Trial · NCT01152190
A Study in Benign Prostatic Hyperplasia
NCT01152190, Phase 3, Completed, Eli Lilly and Company; results first posted 2013-05-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Benign Prostatic Hyperplasia. Trials, record NCT01152190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01152190
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Benign Prostatic Hyperplasia
- NCT number
- NCT01152190
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 97 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Tadalafil, Placebo
- First posted
- 2010-06-29
- Last updated
- 2013-05-20
- Results first posted
- 2013-05-20
- Limitations and caveats
- The primary and secondary efficacy analyses of resistive index (RI) and color pixel intensity (CPI) were based on centrally-read data.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone | Baseline, Week 8 | Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to blood flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix. |
| Secondary | Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone | Baseline, Week 4 | Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix. |
| Secondary | Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck | Baseline, Week 4 and Week 8 | Arterial RI was a measure of vascular resistance using Doppler ultrasound. RI was the ratio of (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and increased as resistance to flow increased. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix. |
| Secondary | Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck | Baseline, Week 4 and Week 8 | CPI quantified blood flow in a pre-specified region of interest by using color Doppler imaging. CPI was the mean color pixel intensity in the region of interest and scores could range from 0 to 160. An increase in CPI reflected an increase in blood flow. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included fixed effects for treatment, region, visit, and treatment-by-visit interaction, baseline as a covariate, a random effect of participant within treatment, and an unstructured covariance matrix. |
Source ClinicalTrials.gov
Outcomes4
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 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone | Baseline, Week 8 | Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone | Baseline, Week 4 | Randomized participants who received at least 1 dose of study medication, had non-missing data (arterial RI in the prostate transition zone) at baseline, and a post-baseline visit. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck | Baseline, Week 4 and Week 8 | Randomized participants who received at least 1 dose of study medication. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4 and 8 Weeks in Color Pixel Intensity (CPI) in the Prostate Transition Zone, Peripheral Zone, and Bladder Neck | Baseline, Week 4 and Week 8 | Randomized participants who received at least 1 dose of study medication. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group24
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 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone | Placebo | -0.01 | Standard Error 0.006 | ratio | |
| Change From Baseline to 8-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone | Tadalafil | 0.00 | Standard Error 0.006 | ratio | |
| Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone | Placebo | 0.00 | Standard Error 0.006 | ratio | |
| Change From Baseline to 4-Week Endpoint in Arterial Resistive Index (RI) in the Prostate Transition Zone | Tadalafil | 0.01 | Standard Error 0.006 | ratio | |
| Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck | Placebo | Week 4 Change, Prostate Peripheral Zone (n=45, 43) | 0.00 | Standard Error 0.006 | ratio |
| Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck | Tadalafil | Week 4 Change, Prostate Peripheral Zone (n=45, 43) | 0.01 | Standard Error 0.007 | ratio |
| Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck | Placebo | Week 8 Change, Prostate Peripheral Zone (n=43, 38) | -0.01 | Standard Error 0.006 | ratio |
| Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck | Tadalafil | Week 8 Change, Prostate Peripheral Zone (n=43, 38) | 0.01 | Standard Error 0.007 | ratio |
| Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck | Placebo | Week 4 Change, Bladder Neck (n=30, 30) | -0.01 | Standard Error 0.012 | ratio |
| Change From Baseline to 4 and 8 Weeks in Arterial Resistive Index (RI) in the Prostate Peripheral Zone and Bladder Neck | Tadalafil | Week 4 Change, Bladder Neck (n=30, 30) | 0.01 | Standard Error 0.012 | ratio |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 50 | |
| Overall Study | STARTED | Tadalafil | 47 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 50 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tadalafil | 47 | |
| Overall Study | COMPLETED | Placebo | 45 | |
| Overall Study | COMPLETED | Tadalafil | 39 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Tadalafil | 8 |
Source ClinicalTrials.gov
Adverse events46
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 | Abdominal pain upper | Gastrointestinal disorders | Placebo | 0 | 50 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Tadalafil | 1 | 47 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 50 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Tadalafil | 1 | 47 | 1 |
| other | Gastric disorder | Gastrointestinal disorders | Placebo | 0 | 50 | 0 |
| other | Gastric disorder | Gastrointestinal disorders | Tadalafil | 1 | 47 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 1 | 50 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Tadalafil | 0 | 47 | 0 |
| other | Bronchitis | Infections and infestations | Placebo | 0 | 50 | 0 |
| other | Bronchitis | Infections and infestations | Tadalafil | 1 | 47 | 1 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Tadalafil | ||
| Total, other adverse events | Placebo | 4 | 50 |
| Total, other adverse events | Tadalafil | 10 | 47 |
| Total, serious adverse events | Placebo | 2 | 50 |
| Total, serious adverse events | Tadalafil | 0 | 47 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24938580 | DERIVED |
Source PubMed
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/NCT01152190
GET https://conductscience.org/api/trials/v1/NCT01152190/results?page=2