). | 12 weeks |
| Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint | A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). | 12 weeks |
| Erectile Function General Assessment Questionnaire (EF-GAQ) | The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response. | 12 weeks |
| Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint | Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL. | Baseline, 12 weeks |
| Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint | Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL. | Baseline, 12 weeks |
| Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint | Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL. | Baseline, 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. | Phoenix | Arizona | 85050 | 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. | La Mesa | California | 91942 | 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. | Los Angeles | California | 90017 | 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. | Newport Beach | California | 92660 | 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 Diego | California | 92120 | 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. | Englewood | Colorado | 80113 | 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. | Urbana | Illinois | 61801 | 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. | West Des Moines | Iowa | 50266 | 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. | Minneapolis | Minnesota | 55455 | 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. | Missoula | Montana | 59802 | 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. | Edmond | Oklahoma | 73034 | 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. | Dallas | Texas | 75231 | 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. | Mountlake Terrace | Washington | 98043 | 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. | Spokane | Washington | 99202 | United States |
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| 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. | Milan | 20132 | Italy |
| 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. | Sassari | 07100 | Italy |
| 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. | Trieste | 31149 | Italy |
| 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. | Colima | 28000 | Mexico |
| 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. | Durango | 34000 | Mexico |
| 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. | La Joya | 14000 | Mexico |
| 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. | Mexico City | 14050 | Mexico |
| 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. | Morelia | 58000 | Mexico |
| 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. | Amadora | 2700-351 | 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. | Coimbra | 3000-075 | 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 | 1250-203 | 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 | 4202-451 | 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. | Moscow | 119435 | Russia |
| 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. | Rostov-on-Don | 344011 | Russia |
| Derived |
| Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2. |
| FG002 | Placebo | Matching placebo tablet once daily by mouth for 12 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tadalafil 2.5 mg | 2.5 mg tablet once daily by mouth for 12 weeks. |
| BG001 | Tadalafil 5 mg | 5 mg tablet once daily by mouth for 12 weeks. |
| BG002 | Placebo | Matching placebo tablet once daily by mouth for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Body mass index is an estimate of body fat based on body weight divided by height squared. | Mean | Standard Deviation | kg/m² |
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| Lower Urinary Tract Symptoms (LUTS) Severity | The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. | Number | participants |
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| Peak Urine Flow Rate (Qmax) | Number | participants |
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| Postvoid Residual Volume (PRV) | Mean | Standard Deviation | mL |
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| Erectile Dysfunction (ED) - Etiology | Number | participants |
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| ED - Severity | Self-reported erectile function over the past 4 weeks. 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; lower numerical scores represent greater severity of erectile dysfunction. | Number | participants |
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| ED - Duration | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg) | The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Primary | Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg) | Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Primary | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg) | The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Primary | Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg) | Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg) | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of Yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Least Squares Mean | Standard Error | percentage of Yes responses | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg) | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg) | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Least Squares Mean | Standard Error | percentage of yes responses | Baseline, 12 weeks |
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| Secondary | Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg) | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint | The Modified IPSS is the total IPSS collected at 2 weeks post-baseline. The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 2 weeks |
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| Secondary | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint | The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4 weeks, 8 weeks |
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| Secondary | Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain at Week 4 and Week 8 Endpoint | Self-reported erectile function over the past 4 weeks. Questions 1-5 were scored from 0-5, and Question 15 from 1 to 5. Erectile Function Domain scores range from 1 to 30; lower numerical scores represent greater severity of erectile dysfunction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4 weeks, 8 weeks |
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| Secondary | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 4 and Week 8 Endpoint | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3, "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Least Squares Mean | Standard Error | percentage of yes responses | Baseline, 4 weeks, 8 weeks |
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| Secondary | Change From Baseline in BPH Impact Index (BII) at Week 4 and 8 Endpoint | The BII is a 4-item, self-administered questionnaire evaluating impact of urinary problems on overall health and activity. Total scores range from 0 to 13; higher scores represent increased perceived impact of benign prostatic hyperplasia-lower urinary tract symptoms on overall health. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 4 weeks, 8 weeks |
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| Secondary | Change From Baseline in International Prostate Symptom Score Voiding (Obstructive) Subscore at Week 12 Endpoint | IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. The obstructive subscore ranges from 0 to 20 with a higher score representing greater obstruction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in International Prostate Symptom Score Storage (Irritative) Subscore at Week 12 Endpoint | IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. The irritative subscore ranges from 0 to 15 with a higher score representing more irritative symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in International Prostate Symptom Score Nocturia Question at Week 12 | The IPSS Nocturia question (Question 7) measures the number of times needed to get up at night to urinate. Scores range from 0 (none) to 5 (5 or more times). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in International Prostate Symptom Score Quality of Life (QoL) at Week 12 Endpoint | Assessment of quality of life (QoL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in International Index of Erectile Function - Overall Satisfaction Domain at Week 12 Endpoint | Self-reported overall satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 13 and 14. Each question is scored from 1 through 5, with a possible total score of 2 through 10. Higher scores represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in International Index of Erectile Function - Intercourse Satisfaction Domain at Week 12 Endpoint | Self-reported intercourse satisfaction over the past 4 weeks. Calculated as the sum of IIEF Questions 6, 7 and 8. Each question is scored from 0 through 5 with a possible total score of 0 through 15. Higher score represent greater satisfaction. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Deviation | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in International Index of Erectile Function Question 3 at Week 12 Endpoint | IIEF Question 3 asks how often a subject was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in International Index of Erectile Function Question 4 at Week 12 Endpoint | IIEF Question 4 asks whether how often a subject was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 2 at Week 12 Endpoint | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2, "Were you able to insert your penis into your partner's vagina?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Least Squares Mean | Standard Error | percentage of yes responses | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 4 at Week 12 Endpoint | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4, "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Least Squares Mean | Standard Error | percentage of yes responses | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 5 | Assessed as the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5, "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of yes responses per the number of sexual attempts for a participant during a study period. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment group, region, baseline covariate, baseline-by-treatment interaction and treatment-by-region interaction. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Least Squares Mean | Standard Error | percentage of yes responses | Baseline, 12 weeks |
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| Secondary | Patient Global Impression of Improvement (PGI-I) at Week 12 Endpoint | A scale that measures the patient's perception of urinary symptoms at endpoint compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). | Participants started study medication, and had non-missing data. | Posted | Number | participants | 12 weeks |
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| Secondary | Clinician Global Impression of Improvement (CGI-I) at Week 12 Endpoint | A scale that measures clinician's rating of the total change in the patient's urinary symptoms at endpoint compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).The data are presented as the number of participants in each of the seven categories: very much better (1); much better (2); a little better (3); no change (4); a little worse (5); much worse (6); very much worse (7). | Participants started study medication, and had non-missing data. | Posted | Number | participants | 12 weeks |
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| Secondary | Erectile Function General Assessment Questionnaire (EF-GAQ) | The EF-GAQ consisted of two questions: (1) Has the treatment you have been taking during this study improved your erections? and (2) If yes, has the treatment improved your ability to engage in sexual activity? Each question has a Yes/No response. | Participants started study medication, and had non-missing data. | Posted | Number | participants with yes response | 12 weeks |
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| Secondary | Change From Baseline in Uroflowmetry Parameters - Peak Urine Flow Rate (Qmax) at Week 12 Endpoint | Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Mean | Standard Deviation | mL/sec | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Uroflowmetry Parameters - Mean Urine Flow Rate (Qmean) at Week 12 Endpoint | Qmean is defined as the average urine flow rate (measured in milliliters per second [mL/second] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Mean | Standard Deviation | mL/sec | Baseline, 12 weeks |
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| Secondary | Change From Baseline in Uroflowmetry Parameters - Voided Volume (Vcomp) at Week 12 Endpoint | Vcomp is defined as the volume of urine voided (measures in mL using a standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included in the statistical analyses only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >= 125 mL. | Participants with non-missing baseline value and at least one non-missing post baseline value. | Posted | Mean | Standard Deviation | mL | Baseline, 12 weeks |
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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 | Tadalafil 2.5 mg | 2.5 mg tablet once daily by mouth for 12 weeks. | 2 | 198 | 50 | 198 | ||
| EG001 | Tadalafil 5 mg | 5 mg tablet once daily by mouth for 12 weeks. | 1 | 208 | 56 | 208 | ||
| EG002 | Placebo | Matching placebo tablet once daily by mouth for 12 weeks. | 1 | 200 | 38 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA13.0 | Systematic Assessment | This event resulted in death. |
|
| Pancreatitis haemorrhagic | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA13.0 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA13.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA13.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA13.0 | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA13.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA13.0 | Systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA13.0 | Systematic Assessment |
| |
| Photopsia | Eye disorders | MedDRA13.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA13.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA13.0 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA13.0 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA13.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA13.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA13.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA13.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA13.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA13.0 | Systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Infected bites | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA13.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA13.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA13.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA13.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA13.0 | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA13.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA13.0 | Systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Blood testosterone decreased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Scan myocardial perfusion abnormal | Investigations | MedDRA13.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA13.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA13.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Drooling | Nervous system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA13.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA13.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA13.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA13.0 | Systematic Assessment |
| |
| Post-traumatic stress disorder | Psychiatric disorders | MedDRA13.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA13.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA13.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA13.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA13.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA13.0 | Systematic Assessment |
| |
| Terminal dribbling | Renal and urinary disorders | MedDRA13.0 | Systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDRA13.0 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA13.0 | Systematic Assessment |
| |
| Priapism | Reproductive system and breast disorders | MedDRA13.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA13.0 | Systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA13.0 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA13.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA13.0 | Systematic Assessment |
| |
| Intervertebral disc operation | Surgical and medical procedures | MedDRA13.0 | Systematic Assessment |
| |
| Nasal septal operation | Surgical and medical procedures | MedDRA13.0 | Systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA13.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA13.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA13.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA13.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA13.0 | Systematic Assessment |
|
P-values for the peak urine flow rate outcome were corrected in this record after an error was identified.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Office | Eli Lilly and Company | 800-545-5979 |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D011469 | Prostatic 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 |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Portugal |
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| United States |
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| Mexico |
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| Canada |
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| Greece |
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| Russian Federation |
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| Germany |
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| Italy |
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| Severe (IPSS ≥20) |
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| Unknown |
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| 10-15 mL/sec |
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| >15mL/sec |
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| Unknown |
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| Organic |
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| Mixed |
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| Unknown |
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| Moderate (IIEF EF Domain 11-16) |
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| Severe (IIEF EF Domain 1-10) |
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| ≥1 year |
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