Trial · NCT02431754
A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).
NCT02431754, Phase 4, Completed, Eli Lilly and Company; results first posted 2017-03-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS). Trials, record NCT02431754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02431754
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tadalafil (LY450190) in Participants With Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia LUTS (BPH-LUTS).
- NCT number
- NCT02431754
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 171 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Tadalafil, Placebo, Alpha1 Blocker
- First posted
- 2015-05-01
- Last updated
- 2017-07-02
- Results first posted
- 2017-03-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ) | Week 20 | TPQ was used to investigate participant's preference between alpha1 blocker monotherapy and combination therapy with alpha1 blocker plus tadalafil. At the end of Treatment Period 2 (or discontinuation), participants were asked to choose a preferred treatment between the two treatments given in Treatment Period 1 and Treatment Period 2. |
| Secondary | Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score | Baseline, Week 8 | 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. |
| Secondary | Change From Baseline on the IPSS Storage (Irritative) Subscore | Baseline,Week 8 | IPSS Storage (Irritative) subscore was 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. |
| Secondary | Change From Baseline on the IPSS Voiding (Obstructive) Subscore | Baseline, Week 8 | 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. |
| Secondary | Change From Baseline on the IPSS Quality of Life Score (IPSS QoL ) | Baseline, Week 8 | 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 with higher numerical score representing worse Quality of Life from BPH symptom. |
| Secondary | Percentage of Participants With Global Impression of Improvement (PGI-I) | Week 8 | The PGI I is a participant rated instrument that measures the improvement or worsening of the subject's symptoms based on a 7 point scale. A score of "1" indicates that the subject feels his symptoms are "very much better." A score of "4" indicates that the subjects feels "no change" in his symptoms and a score of "7" indicates that the subject feels his symptoms are "very much worse." The percentage of participants who reported a PGI-I score of 1 to 3 are presented in the table below. |
| Secondary | Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement | Week 8 | PGI-I (Drug Attributes Questionnaire \[DRAQ\]) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms.The DRAQ includes the following urinary symptoms: 1. Difficulty to void; 2. Frequent nighttime voiding; 3. Feeling of incomplete emptying; 4. Frequent daytime voiding; 5. Urinary urgency; 6. Taking a long time to urinate; 7. Need abdominal pressure to void; 8. Dribbling, leakage, and/or accidents. Each urinary symptom in the DRAQ will be evaluated by a participant using the PGI-I (discrete variables with seven categories) at the end of each treatment period, compared with how the symptom was before the participant's began taking medication in this study. The percentage of participants who reported a PGI-I (Drug Attributes Questionnaire) score of 1 to 3 are presented in the table below. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ) | Week 20 | All randomized participants who received at least one dose of study drug and completed the TPQ. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score | Baseline, Week 8 | All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline on the IPSS Storage (Irritative) Subscore | Baseline,Week 8 | All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline on the IPSS Voiding (Obstructive) Subscore | Baseline, Week 8 | All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement. | units on a scale | MEAN |
| SECONDARY | Change From Baseline on the IPSS Quality of Life Score (IPSS QoL ) | Baseline, Week 8 | All randomized participants who received at least one dose of study drug and had a baseline and post baseline IPSS measurement. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Global Impression of Improvement (PGI-I) | Week 8 | All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I measurement. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PGI-I (Drug Attributes Questionnaire) on 8 Symptoms for BPH-Lower Urinary Tract Symptoms Improvement | Week 8 | All randomized participants who received at least one dose of study drug and had a baseline and post baseline PGI-I (DRAQ) measurement. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ) | Tadalafil/Placebo | Prefer therapy tadalafil + a1 blocker | 44.0 | percentage of participants | |
| Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ) | Placebo/Tadalafil | Prefer therapy tadalafil + a1 blocker | 68.3 | percentage of participants | |
| Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ) | Tadalafil/Placebo | Prefer therapy placebo + a1 blocker | 56.0 | percentage of participants | |
| Percentage of Participants Preferring Combination Therapy Over Alpha Blocker Alone on the Treatment Preference Questionnaire (TPQ) | Placebo/Tadalafil | Prefer therapy placebo + a1 blocker | 31.7 | percentage of participants | |
| Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score | Tadalafil | -2.5 | Standard Deviation 5.1 | units on a scale | |
| Change From Baseline on the International Prostate Symptom Score (IPSS) Total Score | Placebo | -1.8 | Standard Deviation 4.2 | units on a scale | |
| Change From Baseline on the IPSS Storage (Irritative) Subscore | Tadalafil | -0.6 | Standard Deviation 2.1 | units on a scale | |
| Change From Baseline on the IPSS Storage (Irritative) Subscore | Placebo | -0.5 | Standard Deviation 1.9 | units on a scale | |
| Change From Baseline on the IPSS Voiding (Obstructive) Subscore | Tadalafil | -2.0 | Standard Deviation 3.6 | units on a scale | |
| Change From Baseline on the IPSS Voiding (Obstructive) Subscore | Placebo | -1.3 | Standard Deviation 3.0 | units on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (8 Weeks) | STARTED | Tadalafil/Placebo | 85 | |
| Period 1 (8 Weeks) | STARTED | Placebo/Tadalafil | 86 | |
| Period 1 (8 Weeks) | Received at Least One Dose of Study Drug | Tadalafil/Placebo | 85 | |
| Period 1 (8 Weeks) | Received at Least One Dose of Study Drug | Placebo/Tadalafil | 86 | |
| Period 1 (8 Weeks) | COMPLETED | Tadalafil/Placebo | 79 | |
| Period 1 (8 Weeks) | COMPLETED | Placebo/Tadalafil | 82 | |
| Period 1 (8 Weeks) | NOT COMPLETED | Tadalafil/Placebo | 6 | |
| Period 1 (8 Weeks) | NOT COMPLETED | Placebo/Tadalafil | 4 | |
| Wash-out Period (4 Weeks) | STARTED | Tadalafil/Placebo | 79 | |
| Wash-out Period (4 Weeks) | STARTED | Placebo/Tadalafil | 82 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse 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 | Anaemia | Blood and lymphatic system disorders | Tadalafil | 0 | 167 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 161 | 1 |
| other | Palpitations | Cardiac disorders | Tadalafil | 1 | 167 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 161 | 0 |
| other | Ear discomfort | Ear and labyrinth disorders | Tadalafil | 0 | 167 | 0 |
| other | Ear discomfort | Ear and labyrinth disorders | Placebo | 1 | 161 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Tadalafil | 3 | 167 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 0 | 161 | 0 |
| other | Conjunctival haemorrhage | Eye disorders | Tadalafil | 1 | 167 | 1 |
| other | Conjunctival haemorrhage | Eye disorders | Placebo | 0 | 161 | 0 |
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 | 47 | 167 |
| Total, other adverse events | Placebo | 39 | 161 |
| Total, serious adverse events | Tadalafil | 0 | 167 |
| Total, serious adverse events | Placebo | 0 | 161 |
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 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.
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