Trial · NCT00384930
Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
NCT00384930, Phase 2, Phase 3, Completed, Eli Lilly and Company; results first posted 2009-08-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia. Trials, record NCT00384930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00384930
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Tadalafil Once-a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia
- NCT number
- NCT00384930
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,058 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- tadalafil, tadalafil, tadalafil, tadalafil, placebo
- First posted
- 2006-10-06
- Last updated
- 2009-09-02
- Results first posted
- 2009-08-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis | Baseline and 12 weeks | Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic. |
| Primary | Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis | Baseline and 12 weeks | Assesses the severity of BPH-LUTS and the response to therapy. The total score was derived by summing the scores of the responses to the 7 component questions. Scores range from 0 to 35; 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic. |
| Secondary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | baseline and 12 weeks | Measures irritative symptoms over the past 4 weeks of the IPSS. IPSS irritative subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 1 (few irritative symptoms) to 5 (frequent irritative symptoms), thus the 3 questions of the irritative subscore range from 0 to 15. |
| Secondary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | 12 weeks | Measures obstructive symptoms over the past 4 weeks of the IPSS. IPSS obstructive subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 1 (few obstructive symptoms) to 5 (frequent obstructive symptoms), thus the 4 questions of the obstructive score range from 0 to 20. |
| Secondary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) | baseline and 12 weeks | Measures nocturia (the need to get up at night to urinate) over the past 4 weeks. Scores range from 1 (few episodes of nocturia) to 5 (frequent episodes of nocturia). |
| Secondary | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index | baseline and 12 weeks | Assessment of quality of life (QOL) by urinary symptoms, with scores ranging from 0 (delighted) to 6 (terrible). |
| Secondary | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) | baseline and 12 weeks | Measures the impact that symptoms of BPH has on the patients well being. This questionnaire has 4 questions assessing the level of urinary discomfort and it's impact on the patients. Three questions range from 0 (no impact) to 4 (high impact); one question ranges from 0 (low impact) to 4 (high impact). The BII score ranges from 0 to 16. |
| Secondary | Number of Participants Who Answer "Yes" to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) | 12 weeks | LUTS-GAQ Question asks the participant if the treatment they have been on has improved their uninary symptoms. |
| Secondary | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow | baseline and 12 weeks | Measures the maximum flow rate of urine (measured in mL/s). This is a continuous parameter with positive numeric values. |
| Secondary | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain | baseline and 12 weeks | Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30. |
Source ClinicalTrials.gov
Outcomes10
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 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis | Baseline and 12 weeks | Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | baseline and 12 weeks | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Voiding (Obstructive) Subscore | 12 weeks | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Question 7 (Nocturia) | baseline and 12 weeks | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) Quality of Life (QoL) Index | baseline and 12 weeks | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in Benign Prostatic Hyperplasia Impact Index (BII) | baseline and 12 weeks | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Answer Yes to the Lower Urinary Tract Symptoms (LUTS) Global Assessment Question (LUTS-GAQ) | 12 weeks | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | participants | NUMBER |
| SECONDARY | Change From Baseline to 12 Week Endpoint in Peak Urinary Flow | baseline and 12 weeks | Secondary continuous analyses were performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | milliliter per second | MEAN |
| SECONDARY | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) EF Domain | baseline and 12 weeks | Secondary continuous analyses were performed on an intent-to-treat basis. Data from all randomized and sexually active subjects with a history of ED and non-missing data at baseline and at least one postbaseline visit were used for the analysis. Last observation carried forward. | units on a scale | MEAN |
| PRIMARY | Change From Baseline to Week 12 in International Prostate Symptom Score (IPSS): Supportive Analysis | Baseline and 12 weeks | Primary analysis was performed on an intent-to-treat basis. Data from subjects with baseline and at least one postbaseline were used for the analysis. Last observation carried forward. | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group84
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 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis | Placebo | Baseline | 17.08 | Standard Deviation 6.36 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis | 5 mg Tadalafil | Baseline | 17.30 | Standard Deviation 5.97 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis | Placebo | Change from Baseline | -2.25 | Standard Deviation 6.17 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS): Primary Analysis | 5 mg Tadalafil | Change from Baseline | -4.92 | Standard Deviation 5.67 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | Placebo | Baseline | 7.58 | Standard Deviation 3.09 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | 2.5 mg Tadalafil | Baseline | 7.78 | Standard Deviation 2.86 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | 5 mg Tadalafil | Baseline | 7.65 | Standard Deviation 2.84 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | 10 mg Tadalafil | Baseline | 7.88 | Standard Deviation 2.67 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | 20 mg Tadalafil | Baseline | 7.53 | Standard Deviation 3.07 | units on a scale |
| Change From Baseline to 12 Week Endpoint in International Prostate Symptom Score (IPSS) (Irritative) Subscore | Placebo | Change from Baseline | -0.99 | Standard Deviation 2.92 | units on a scale |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 212 | |
| Overall Study | STARTED | 2.5 mg Tadalafil | 209 | |
| Overall Study | STARTED | 5 mg Tadalafil | 212 | |
| Overall Study | STARTED | 10 mg Tadalafil | 216 | |
| Overall Study | STARTED | 20 mg Tadalafil | 209 | |
| Overall Study | Received Double-Blind Study Drug | Placebo | 211 | |
| Overall Study | Received Double-Blind Study Drug | 2.5 mg Tadalafil | 208 | |
| Overall Study | Received Double-Blind Study Drug | 5 mg Tadalafil | 212 | |
| Overall Study | Received Double-Blind Study Drug | 10 mg Tadalafil | 216 | |
| Overall Study | Received Double-Blind Study Drug | 20 mg Tadalafil | 209 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,075
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 | Arrhythmia | Cardiac disorders | Placebo | 0 | 212 | 0 |
| other | Arrhythmia | Cardiac disorders | 2.5 mg Tadalafil | 1 | 209 | 1 |
| other | Arrhythmia | Cardiac disorders | 5 mg Tadalafil | 0 | 212 | 0 |
| other | Arrhythmia | Cardiac disorders | 10 mg Tadalafil | 0 | 216 | 0 |
| other | Arrhythmia | Cardiac disorders | 20 mg Tadalafil | 0 | 209 | 0 |
| other | Atrioventricular block second degree | Cardiac disorders | Placebo | 0 | 212 | 0 |
| other | Atrioventricular block second degree | Cardiac disorders | 2.5 mg Tadalafil | 0 | 209 | 0 |
| other | Atrioventricular block second degree | Cardiac disorders | 5 mg Tadalafil | 0 | 212 | 0 |
| other | Atrioventricular block second degree | Cardiac disorders | 10 mg Tadalafil | 0 | 216 | 0 |
| other | Atrioventricular block second degree | Cardiac disorders | 20 mg Tadalafil | 1 | 209 | 1 |
1 to 10 of 1,075Source ClinicalTrials.gov
See all 1,075 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 2.5 mg Tadalafil | ||
| Total, all-cause mortality | 5 mg Tadalafil | ||
| Total, all-cause mortality | 10 mg Tadalafil | ||
| Total, all-cause mortality | 20 mg Tadalafil | ||
| Total, other adverse events | Placebo | 43 | |
| Total, other adverse events | 2.5 mg Tadalafil | 54 | |
| Total, other adverse events | 5 mg Tadalafil | 65 | |
| Total, other adverse events | 10 mg Tadalafil | 75 | |
| Total, other adverse events | 20 mg Tadalafil | 80 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers4
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/NCT00384930
GET https://conductscience.org/api/trials/v1/NCT00384930/results?page=2