Benign Prostatic Hyperplasia, Enlarged Prostate
Conditions
Keywords
Benign Prostatic Hyperplasia (BPH), Enlarged Prostate
Brief summary
The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.
Interventions
DRUGTadalafil
5 milligrams (mg) administered orally, once daily for 26 weeks
DRUGPlacebo
Administered orally, once daily for 26 weeks
DRUGFinasteride
5mg administered orally, once daily for 26 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have not taken the following treatments within the indicated duration and agree not to use at any time during the study: * All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication. * Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication. * Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication. * Finasteride or dutasteride use at any time. * Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before receiving study drug. * Have prostate enlargement measured by ultrasound at screening.
Exclusion criteria
* Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer \[Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter (ng/mL) at the start of study\]. * Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention). * Have problems with kidneys, liver, or nervous system * Have uncontrolled diabetes * Have had a stroke or a significant injury to brain or spinal cord. * Have scheduled or planned surgery during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks | Baseline, 12 weeks | The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | Baseline, 4 weeks, 12 weeks, 26 weeks | IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction. |
| Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks | Baseline, 4 weeks, 12 weeks, 26 weeks | IPSS Quality of Life Index assesses participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction. |
| Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks | Baseline, 4 weeks, 12 weeks, 26 weeks | Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction. |
| Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | Baseline, 4 weeks, 12 weeks, 26 weeks | Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction. |
| Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | Baseline, 4 weeks, 12 weeks, 26 weeks | Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction. |
| Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks | Baseline, 4 weeks, 12 weeks, 26 weeks | Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction. |
| Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks | Baseline, 4 weeks, 26 weeks | The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction. |
| Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 26 weeks | Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse). |
| Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks | 26 weeks | The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group. |
| Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 26 weeks | Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse). |
| Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks | Baseline, 26 weeks | Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts. |
| Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Baseline, 4 weeks, 12 weeks, 26 weeks | IIEF Question 3 asks how often a participant 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). IIEF Question 4 asks whether/how often a participant 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 values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction. |
| Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks | Baseline, 4 weeks, 12 weeks, 26 weeks | Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction. |
Countries
Argentina, Belgium, Brazil, Canada, France, Germany, Greece, Italy, Mexico, Poland, Russia, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
The study consisted of 3 periods: a 4-week washout period, a 4-week, single-blind, placebo lead-in period, and a 26-week double-blind randomized active treatment period. Participants who did not complete the washout and placebo lead-in period were considered screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Tadalafil 5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. | 345 |
| Placebo Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks. | 350 |
| Total | 695 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double-Blind Randomized Active Treatment | Adverse Event | 0 | 4 | 10 |
| Double-Blind Randomized Active Treatment | Death | 0 | 1 | 1 |
| Double-Blind Randomized Active Treatment | Entry Criteria Not Met | 0 | 14 | 17 |
| Double-Blind Randomized Active Treatment | Lack of Efficacy | 0 | 3 | 5 |
| Double-Blind Randomized Active Treatment | Lost to Follow-up | 0 | 3 | 4 |
| Double-Blind Randomized Active Treatment | Physician Decision | 0 | 2 | 0 |
| Double-Blind Randomized Active Treatment | Protocol Violation | 0 | 2 | 8 |
| Double-Blind Randomized Active Treatment | Sponsor Decision | 0 | 5 | 6 |
| Double-Blind Randomized Active Treatment | Withdrawal by Subject | 0 | 6 | 13 |
| Washout and Placebo Lead-In Period | Adverse Event | 1 | 0 | 0 |
| Washout and Placebo Lead-In Period | Entry Criteria Not Met | 258 | 0 | 0 |
| Washout and Placebo Lead-In Period | Lost to Follow-up | 10 | 0 | 0 |
| Washout and Placebo Lead-In Period | Physician Decision | 12 | 0 | 0 |
| Washout and Placebo Lead-In Period | Sponsor Decision | 10 | 0 | 0 |
| Washout and Placebo Lead-In Period | Withdrawal by Subject | 83 | 0 | 0 |
Baseline characteristics
| Characteristic | Tadalafil | Total | Placebo |
|---|---|---|---|
| Age Continuous | 63.8 years STANDARD_DEVIATION 7.5 | 63.7 years STANDARD_DEVIATION 7.68 | 63.6 years STANDARD_DEVIATION 7.85 |
| Body Mass Index (BMI) | 28.3 kilograms/square meter (kg/m²) STANDARD_DEVIATION 4 | 28.3 kilograms/square meter (kg/m²) STANDARD_DEVIATION 3.9 | 28.3 kilograms/square meter (kg/m²) STANDARD_DEVIATION 3.8 |
| Erectile Dysfunction No | 118 participants | 245 participants | 127 participants |
| Erectile Dysfunction Yes | 227 participants | 450 participants | 223 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 9 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 80 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 302 Participants | 606 Participants | 304 Participants |
| Height | 173.5 centimeters (cm) STANDARD_DEVIATION 7.9 | 173.7 centimeters (cm) STANDARD_DEVIATION 7.77 | 173.8 centimeters (cm) STANDARD_DEVIATION 7.65 |
| Lower urinary tract symptoms (LUTS) severity Moderate (IPSS<20) | 238 participants | 473 participants | 235 participants |
| Lower urinary tract symptoms (LUTS) severity Severe (IPSS≥20) | 106 participants | 220 participants | 114 participants |
| Lower urinary tract symptoms (LUTS) severity Unknown | 1 participants | 2 participants | 1 participants |
| Peak urine flow rate 10-15 mL/sec | 190 participants | 370 participants | 180 participants |
| Peak urine flow rate <10 milliliters/second (mL/sec) | 154 participants | 323 participants | 169 participants |
| Peak urine flow rate >15 mL/sec | 1 participants | 2 participants | 1 participants |
| Postvoid residual volume (PVR) | 65.5 milliliters (mL) STANDARD_DEVIATION 60.69 | 64.1 milliliters (mL) STANDARD_DEVIATION 60.1 | 62.6 milliliters (mL) STANDARD_DEVIATION 59.57 |
| Prostate Specific Antigen (PSA) | 2.3 nanograms/milliliter (ng/mL) STANDARD_DEVIATION 2.02 | 2.4 nanograms/milliliter (ng/mL) STANDARD_DEVIATION 2.04 | 2.5 nanograms/milliliter (ng/mL) STANDARD_DEVIATION 2.06 |
| Prostate Volume | 48.2 milliliters (mL) STANDARD_DEVIATION 19.43 | 49.4 milliliters (mL) STANDARD_DEVIATION 20.35 | 50.6 milliliters (mL) STANDARD_DEVIATION 21.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 33 Participants | 70 Participants | 37 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 21 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 298 Participants | 594 Participants | 296 Participants |
| Region of Enrollment Argentina | 46 participants | 87 participants | 41 participants |
| Region of Enrollment Belgium | 7 participants | 23 participants | 16 participants |
| Region of Enrollment Brazil | 12 participants | 25 participants | 13 participants |
| Region of Enrollment Canada | 30 participants | 58 participants | 28 participants |
| Region of Enrollment France | 21 participants | 30 participants | 9 participants |
| Region of Enrollment Germany | 24 participants | 52 participants | 28 participants |
| Region of Enrollment Greece | 18 participants | 30 participants | 12 participants |
| Region of Enrollment Italy | 21 participants | 46 participants | 25 participants |
| Region of Enrollment Mexico | 33 participants | 70 participants | 37 participants |
| Region of Enrollment Poland | 32 participants | 71 participants | 39 participants |
| Region of Enrollment Russian Federation | 32 participants | 69 participants | 37 participants |
| Region of Enrollment Turkey | 26 participants | 45 participants | 19 participants |
| Region of Enrollment United States | 43 participants | 89 participants | 46 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 345 Participants | 695 Participants | 350 Participants |
| Sexual activity with female partner No | 40 participants | 84 participants | 44 participants |
| Sexual activity with female partner Not Applicable | 0 participants | 1 participants | 1 participants |
| Sexual activity with female partner Yes | 305 participants | 610 participants | 305 participants |
| Weight | 85.3 kilograms (kg) STANDARD_DEVIATION 14.16 | 85.4 kilograms (kg) STANDARD_DEVIATION 14.15 | 85.6 kilograms (kg) STANDARD_DEVIATION 14.16 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 153 / 1,070 | 105 / 345 | 94 / 350 |
| serious Total, serious adverse events | 1 / 1,070 | 9 / 345 | 5 / 350 |
Outcome results
Primary
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Time frame: Baseline, 12 weeks
Population: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil | Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks | -5.18 units on a scale | Standard Error 0.32 |
| Placebo | Change in Total International Prostate Symptom Score (IPSS) From Baseline to 12 Weeks | -3.76 units on a scale | Standard Error 0.32 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.00195% CI: [-2.27, -0.55]Mixed Model Repeated Measures Analysis
Secondary
Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks
Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Population: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-EF measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | 3.71 units on a scale | Standard Error 0.5 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 4.71 units on a scale | Standard Error 0.56 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | 4.71 units on a scale | Standard Error 0.57 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | -1.14 units on a scale | Standard Error 0.51 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 0.63 units on a scale | Standard Error 0.57 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Erectile Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | -0.02 units on a scale | Standard Error 0.6 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [3.49, 6.21]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [2.55, 5.6]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [3.15, 6.31]Mixed Model Repeated Measures Analysis
Secondary
Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
Self-reported intercourse satisfaction over the past 4 weeks. IIEF-intercourse satisfaction is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Population: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-intercourse satisfaction measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | 1.36 units on a scale | Standard Error 0.24 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 1.68 units on a scale | Standard Error 0.26 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | 1.72 units on a scale | Standard Error 0.27 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | -0.46 units on a scale | Standard Error 0.24 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 0.08 units on a scale | Standard Error 0.27 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Intercourse Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | -0.26 units on a scale | Standard Error 0.28 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [1.18, 2.47]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.88, 2.31]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [1.23, 2.73]Mixed Model Repeated Measures Analysis
Secondary
Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks
Orgasmic Function domain scores is the sum of Questions 9 and 10 from the IIEF questionnaire. Scores range from 0 (low/no orgasm) to 5 (high orgasm) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher total scores indicate higher orgasm. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Population: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-orgasmic function domain score measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | 0.90 units on a scale | Standard Error 0.22 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 1.08 units on a scale | Standard Error 0.23 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | 0.89 units on a scale | Standard Error 0.24 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | -0.63 units on a scale | Standard Error 0.23 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 0.18 units on a scale | Standard Error 0.24 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Orgasmic Function Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | -0.18 units on a scale | Standard Error 0.25 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.92, 2.13]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.00695% CI: [0.27, 1.54]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.00295% CI: [0.41, 1.74]Mixed Model Repeated Measures Analysis
Secondary
Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks
Self-reported overall satisfaction over the past 4 weeks. IIEF-Overall Satisfaction is the sum of Questions 13 and 14 of IIEF questionnaire. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher satisfaction. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Population: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-Overall Satisfaction measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | 0.91 units on a scale | Standard Error 0.15 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 1.38 units on a scale | Standard Error 0.16 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | 1.61 units on a scale | Standard Error 0.17 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | -0.10 units on a scale | Standard Error 0.15 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 0.31 units on a scale | Standard Error 0.17 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Overall Satisfaction Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | 0.40 units on a scale | Standard Error 0.18 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.61, 1.4]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.61, 1.51]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.74, 1.69]Mixed Model Repeated Measures Analysis
Secondary
Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks
IIEF Question 3 asks how often a participant 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). IIEF Question 4 asks whether/how often a participant 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 values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Population: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF Questions 3 and 4 measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 3 - 4 weeks | 0.42 units on a scale | Standard Error 0.09 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 3 - 12 weeks | 0.72 units on a scale | Standard Error 0.09 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 3 - 26 weeks | 0.68 units on a scale | Standard Error 0.1 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 4 - 4 weeks | 0.49 units on a scale | Standard Error 0.09 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 4 - 12 weeks | 0.74 units on a scale | Standard Error 0.09 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 4 - 26 weeks | 0.68 units on a scale | Standard Error 0.1 |
| Placebo | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 4 - 12 weeks | 0.13 units on a scale | Standard Error 0.09 |
| Placebo | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 3 - 4 weeks | -0.32 units on a scale | Standard Error 0.09 |
| Placebo | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 4 - 4 weeks | -0.21 units on a scale | Standard Error 0.09 |
| Placebo | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 3 - 12 weeks | 0.04 units on a scale | Standard Error 0.09 |
| Placebo | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 4 - 26 weeks | 0.06 units on a scale | Standard Error 0.1 |
| Placebo | Change in International Index of Erectile Function (IIEF) Question 3 and 4 Scores From Baseline to 4, 12, and 26 Weeks | Question 3 - 26 weeks | -0.07 units on a scale | Standard Error 0.1 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.49, 0.98]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.43, 0.93]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.48, 1.02]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.46, 0.95]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.36, 0.85]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.35, 0.89]Mixed Model Repeated Measures Analysis
Secondary
Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks
Sexual desire domain scores is the sum of Questions 11 and 12 from the IIEF questionnaire. Scores range from 1 (low/no desire) to 5 (high desire) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher total scores indicate higher desire. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline IIEF, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Population: All randomized participants who were sexually active with female partner and had erectile dysfunction (ED), received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IIEF-sexual desire domain score measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | 0.46 units on a scale | Standard Error 0.12 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | 0.56 units on a scale | Standard Error 0.13 |
| Tadalafil | Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | 0.71 units on a scale | Standard Error 0.13 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks | 4 weeks | -0.47 units on a scale | Standard Error 0.12 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks | 12 weeks | -0.23 units on a scale | Standard Error 0.13 |
| Placebo | Change in International Index of Erectile Function (IIEF) - Sexual Desire Domain Scores From Baseline to 4, 12, and 26 Weeks | 26 weeks | -0.05 units on a scale | Standard Error 0.14 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.61, 1.25]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.44, 1.14]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline IIEF was the covariate. No imputation of missing IIEF data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [0.39, 1.13]Mixed Model Repeated Measures Analysis
Secondary
Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks
IPSS Quality of Life Index assesses participant response to the following question: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response options are Delighted (0); Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Population: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS quality of life measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks | 4 weeks | -0.63 units on a scale | Standard Error 0.07 |
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks | 12 weeks | -0.95 units on a scale | Standard Error 0.07 |
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks | 26 weeks | -1.10 units on a scale | Standard Error 0.08 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks | 4 weeks | -0.32 units on a scale | Standard Error 0.06 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks | 12 weeks | -0.76 units on a scale | Standard Error 0.07 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Quality of Life Index From Baseline to 4, 12, and 26 Weeks | 26 weeks | -0.92 units on a scale | Standard Error 0.08 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [-0.5, -0.14]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.05195% CI: [-0.38, 0]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.10795% CI: [-0.38, 0.04]Mixed Model Repeated Measures Analysis
Secondary
Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks
IPSS storage (irritative) subscore is the sum of Questions 2, 4 and 7 of the 7-component IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore range from 0 to 15. IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score range from 0 to 20. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks
Population: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS subscore measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS storage (irritative) subscore - 4 weeks | -1.27 units on a scale | Standard Error 0.14 |
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS storage (irritative) subscore - 12 weeks | -1.74 units on a scale | Standard Error 0.14 |
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS storage (irritative) subscore - 26 weeks | -2.00 units on a scale | Standard Error 0.15 |
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS voiding (obstructive) subscore - 4 weeks | -2.65 units on a scale | Standard Error 0.19 |
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS voiding (obstructive) subscore - 12 weeks | -3.41 units on a scale | Standard Error 0.21 |
| Tadalafil | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS voiding (obstructive) subscore - 26 weeks | -3.50 units on a scale | Standard Error 0.22 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS voiding (obstructive) subscore - 12 weeks | -2.37 units on a scale | Standard Error 0.21 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS storage (irritative) subscore - 4 weeks | -0.76 units on a scale | Standard Error 0.14 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS voiding (obstructive) subscore - 4 weeks | -1.47 units on a scale | Standard Error 0.19 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS storage (irritative) subscore - 12 weeks | -1.34 units on a scale | Standard Error 0.14 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS voiding (obstructive) subscore - 26 weeks | -2.77 units on a scale | Standard Error 0.22 |
| Placebo | Change in International Prostate Symptom Score (IPSS) Subscores Index From Baseline to 4, 12, and 26 Weeks | IPSS storage (irritative) subscore - 26 weeks | -1.66 units on a scale | Standard Error 0.15 |
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.00795% CI: [-0.87, -0.14]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.0495% CI: [-0.8, -0.02]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.10795% CI: [-0.75, 0.07]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [-1.69, -0.68]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: <0.00195% CI: [-1.62, -0.46]Mixed Model Repeated Measures Analysis
Comparison: MMRM model includes treatment, region, visit, and treatment-by-visit interaction as fixed effects, and subject as a random effect. Baseline total IPSS was the covariate. No imputation of missing total IPSS data was performed. The within-subject errors were modeled using an unstructured covariance structure.p-value: 0.01595% CI: [-1.32, -0.14]Mixed Model Repeated Measures Analysis
Secondary
Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks
Postvoid Residual Volume (PVR) is determined using a portable, calibrated ultrasound device. It consists of the average of a minimum of 3 scans where the residual bladder volume was calculated by averaging the most accurate of the 3 imaging attempts.
Time frame: Baseline, 26 weeks
Population: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline PVR measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil | Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks | -24.8 milliliters (mL) | Standard Deviation 73.08 |
| Placebo | Change in Post Void Residual (PVR) Volume From Baseline to 26 Weeks | -23.1 milliliters (mL) | Standard Deviation 66.15 |
p-value: 0.157Wilcoxon Rank-Sum test
Secondary
Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks
The International Prostate Symptom Score (IPSS) is a rating scale for severity of lower urinary tract symptoms (LUTS). The IPSS has a 7-component questionnaire. Each question is scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes treatment, region, visit, baseline total IPSS, and visit-by-treatment interaction.
Time frame: Baseline, 4 weeks, 26 weeks
Population: All randomized participants who received at least 1 dose of the study drug, had baseline and at least 1 post-baseline IPSS measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks | 4 weeks | -3.95 units on a scale | Standard Error 0.29 |
| Tadalafil | Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks | 26 weeks | -5.51 units on a scale | Standard Error 0.33 |
| Placebo | Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks | 4 weeks | -2.29 units on a scale | Standard Error 0.28 |
| Placebo | Change in Total International Prostate Symptom Score (IPSS) From Baseline to 4 and 26 Weeks | 26 weeks | -4.47 units on a scale | Standard Error 0.33 |
Secondary
Clinician Global Impression of Improvement (CGI-I) at 26 Weeks
Clinician Global Impression of Improvement (CGI-I) measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
Time frame: 26 weeks
Population: All randomized participants who received at least 1 dose of the study drug and had CGI-I measurement at 26 weeks endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 3 = Minimally improved | 98 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 5 = Minimally worse | 5 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 2 = Much improved | 129 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 6 = Much worse | 5 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 4 = No change | 47 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 7 = Very much worse | 0 participants |
| Tadalafil | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 1 = Very much improved | 23 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 7 = Very much worse | 1 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 1 = Very much improved | 22 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 2 = Much improved | 97 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 3 = Minimally improved | 106 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 4 = No change | 48 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 5 = Minimally worse | 10 participants |
| Placebo | Clinician Global Impression of Improvement (CGI-I) at 26 Weeks | 6 = Much worse | 6 participants |
p-value: 0.328Cochran-Mantel-Haenszel
Secondary
Patient Global Impression of Improvement (PGI-I) at 26 Weeks
Patient Global Impression of Improvement (PGI-I) measures the participant's perception of improvement at the time of assessment compared with the start of treatment. Number of participants is reported by the categorized score ranging from 1 (very much better) to 7 (very much worse).
Time frame: 26 weeks
Population: All randomized participants who received at least 1 dose of the study drug and had PGI-I measurement at 26 weeks endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tadalafil | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 3 = Little better | 102 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 5 = A little worse | 10 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 2 = Much better | 124 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 6 = Much worse | 2 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 4 = No change | 49 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 7 = Very much worse | 1 participants |
| Tadalafil | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 1 = Very much better | 21 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 7 = Very much worse | 1 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 1 = Very much better | 29 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 2 = Much better | 82 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 3 = Little better | 112 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 4 = No change | 52 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 5 = A little worse | 5 participants |
| Placebo | Patient Global Impression of Improvement (PGI-I) at 26 Weeks | 6 = Much worse | 7 participants |
p-value: 0.034Cochran-Mantel-Haenszel
Secondary
Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks
The TSS-BPH was a validated participant-rated instrument that measured participant satisfaction with treatment based on a 13-item questionnaire. It consists of 10 items on a Likert-like scale with scores ranging from 1 (higher satisfaction) to 5 (lower satisfaction), 1 item with score ranging from 0 (higher satisfaction) to 5 (lower satisfaction), and 2 yes/no questions. The mean score for each participant ranges from 0.9 (higher satisfaction) to 5.0 (lower satisfaction). Data presented are the average of mean scores for each treatment group.
Time frame: 26 weeks
Population: All randomized participants who received at least 1 dose of the study drug and had TSS-BPH measurement at 26 weeks endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil | Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks | 2.0 units on a scale | Standard Deviation 0.63 |
| Placebo | Treatment Satisfaction Scale - Benign Prostatic Hyperplasia (TSS-BPH) at 26 Weeks | 2.1 units on a scale | Standard Deviation 0.66 |
p-value: 0.031Van Elteren test