Trial · NCT01130532
A Study in Erectile Dysfunction
NCT01130532, Phase 4, Completed, Eli Lilly and Company; results first posted 2013-01-04
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ConductScience Library. A Study in Erectile Dysfunction. Trials, record NCT01130532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01130532
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Erectile Dysfunction
- NCT number
- NCT01130532
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 623 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Erectile Dysfunction
- Interventions
- Tadalafil, Placebo
- First posted
- 2010-05-26
- Last updated
- 2013-01-04
- Results first posted
- 2013-01-04
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period) | Baseline through 12 weeks | Self-reported erectile function over 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), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III). |
| Secondary | Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score | Baseline, 12 weeks | Self-reported erectile function over 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), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction. |
| Secondary | Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score | Baseline, 12 weeks | Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction. |
| Secondary | Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score | Baseline, 12 weeks | Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction. |
| Secondary | Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5 | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction. |
| Secondary | Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient | Baseline, 12 weeks | The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction. |
| Secondary | Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint | Week 12 | The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study. |
| Secondary | Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence) | Baseline, 12 weeks | Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction. |
| Secondary | Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner | Baseline, 12 weeks | The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction. |
| Secondary | Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint | Week 12 | The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period) | Baseline through 12 weeks | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score | Baseline, 12 weeks | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score | Baseline, 12 weeks | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score | Baseline, 12 weeks | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12-Week in Percentage of Yes Responses to Sexual Encounter Profile (SEP) Questions 1-5 | Baseline, 12 weeks | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | percentage of yes responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient | Baseline, 12 weeks | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint | Week 12 | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence) | Baseline, 12 weeks | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner | Baseline, 12 weeks | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's TSS measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint | Week 12 | All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 (normal) at baseline. Last observation carried forward (LOCF) principle was used. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period) | 2.5 mg Titrated to 5 mg Tadalafil (Period III) | 38.7 | percentage of participants | ||
Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period) | 5 mg Tadalafil (Period III) | 39.6 | percentage of participants | ||
Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period) | Placebo (Period III) | 12.1 | percentage of participants | ||
| Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score | 2.5 mg Titrated to 5 mg Tadalafil (Period III) | 7.9 | Standard Error 0.49 | units on a scale | |
| Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score | 5 mg Tadalafil (Period III) | 8.1 | Standard Error 0.49 | units on a scale | |
| Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score | Placebo (Period III) | 1.8 | Standard Error 0.49 | units on a scale | |
| Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score | 2.5 mg Titrated to 5 mg Tadalafil (Period III) | 2.8 | Standard Error 0.21 | units on a scale | |
| Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score | 5 mg Tadalafil (Period III) | 2.6 | Standard Error 0.21 | units on a scale | |
| Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score | Placebo (Period III) | 0.6 | Standard Error 0.21 | units on a scale | |
| Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score | 2.5 mg Titrated to 5 mg Tadalafil (Period III) | 2.4 | Standard Error 0.16 | units on a scale |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow32
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period III (Weeks 0-12) | STARTED | 2.5 mg Titrated to 5 mg Tadalafil | 207 | |
| Period III (Weeks 0-12) | STARTED | 5 mg Tadalafil | 207 | |
| Period III (Weeks 0-12) | STARTED | Placebo | 209 | |
| Period III (Weeks 0-12) | STARTED | 5 mg Tadalafil Open-Label Extension | 0 | |
| Period III (Weeks 0-12) | Received at Least 1 Dose of Study Drug | 2.5 mg Titrated to 5 mg Tadalafil | 205 | |
| Period III (Weeks 0-12) | Received at Least 1 Dose of Study Drug | 5 mg Tadalafil | 205 | |
| Period III (Weeks 0-12) | Received at Least 1 Dose of Study Drug | Placebo | 207 | |
| Period III (Weeks 0-12) | Received at Least 1 Dose of Study Drug | 5 mg Tadalafil Open-Label Extension | 0 | |
| Period III (Weeks 0-12) | COMPLETED | 2.5 mg Titrated to 5 mg Tadalafil | 186 | |
| Period III (Weeks 0-12) | COMPLETED | 5 mg Tadalafil | 189 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 participant flowAdverse events684
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 | 2.5 mg Titrated to 5 mg Tadalafil | 0 | 205 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 5 mg Tadalafil | 1 | 205 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 207 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | 5 mg Tadalafil Open-Label Extension | 1 | 546 | 1 |
| other | Palpitations | Cardiac disorders | 2.5 mg Titrated to 5 mg Tadalafil | 0 | 205 | 0 |
| other | Palpitations | Cardiac disorders | 5 mg Tadalafil | 1 | 205 | 1 |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 207 | 0 |
| other | Palpitations | Cardiac disorders | 5 mg Tadalafil Open-Label Extension | 0 | 546 | 0 |
| other | Supraventricular tachycardia | Cardiac disorders | 2.5 mg Titrated to 5 mg Tadalafil | 0 | 205 | 0 |
| other | Supraventricular tachycardia | Cardiac disorders | 5 mg Tadalafil | 0 | 205 | 0 |
1 to 10 of 684Source ClinicalTrials.gov
See all 684 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 2.5 mg Titrated to 5 mg Tadalafil | ||
| Total, all-cause mortality | 5 mg Tadalafil | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | 5 mg Tadalafil Open-Label Extension | ||
| Total, other adverse events | 2.5 mg Titrated to 5 mg Tadalafil | 46 | 205 |
| Total, other adverse events | 5 mg Tadalafil | 68 | 205 |
| Total, other adverse events | Placebo | 50 | 207 |
| Total, other adverse events | 5 mg Tadalafil Open-Label Extension | 23 | 546 |
| Total, serious adverse events | 2.5 mg Titrated to 5 mg Tadalafil | 1 | 205 |
| Total, serious adverse events | 5 mg Tadalafil | 1 | 205 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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.
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