Trial · NCT01937871
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
NCT01937871, Phase 3, Completed, Eli Lilly and Company; results first posted 2017-02-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED). Trials, record NCT01937871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01937871
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
- NCT number
- NCT01937871
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 909 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Benign Prostate Hyperplasia, Erectile Dysfunction
- Interventions
- 5 mg Tadalafil, Placebo, 0.2 mg Tamsulosin
- First posted
- 2013-09-10
- Last updated
- 2017-06-20
- Results first posted
- 2017-02-07
Source ClinicalTrials.gov
Registered outcomes22
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 | Baseline, Week 12 | IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 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 mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10. |
| Secondary | Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 | Baseline, Week 12 | IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction during 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) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10. |
| Secondary | Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 | Baseline, Week 12 | Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q2, "Were you able to insert your penis into your partner's vagina?". The SEP Q2 score was determined as the percentage of "yes" responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of "yes" responses at endpoint minus the percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p \>= 0.10. |
| Secondary | Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12 | Baseline, Week 12 | Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q3, "Did your erection last long enough for you to have successful intercourse?".The SEP Q3 score is determined as the percentage of "yes" responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p \>= 0.10. |
| Secondary | Change From Baseline in IPSS at Week 12 | Baseline, Week 12 | IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 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 mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p \>= 0.10. |
| Secondary | Change From Baseline in Uroflowmetry Measures at Week 12 | Baseline, Week 12 | Qmax is defined as the peak urine flow rate (measured in milliliters per second \[mL/sec\] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included only if the prevoid total bladder volume (assessed by ultrasound) was \>=150 to \<=550 milliliters (mL) and the voided volume (Vcomp) was \>=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group. |
| Secondary | Change From Baseline in Postvoid Residual Volume (PVR) at Week 12 | Baseline, Week 12 | The amount of urine remaining in the bladder after void completion. |
| Secondary | Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12 | Baseline, Week 12 | IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; 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 mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. |
| Secondary | Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12 | Baseline, Week 12 | IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; 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 mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. |
| Secondary | Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12 | Baseline, Week 12 | IPSS QoL assess 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 ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
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 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 | Baseline, Week 12 | All randomized participants who had at least one dose of the study drug, had a baseline and at least one post-baseline IIEF measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. | percentage of yes responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline SEP measurement. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values. | percentage of yes responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IPSS at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Uroflowmetry Measures at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline Uroflowmetry measurement. | Milliliters/seconds (mL/sec) | MEAN |
| SECONDARY | Change From Baseline in Postvoid Residual Volume (PVR) at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline PVR measurement. | milliliters (mL) | MEAN |
| SECONDARY | Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline IPSS measurement. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12 | Baseline, Week 12 | All randomized participants who received at least one dose of the study drug, had a baseline and at least one post-baseline QoL measurement. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group117
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 | Placebo | -4.08 | Standard Error 0.402 | units on a scale | |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | 5 mg Tadalafil | -5.49 | Standard Error 0.395 | units on a scale | |
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 | 0.2 mg Tamsulosin | -4.92 | Standard Error 0.493 | units on a scale | |
| Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 | Placebo | 1.88 | Standard Error 0.448 | units on a scale | |
| Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 | 5 mg Tadalafil | 5.24 | Standard Error 0.439 | units on a scale | |
| Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12 | 0.2 mg Tamsulosin | 2.64 | Standard Error 0.556 | units on a scale | |
| Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 | Placebo | 10.90 | Standard Error 2.618 | percentage of yes responses | |
| Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 | 5 mg Tadalafil | 23.87 | Standard Error 2.548 | percentage of yes responses | |
| Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12 | 0.2 mg Tamsulosin | 6.84 | Standard Error 3.074 | percentage of yes responses | |
| Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12 | Placebo | 15.96 | Standard Error 3.016 | percentage of yes responses |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 361 | |
| Overall Study | STARTED | 5 mg Tadalafil | 363 | |
| Overall Study | STARTED | 0.2 mg Tamsulosin | 185 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo | 361 | |
| Overall Study | Received at Least One Dose of Study Drug | 5 mg Tadalafil | 362 | |
| Overall Study | Received at Least One Dose of Study Drug | 0.2 mg Tamsulosin | 185 | |
| Overall Study | COMPLETED | Placebo | 337 | |
| Overall Study | COMPLETED | 5 mg Tadalafil | 346 | |
| Overall Study | COMPLETED | 0.2 mg Tamsulosin | 174 | |
| Overall Study | NOT COMPLETED | Placebo | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events399
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 | Iron deficiency anaemia | Blood and lymphatic system disorders | Placebo | 1 | 361 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | 5 mg Tadalafil | 0 | 362 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | 0.2 mg Tamsulosin | 0 | 185 | 0 |
| other | Arrhythmia | Cardiac disorders | Placebo | 2 | 361 | 2 |
| other | Arrhythmia | Cardiac disorders | 5 mg Tadalafil | 0 | 362 | 0 |
| other | Arrhythmia | Cardiac disorders | 0.2 mg Tamsulosin | 0 | 185 | 0 |
| other | Arteriosclerosis coronary artery | Cardiac disorders | Placebo | 1 | 361 | 1 |
| other | Arteriosclerosis coronary artery | Cardiac disorders | 5 mg Tadalafil | 0 | 362 | 0 |
| other | Arteriosclerosis coronary artery | Cardiac disorders | 0.2 mg Tamsulosin | 0 | 185 | 0 |
| other | Coronary artery disease | Cardiac disorders | Placebo | 1 | 361 | 1 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 5 mg Tadalafil | ||
| Total, all-cause mortality | 0.2 mg Tamsulosin | ||
| Total, other adverse events | Placebo | 62 | 361 |
| Total, other adverse events | 5 mg Tadalafil | 64 | 362 |
| Total, other adverse events | 0.2 mg Tamsulosin | 21 | 185 |
| Total, serious adverse events | Placebo | 5 | 361 |
| Total, serious adverse events | 5 mg Tadalafil | 7 | 362 |
| Total, serious adverse events | 0.2 mg Tamsulosin | 2 | 185 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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