Trial · NCT01122264
A Study in Patients With Erectile Dysfunction
NCT01122264, Phase 4, Completed, Eli Lilly and Company; results first posted 2012-10-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Patients With Erectile Dysfunction. Trials, record NCT01122264. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01122264
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Patients With Erectile Dysfunction
- NCT number
- NCT01122264
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 770 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Erectile Dysfunction
- Interventions
- Tadalafil, Sildenafil Citrate
- First posted
- 2010-05-13
- Last updated
- 2012-10-19
- Results first posted
- 2012-10-19
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Discontinuation of Randomized Treatment | Baseline up to 334 days | Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method. |
| Secondary | Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Baseline, 4, 8, 16, and 24 weeks | Self-reported EF score over past 4 weeks. Items 1-5 scores range from 0 (no sexual activity) to 5 (high EF). Item 15 score ranges from 1 (very low confidence to get/keep erection) to 5 (very high confidence). Total scores range from 1 to 30; lower scores denote greater erectile dysfunction severity. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis included terms for baseline score, treatment group, country, baseline\*treatment (if p\<0.10), visit, and visit\*treatment. Correlation matrix for repeated observations assumed to be unstructured. |
| Secondary | Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain | Baseline, 4, 8, 16, and 24 weeks | Self-reported orgasmic function on the IIEF over past 4 weeks and consists of 2 questions (items 9 and 10). Each question is rated on a scale from 0 (no sexual stimulation) to 5 (almost always/always). Total scores range from 0 to 10; lower scores represent lower orgasmic function. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline\*treatment (if p\<0.10), visit, and visit\*treatment. The correlation matrix for the repeated observations was assumed to be unstructured. |
| Secondary | Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain | Baseline, 4, 8, 16, and 24 weeks | Self-reported sexual desire on IIEF over past 4 weeks; comprises 2 questions (items 11 and 12). Each question rated on a scale from 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). Total scores range: 2 to 10; lower numerical scores denote lower sexual desire. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline\*treatment (if p\<0.10), visit, and visit\*treatment. Correlation matrix for repeated observations assumed to be unstructured. |
| Secondary | Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP) | Baseline, 4, 8, 16, and 24 weeks | Participant-assessed diary. Has 5 questions (Question\[Q\]1:erection achievement, Q2:successful penetration, Q3:successful intercourse, Q4:satisfied with erection, and Q5:satisfied with sexual experience) for each sexual encounter made over specified period of time. SEP Q1-Q5 scores determined as percentage of 'Yes' responses to each of 5 questions out of all sexual attempts recorded during the time period. Least Squares Mean changes from baseline to endpoint for each visit from a repeated measures analysis included terms for baseline score, treatment group, country, visit, and visit\*treatment. |
| Secondary | Global Assessment Questions (GAQ) | 24 weeks | The GAQ consists of 2 Yes/No/No Response (No Respo) questions. GAQ Question (Q)1: Has the treatment you have been taking during this study improved your erections? GAQ Q2: Has the treatment improved your ability to engage in sexual activity? |
| Secondary | Number of Treatment Switches | Baseline through 24 weeks | The number of times participants switched erectile dysfunction medication within the 3 treatments being studied (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand). |
| Secondary | Patterns of Erectile Dysfunction Treatment Change | Baseline through 24 weeks | Results are reported as the number of participants per sequence of study medications (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) that were taken as a result of switching treatments. The Other Treatment Sequence reports the number of participants per sequence of study medications that were taken as a result of switching treatments more than once. The number of participants who did not switch is also reported. |
| Secondary | Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment | Baseline through 24 weeks | The reported reasons for a decision to discontinue from initial randomized treatment prior to Week 24 are reported. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered as switching of treatment. |
| Secondary | Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments | 8 weeks up to 334 days | The differences in time between the 8-week time point and the discontinuation of all study treatments (that is, discontinuation from the study and not switching to another treatment) are reported by the median (95% confidence interval). Duration was measured as the number of days from Week 8 to the date of the last dose of the study drug. This outcome measure was estimated using the Kaplan-Meier product-limit method. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Discontinuation of Randomized Treatment | Baseline up to 334 days | The analysis included all randomly assigned participants. | days | MEDIAN |
| SECONDARY | Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Baseline, 4, 8, 16, and 24 weeks | The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF-EF observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain | Baseline, 4, 8, 16, and 24 weeks | The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Orgasmic Function observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain | Baseline, 4, 8, 16, and 24 weeks | The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Sexual Desire observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP) | Baseline, 4, 8, 16, and 24 weeks | The analysis included all randomly assigned participants who had a baseline and post-baseline SEP observation. | percentage of yes responses | LEAST_SQUARES_MEAN |
| SECONDARY | Global Assessment Questions (GAQ) | 24 weeks | The analysis included all randomly assigned participants. The last available GAQ assessment for each participant was used in the analysis. | participants | NUMBER |
| SECONDARY | Number of Treatment Switches | Baseline through 24 weeks | The analysis included all randomly assigned participants who switched erectile dysfunction medication and had a baseline and post-baseline observation. | number of treatment switches | MEAN |
| SECONDARY | Patterns of Erectile Dysfunction Treatment Change | Baseline through 24 weeks | All randomly assigned participants were included in the analysis. | participants | NUMBER |
| SECONDARY | Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment | Baseline through 24 weeks | The analysis included all randomly assigned participants. | participants | NUMBER |
| SECONDARY | Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments | 8 weeks up to 334 days | The analysis included all randomly assigned participants who completed the 8-week randomized treatment. | days | MEDIAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group268
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Discontinuation of Randomized Treatment | Tadalafil On Demand | NA | 95% Confidence Interval 187 to NA | days | |
| Time to Discontinuation of Randomized Treatment | Tadalafil Once a Day | 130 | 95% Confidence Interval 113 to NA | days | |
| Time to Discontinuation of Randomized Treatment | Sildenafil Citrate On Demand | 67 | 95% Confidence Interval 64 to 77 | days | |
| Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Tadalafil On Demand | Change from Baseline to Week 4 | 7.92 | Standard Error 0.44 | units on a scale |
| Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Tadalafil Once a Day | Change from Baseline to Week 4 | 8.60 | Standard Error 0.43 | units on a scale |
| Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Sildenafil Citrate On Demand | Change from Baseline to Week 4 | 8.86 | Standard Error 0.43 | units on a scale |
| Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Tadalafil On Demand | Change from Baseline to Week 8 (n=231, 232, 232) | 8.98 | Standard Error 0.45 | units on a scale |
| Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Tadalafil Once a Day | Change from Baseline to Week 8 (n=231, 232, 232) | 9.08 | Standard Error 0.45 | units on a scale |
| Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Sildenafil Citrate On Demand | Change from Baseline to Week 8 (n=231, 232, 232) | 9.70 | Standard Error 0.44 | units on a scale |
| Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain | Tadalafil On Demand | Change from Baseline to Week 16 (n=167, 146, 101) | 10.60 | Standard Error 0.41 | units on a scale |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tadalafil On Demand | 252 | |
| Overall Study | STARTED | Tadalafil Once a Day | 257 | |
| Overall Study | STARTED | Sildenafil Citrate On Demand | 261 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tadalafil On Demand | 250 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Tadalafil Once a Day | 257 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Sildenafil Citrate On Demand | 260 | |
| Overall Study | COMPLETED | Tadalafil On Demand | 220 | |
| Overall Study | COMPLETED | Tadalafil Once a Day | 228 | |
| Overall Study | COMPLETED | Sildenafil Citrate On Demand | 214 | |
| Overall Study | NOT COMPLETED | Tadalafil On Demand | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events111
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 | Gastrointestinal disorders | Gastrointestinal disorders | Tadalafil On Demand | 21 | 250 | 52 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Tadalafil Once a Day | 30 | 257 | 79 |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Sildenafil Citrate On Demand | 10 | 260 | 32 |
| other | Infections and infestations | Infections and infestations | Tadalafil On Demand | 17 | 250 | 27 |
| other | Infections and infestations | Infections and infestations | Tadalafil Once a Day | 10 | 257 | 22 |
| other | Infections and infestations | Infections and infestations | Sildenafil Citrate On Demand | 10 | 260 | 17 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Tadalafil On Demand | 44 | 250 | 117 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Tadalafil Once a Day | 19 | 257 | 51 |
| other | Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Sildenafil Citrate On Demand | 40 | 260 | 110 |
| other | Intentional overdose | Injury, poisoning and procedural complications | Tadalafil On Demand | 16 | 250 | 40 |
1 to 10 of 111Source ClinicalTrials.gov
See all 111 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tadalafil On Demand | ||
| Total, all-cause mortality | Tadalafil Once a Day | ||
| Total, all-cause mortality | Sildenafil Citrate On Demand | ||
| Total, other adverse events | Tadalafil On Demand | 106 | 250 |
| Total, other adverse events | Tadalafil Once a Day | 80 | 257 |
| Total, other adverse events | Sildenafil Citrate On Demand | 103 | 260 |
| Total, serious adverse events | Tadalafil On Demand | 8 | 250 |
| Total, serious adverse events | Tadalafil Once a Day | 4 | 257 |
| Total, serious adverse events | Sildenafil Citrate On Demand | 2 | 260 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23551622 | DERIVED |
Source PubMed
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.
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