Trial · NCT00827242
Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily
NCT00827242, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-11-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily. Trials, record NCT00827242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00827242
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily
- NCT number
- NCT00827242
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 325 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Placebo, tadalafil
- First posted
- 2009-01-22
- Last updated
- 2010-11-17
- Results first posted
- 2010-11-17
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) | Baseline, 12 weeks | The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 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, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction. |
| Secondary | Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index | Baseline, 4 weeks | The BPH Impact Index (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. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction. |
| Secondary | Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index | Baseline, 12 weeks | 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. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction. |
| Secondary | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Baseline, 12 weeks | IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction. |
| Secondary | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | Baseline, 12 weeks | IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction. |
| Secondary | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question | Baseline, 12 weeks | Measures nocturia (the need to get up at night to urinate). Scores range from 0 (few episodes of nocturia) to 5 (frequent episodes of nocturia). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction. |
| Secondary | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index | Baseline, 12 weeks | Assessment of QoL by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction. |
| Secondary | Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories | 12 weeks | A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). |
| Secondary | Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories | 12 weeks | Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). |
| Secondary | Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS) | Baseline, 1 week | The IPSS Total Score is obtained by combining the scores of the responses to Question 1 through Question 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. LS mean of change from baseline to endpoint is from an ANCOVA. The model includes terms for treatment group, region, centered-baseline covariate, centered-baseline-by-treatment interaction and treatment-by-region interaction. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) | Baseline, 12 weeks | The analysis population was defined as all subjects who were randomized, started study medication, and had non-missing data at baseline and at least one post-baseline visit. The Last Observation Carried Forward (LOCF) imputation technique was employed. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index | Baseline, 4 weeks | The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 4. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index | Baseline, 12 weeks | The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 12. For the 12 week analysis, the LOCF imputation technique was used. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Baseline, 12 weeks | The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | Baseline, 12 weeks | The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Nocturia Question | Baseline, 12 weeks | The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index | Baseline, 12 weeks | The analysis population was defined as all randomized subjects who started study medication, and had non-missing data at baseline and at least one post-baseline measurement. The LOCF imputation technique was employed. | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Patient Global Impression of Improvement (PGI-I), Number of Participants in 7 Response Categories | 12 weeks | The analysis population includes all subjects who were randomized, started study medication, and had non-missing data. | Participants | NUMBER |
| SECONDARY | Clinical Global Impression of Improvement (CGI-I), Number of Participants in 7 Response Categories | 12 weeks | All values are based on the number of subjects in the analysis population with non-missing data. | Participants | NUMBER |
| SECONDARY | Change From Baseline to 1 Week, International Prostate Symptom Score (IPSS) | Baseline, 1 week | The analysis population includes all subjects who were randomized, started study medication, and had non-missing data at baseline and Week 1. | Units on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) | Tadalafil | -5.6 | Standard Error 0.47 | Units on a Scale | |
| Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) | Placebo | -3.6 | Standard Error 0.47 | Units on a Scale | |
| Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index | Tadalafil | -1.8 | Standard Error 0.18 | Units on a Scale | |
| Change From Baseline to 4 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index | Placebo | -1.2 | Standard Error 0.18 | Units on a Scale | |
| Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index | Tadalafil | -1.8 | Standard Error 0.21 | Units on a Scale | |
| Change From Baseline to 12 Weeks, Benign Prostatic Hyperplasia (BPH) Impact Index | Placebo | -1.3 | Standard Error 0.21 | Units on a Scale | |
| Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Tadalafil | -2.3 | Standard Error 0.22 | Units on a Scale | |
| Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Storage (Irritative) Subscore | Placebo | -1.3 | Standard Error 0.21 | Units on a Scale | |
| Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | Tadalafil | -3.3 | Standard Error 0.31 | Units on a Scale | |
| Change From Baseline to 12 Weeks, International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | Placebo | -2.3 | Standard Error 0.31 | Units on a Scale |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tadalafil | 161 | |
| Overall Study | STARTED | Placebo | 164 | |
| Overall Study | COMPLETED | Tadalafil | 148 | |
| Overall Study | COMPLETED | Placebo | 152 | |
| Overall Study | NOT COMPLETED | Tadalafil | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events124
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrioventricular block first degree | Cardiac disorders | Tadalafil | 0 | 161 | 0 |
| other | Atrioventricular block first degree | Cardiac disorders | Placebo | 1 | 164 | 1 |
| other | Bundle branch block right | Cardiac disorders | Tadalafil | 0 | 161 | 0 |
| other | Bundle branch block right | Cardiac disorders | Placebo | 1 | 164 | 1 |
| other | Deafness | Ear and labyrinth disorders | Tadalafil | 1 | 161 | 1 |
| other | Deafness | Ear and labyrinth disorders | Placebo | 0 | 164 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Tadalafil | 1 | 161 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 0 | 164 | 0 |
| other | Hypothyroidism | Endocrine disorders | Tadalafil | 1 | 161 | 1 |
| other | Hypothyroidism | Endocrine disorders | Placebo | 1 | 164 | 1 |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tadalafil | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tadalafil | 41 | 161 |
| Total, other adverse events | Placebo | 36 | 164 |
| Total, serious adverse events | Tadalafil | 2 | 161 |
| Total, serious adverse events | Placebo | 0 | 164 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tadalafil vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00827242
GET https://conductscience.org/api/trials/v1/NCT00827242/results?page=2