Trial · NCT01026818
A Study of Tadalafil After Radical Prostatectomy
NCT01026818, Phase 4, Completed, Eli Lilly and Company; results first posted 2013-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tadalafil After Radical Prostatectomy. Trials, record NCT01026818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01026818
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tadalafil After Radical Prostatectomy
- NCT number
- NCT01026818
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 583 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Erectile Dysfunction
- Interventions
- Tadalafil, Placebo
- First posted
- 2009-12-04
- Last updated
- 2014-01-14
- Results first posted
- 2013-11-14
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire | Month 10.5 | Self-reported erectile function 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 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22. |
| Secondary | Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain | Month 9 and Month 13.5 | Self-reported erectile function 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 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22. |
| Secondary | Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score | Randomization (Baseline), Months 9 and 10.5 and 13.5 | Self-reported erectile function 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 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10). |
| Secondary | Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain) | Randomization (Baseline), Months 9 and 10.5 and 13.5 | Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10). |
| Secondary | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score | Months 9 and 13.5 | The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10). |
| Secondary | Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score | Randomization (Baseline), Months 9 and 13.5 | The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\<0.10). |
| Secondary | Global Assessment Questions (GAQ) Question 1 at Month 9 | Month 9 | GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7). |
| Secondary | Global Assessment Question (GAQ) Question 1 at Month 13.5 | Month 13.5 | GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7). |
| Secondary | Global Assessment Question (GAQ) Question 2 at Month 9 | Month 9 | GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7). |
| Secondary | Global Assessment Question (GAQ) Question 2 at Month 13.5 | Month 13.5 | GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7). |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire | Month 10.5 | All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurement at Month 10.5. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain | Month 9 and Month 13.5 | All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurements at Months 9 and 13.5. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score | Randomization (Baseline), Months 9 and 10.5 and 13.5 | All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF-EF Total Scores measurement at Months 9, 10.5 and 13.5. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain) | Randomization (Baseline), Months 9 and 10.5 and 13.5 | All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF domain scores measurements at Months 9, 10.5 and 13.5. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score | Months 9 and 13.5 | All randomized participants who received at least 1 dose of study drug and had EDITS mean scores measurements at Months 9 and 13.5. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score | Randomization (Baseline), Months 9 and 13.5 | All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEAR scores measurement at Months 9 and 13.5. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Global Assessment Questions (GAQ) Question 1 at Month 9 | Month 9 | All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 9. | participants | NUMBER |
| SECONDARY | Global Assessment Question (GAQ) Question 1 at Month 13.5 | Month 13.5 | All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 13.5. | participants | NUMBER |
| SECONDARY | Global Assessment Question (GAQ) Question 2 at Month 9 | Month 9 | All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 9. | participants | NUMBER |
| SECONDARY | Global Assessment Question (GAQ) Question 2 at Month 13.5 | Month 13.5 | All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 13.5. | participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group405
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire | Tadalafil 5 mg OaD | 20.9 | percentage of participants | ||
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire | Tadalafil 20 mg PRN | 16.9 | percentage of participants | ||
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire | Placebo | 19.1 | percentage of participants | ||
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain | Tadalafil 5 mg OaD | Month 9 | 25.2 | percentage of participants | |
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain | Tadalafil 20 mg PRN | Month 9 | 19.7 | percentage of participants | |
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain | Placebo | Month 9 | 14.2 | percentage of participants | |
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain | Tadalafil 5 mg OaD | Month 13.5 | 32.4 | percentage of participants | |
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain | Tadalafil 20 mg PRN | Month 13.5 | 33.1 | percentage of participants | |
| Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain | Placebo | Month 13.5 | 27.0 | percentage of participants | |
| Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score | Tadalafil 5 mg OaD | Month 9 | 7.73 | 95% Confidence Interval 5.73 to 9.73 | units on a scale |
1 to 10 of 405Source ClinicalTrials.gov
See all 405 results by groupParticipant flow52
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening Period | STARTED | Screen - BNSRP | 583 | |
| Screening Period | STARTED | Tadalafil 5 mg OaD | 0 | |
| Screening Period | STARTED | Tadalafil 20 mg PRN | 0 | |
| Screening Period | STARTED | Placebo | 0 | |
| Screening Period | COMPLETED | Screen - BNSRP | 423 | |
| Screening Period | COMPLETED | Tadalafil 5 mg OaD | 0 | |
| Screening Period | COMPLETED | Tadalafil 20 mg PRN | 0 | |
| Screening Period | COMPLETED | Placebo | 0 | |
| Screening Period | NOT COMPLETED | Screen - BNSRP | 160 | |
| Screening Period | NOT COMPLETED | Tadalafil 5 mg OaD | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 participant flowAdverse events1,827
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 | Screen - BNSRP | 5 | 583 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Tadalafil 5 mg OaD (Double-Blind Period/Washout Period) | 0 | 139 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Tadalafil 20 mg PRN (Double-Blind Period/Washout Period) | 0 | 143 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Double-Blind Period/Washout Period) | 0 | 141 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Tadalafil 5 mg OaD (Open-Label Period) | 0 | 139 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Tadalfil 20 mg PRN (Open-Label Period) | 0 | 143 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Open-Label Period) | 0 | 141 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Screen - BNSRP | 0 | 583 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Tadalafil 5 mg OaD (Double-Blind Period/Washout Period) | 1 | 139 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Tadalafil 20 mg PRN (Double-Blind Period/Washout Period) | 0 | 143 | 0 |
1 to 10 of 1,827Source ClinicalTrials.gov
See all 1,827 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Screen - BNSRP | ||
| Total, all-cause mortality | Tadalafil 5 mg OaD (Double-Blind Period/Washout Period) | ||
| Total, all-cause mortality | Tadalafil 20 mg PRN (Double-Blind Period/Washout Period) | ||
| Total, all-cause mortality | Placebo (Double-Blind Period/Washout Period) | ||
| Total, all-cause mortality | Tadalafil 5 mg OaD (Open-Label Period) | ||
| Total, all-cause mortality | Tadalfil 20 mg PRN (Open-Label Period) | ||
| Total, all-cause mortality | Placebo (Open-Label Period) | ||
| Total, other adverse events | Screen - BNSRP | 114 | 583 |
| Total, other adverse events | Tadalafil 5 mg OaD (Double-Blind Period/Washout Period) | 50 | 139 |
| Total, other adverse events | Tadalafil 20 mg PRN (Double-Blind Period/Washout Period) | 52 | 143 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers3
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/NCT01026818
GET https://conductscience.org/api/trials/v1/NCT01026818/registered?page=2