Trial · NCT00855582
A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia
NCT00855582, Phase 3, Completed, Eli Lilly and Company; results first posted 2011-06-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia. Trials, record NCT00855582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00855582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia
- NCT number
- NCT00855582
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 606 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Erectile Dysfunction, Benign Prostatic Hyperplasia
- Interventions
- Tadalafil, Placebo
- First posted
- 2009-03-04
- Last updated
- 2011-07-28
- Results first posted
- 2011-06-30
- Limitations and caveats
- P-values for the peak urine flow rate outcome were corrected in this record after an error was identified.
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg) | Baseline, 12 weeks | 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. |
| Primary | Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg) | Baseline, 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. |
| Primary | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg) | Baseline, 12 weeks | 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. |
| Primary | Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg) | Baseline, 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. |
| Secondary | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg) | Baseline, 12 weeks | 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. |
| Secondary | Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg) | 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. 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. |
| Secondary | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg) | Baseline, 12 weeks | 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. |
| Secondary | Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg) | 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. 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. |
| Secondary | Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint | Baseline, 2 weeks | 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. |
| Secondary | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint | Baseline, 4 weeks, 8 weeks | 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. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg) | Baseline, 12 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg) | Baseline, 12 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg) | Baseline, 12 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg) | Baseline, 12 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg) | Baseline, 12 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value. | percentage of Yes responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Benign Prostatic Hyperplasia (BPH) Impact Index (BII) at Week 12 Endpoint (5 mg) | Baseline, 12 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (2.5 mg) | Baseline, 12 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value. | percentage of yes responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in BPH Impact Index (BII) at Week 12 Endpoint (2.5 mg) | Baseline, 12 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Modified IPSS (mIPSS) at Week 2 Endpoint | Baseline, 2 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in International Prostate Symptom Score (IPSS) at Week 4 and Week 8 Endpoint | Baseline, 4 weeks, 8 weeks | Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF). | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group133
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg) | Tadalafil 5 mg | -6.1 | Standard Error 0.43 | units on a scale | |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (5 mg) | Placebo | -3.8 | Standard Error 0.45 | units on a scale | |
| Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg) | Tadalafil 5 mg | 6.5 | Standard Error 0.49 | units on a scale | |
| Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (5 mg) | Placebo | 1.8 | Standard Error 0.51 | units on a scale | |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg) | Tadalafil 2.5 mg | -4.6 | Standard Error 0.44 | units on a scale | |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 Endpoint (2.5 mg) | Placebo | -3.8 | Standard Error 0.45 | units on a scale | |
| Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg) | Tadalafil 2.5 mg | 5.2 | Standard Error 0.5 | units on a scale | |
| Change From Baseline in International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score at Week 12 Endpoint (2.5 mg) | Placebo | 1.8 | Standard Error 0.51 | units on a scale | |
| Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg) | Tadalafil 5 mg | 31.7 | Standard Error 2.07 | percentage of Yes responses | |
| Change From Baseline in Yes Responses to Sexual Encounter Profile (SEP) Diary Question 3 at Week 12 Endpoint (5 mg) | Placebo | 12.0 | Standard Error 2.14 | percentage of Yes responses |
1 to 10 of 133Source ClinicalTrials.gov
See all 133 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tadalafil 2.5 mg | 198 | |
| Overall Study | STARTED | Tadalafil 5 mg | 208 | |
| Overall Study | STARTED | Placebo | 200 | |
| Overall Study | COMPLETED | Tadalafil 2.5 mg | 172 | |
| Overall Study | COMPLETED | Tadalafil 5 mg | 184 | |
| Overall Study | COMPLETED | Placebo | 170 | |
| Overall Study | NOT COMPLETED | Tadalafil 2.5 mg | 26 | |
| Overall Study | NOT COMPLETED | Tadalafil 5 mg | 24 | |
| Overall Study | NOT COMPLETED | Placebo | 30 |
Source ClinicalTrials.gov
Adverse events384
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 | Anaemia | Blood and lymphatic system disorders | Tadalafil 2.5 mg | 1 | 198 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Tadalafil 5 mg | 0 | 208 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 200 | 0 |
| other | Palpitations | Cardiac disorders | Tadalafil 2.5 mg | 1 | 198 | 1 |
| other | Palpitations | Cardiac disorders | Tadalafil 5 mg | 0 | 208 | 0 |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 200 | 0 |
| other | Cerumen impaction | Ear and labyrinth disorders | Tadalafil 2.5 mg | 0 | 198 | 0 |
| other | Cerumen impaction | Ear and labyrinth disorders | Tadalafil 5 mg | 1 | 208 | 1 |
| other | Cerumen impaction | Ear and labyrinth disorders | Placebo | 0 | 200 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Tadalafil 2.5 mg | 0 | 198 | 0 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tadalafil 2.5 mg | ||
| Total, all-cause mortality | Tadalafil 5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tadalafil 2.5 mg | 50 | 198 |
| Total, other adverse events | Tadalafil 5 mg | 56 | 208 |
| Total, other adverse events | Placebo | 38 | 200 |
| Total, serious adverse events | Tadalafil 2.5 mg | 2 | 198 |
| Total, serious adverse events | Tadalafil 5 mg | 1 | 208 |
| Total, serious adverse events | Placebo | 1 | 200 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00855582
GET https://conductscience.org/api/trials/v1/NCT00855582/registered?page=2