Trial · NCT00734604
A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
NCT00734604, Phase 3, Completed, Eli Lilly and Company; results first posted 2010-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes. Trials, record NCT00734604. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00734604
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.
- NCT number
- NCT00734604
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 378 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Erectile Dysfunction
- Interventions
- tadalafil once a day [T(OaD)], sildenafil citrate as needed [S(PRN)], tadalafil as needed [T(PRN)]
- First posted
- 2008-08-14
- Last updated
- 2010-11-18
- Results first posted
- 2010-11-18
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | baseline, 8 weeks of each treatment | The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence. |
| Secondary | Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | baseline, 8 weeks of each treatment | The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence. |
| Secondary | Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | baseline, 8 weeks of each treatment | The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity. |
| Secondary | Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | baseline, 8 weeks of each treatment | The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence. |
| Secondary | Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | baseline, 8 weeks of each treatment | Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30. |
| Secondary | Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection | baseline, 8 weeks of each treatment | |
| Secondary | Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | baseline, 8 weeks of each treatment | Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15. |
| Secondary | Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | baseline, 8 weeks of each treatment | Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10. |
| Secondary | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint | 8 weeks of each treatment | EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction). |
| Secondary | Number of Participants With at Least One Serious Adverse Event | baseline through 26 weeks (including two washout periods of 1 week each) | Serious adverse events are listed in the Reported Adverse Event module. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | baseline, 8 weeks of each treatment | units on a scale | MEAN | |
| SECONDARY | Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | baseline, 8 weeks of each treatment | units on a scale | MEAN | |
| SECONDARY | Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | baseline, 8 weeks of each treatment | units on a scale | MEAN | |
| SECONDARY | Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | baseline, 8 weeks of each treatment | units on a scale | MEAN | |
| SECONDARY | Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | baseline, 8 weeks of each treatment | units on a scale | MEAN | |
| SECONDARY | Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection | baseline, 8 weeks of each treatment | proportion of days | MEAN | |
| SECONDARY | Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | baseline, 8 weeks of each treatment | units on a scale | MEAN | |
| SECONDARY | Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | baseline, 8 weeks of each treatment | units on a scale | MEAN | |
| SECONDARY | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint | 8 weeks of each treatment | units on a scale | MEAN | |
| SECONDARY | Number of Participants With at Least One Serious Adverse Event | baseline through 26 weeks (including two washout periods of 1 week each) | participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Tadalafil Once a Day [T(OaD)] | Baseline | 2.24 | Standard Deviation 0.62 | units on a scale |
| Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Sildenafil as Needed [S(PRN)] | Baseline | 2.23 | Standard Deviation 0.63 | units on a scale |
| Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Tadalafil Once a Day [T(OaD)] | Change from Baseline | 0.50 | Standard Deviation 0.78 | units on a scale |
| Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Sildenafil as Needed [S(PRN)] | Change from Baseline | 0.39 | Standard Deviation 0.67 | units on a scale |
| Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Tadalafil Once a Day [T(OaD)] | Baseline | 2.24 | Standard Deviation 0.62 | units on a scale |
| Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Tadalafil as Needed [T(PRN)] | Baseline | 2.24 | Standard Deviation 0.63 | units on a scale |
| Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Tadalafil Once a Day [T(OaD)] | Change from Baseline | 0.50 | Standard Deviation 0.78 | units on a scale |
| Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Tadalafil as Needed [T(PRN)] | Change from Baseline | 0.50 | Standard Deviation 0.72 | units on a scale |
| Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | Tadalafil Once a Day [T(OaD)] | Baseline | 3.06 | Standard Deviation 0.48 | units on a scale |
| Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | Sildenafil as Needed [S(PRN)] | Baseline | 3.07 | Standard Deviation 0.48 | units on a scale |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T(OaD)/S(PRN)/T(PRN) | 62 | |
| Overall Study | STARTED | T(OaD)/T(PRN)/S(PRN) | 63 | |
| Overall Study | STARTED | S(PRN)/T(OaD)/T(PRN) | 63 | |
| Overall Study | STARTED | S(PRN)/T(PRN)/T(OaD) | 63 | |
| Overall Study | STARTED | T(PRN)/T(OaD)/S(PRN) | 63 | |
| Overall Study | STARTED | T(PRN)/S(PRN)/T(OaD) | 64 | |
| Overall Study | COMPLETED | T(OaD)/S(PRN)/T(PRN) | 59 | |
| Overall Study | COMPLETED | T(OaD)/T(PRN)/S(PRN) | 51 | |
| Overall Study | COMPLETED | S(PRN)/T(OaD)/T(PRN) | 57 | |
| Overall Study | COMPLETED | S(PRN)/T(PRN)/T(OaD) | 54 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events324
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 Once a Day [T(OaD)] | 0 | 378 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Sildenafil Citrate as Needed [S(PRN)] | 1 | 378 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Tadalafil as Needed [T(PRN)] | 1 | 378 | 1 |
| other | Myocardial ischaemia | Cardiac disorders | Tadalafil Once a Day [T(OaD)] | 0 | 378 | 0 |
| other | Myocardial ischaemia | Cardiac disorders | Sildenafil Citrate as Needed [S(PRN)] | 1 | 378 | 1 |
| other | Myocardial ischaemia | Cardiac disorders | Tadalafil as Needed [T(PRN)] | 0 | 378 | 0 |
| other | Tachycardia | Cardiac disorders | Tadalafil Once a Day [T(OaD)] | 1 | 378 | 1 |
| other | Tachycardia | Cardiac disorders | Sildenafil Citrate as Needed [S(PRN)] | 1 | 378 | 1 |
| other | Tachycardia | Cardiac disorders | Tadalafil as Needed [T(PRN)] | 0 | 378 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Tadalafil Once a Day [T(OaD)] | 1 | 378 | 1 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tadalafil Once a Day [T(OaD)] | ||
| Total, all-cause mortality | Sildenafil Citrate as Needed [S(PRN)] | ||
| Total, all-cause mortality | Tadalafil as Needed [T(PRN)] | ||
| Total, other adverse events | Tadalafil Once a Day [T(OaD)] | 66 | 378 |
| Total, other adverse events | Sildenafil Citrate as Needed [S(PRN)] | 73 | 378 |
| Total, other adverse events | Tadalafil as Needed [T(PRN)] | 70 | 378 |
| Total, serious adverse events | Tadalafil Once a Day [T(OaD)] | 4 | 378 |
| Total, serious adverse events | Sildenafil Citrate as Needed [S(PRN)] | 5 | 378 |
| Total, serious adverse events | Tadalafil as Needed [T(PRN)] | 2 | 378 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22429760 | 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
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