Trial · NCT01352507
A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China
NCT01352507, Phase 4, Completed, Eli Lilly and Company; results first posted 2013-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China. Trials, record NCT01352507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01352507
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China
- NCT number
- NCT01352507
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 383 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Erectile Dysfunction
- Interventions
- Tadalafil, Sildenafil
- First posted
- 2011-05-12
- Last updated
- 2013-04-26
- Results first posted
- 2013-04-26
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 Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the "Phosphodiesterase 5 Inhibitor Treatment Preference" Questionnaire (PITPQ) | Week 18 | PITPQ Question (Q) 1 was a dichotomous outcome measure in which the participant selected his preferred study treatment (tadalafil or sildenafil) to receive during the Extension Phase. |
| Secondary | Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ | Week 18 | PITPQ Q2 was a measure of the degree of treatment preference based on the participant's opinion. The question was, "For the treatment preference you selected in Q1, what is your degree of preference?". Choices were moderate or strong. |
| Secondary | Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain | Baseline, Week 8, and Week 18 | Self-reported overall satisfaction over the past 4 weeks. IIEF overall satisfaction was the sum of Q13 and Q14. Scores ranged from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF overall satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF overall satisfaction domain score. Higher IIEF overall satisfaction domain scores were indicative of greater overall satisfaction. |
| Secondary | Change in Sexual Encounter Profile (SEP) Question 2 | Baseline, Week 8, and Week 18 | Participant-assessed diary that assessed the mean change from baseline in the percentage of "yes" responses to SEP Q2, "Were you able to insert your penis into your partner's vagina?". The SEP Q2 score was determined as the percentage of "yes" responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus the percentage of "yes" responses at baseline. Change in percentage of "yes" responses to SEP Q2 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q2. |
| Secondary | Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain | Baseline, Week 8, and Week 18 | PAIRS was a self-administered, 29-item scale that assessed the broader psychological and interpersonal outcomes associated with ED and its treatment. Each question was rated on a Likert scale that ranged from 1 (strongly disagree) to 4 (strongly agree). The sexual self-confidence domain score was the average score for Items 5, 10, 15, 23, 27, and 29. Sexual self-confidence domain scores ranged from 1 (strongly disagree) to 4 (strongly agree). Change was defined as endpoint minus baseline domain score. Change in PAIRS sexual self-confidence domain scores at Week 8 and Week 18 were averaged to produce an overall change in PAIRS sexual self-confidence domain score. Higher scores were indicative of greater sexual self-confidence. |
| Secondary | Drug Attributes Questionnaire (DRAQ) at Week 18 | Week 18 | DRAQ was a questionnaire used to record explanations for why participants preferred a drug. Participants identified their first and second reasons for drug preference from a choice of 7 reasons. Each reason for drug preference includes participants who selected that reason as their first or second reason. |
| Secondary | Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain | Baseline, Week 8, and Week 18 | Self-reported intercourse satisfaction over the past 4 weeks. IIEF intercourse satisfaction was the sum of Q6, Q7, and Q8 of the IIEF. Scores ranged from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15. Change was defined as endpoint minus baseline domain score. Change in IIEF intercourse satisfaction domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF intercourse satisfaction domain score. Higher scores were indicative of an increase in intercourse satisfaction. |
| Secondary | Change in International Index of Erectile Function (IIEF) Sexual Desire Domain | Baseline, Week 8, and Week 18 | Self-reported sexual desire over the past 4 weeks. IIEF sexual desire was the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF sexual desire domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF sexual desire domain score. Higher scores were indicative of increased sexual desire. |
| Secondary | Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain | Baseline, Week 8, and Week 18 | Self-reported orgasmic function over the past 4 weeks. IIEF orgasmic function was the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Change was defined as endpoint minus baseline domain score. Change in IIEF orgasmic function domain at Week 8 and Week 18 were averaged to produce an overall change in IIEF orgasmic function domain score. Higher scores were indicative of better orgasmic function. |
| Secondary | Change in Sexual Encounter Profile (SEP) Question 3 | Baseline, Week 8, and Week 18 | Participant-assessed diary that assessed the mean change from baseline in the percentage of "yes" responses to SEP Q3, "Did your erection last long enough for you to have successful intercourse?". The SEP Q3 score was determined as the percentage of "yes" responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus percentage of "yes" responses at baseline. Change in the percentage of "yes" responses to SEP Q3 at Week 8 and Week 18 were averaged to produce an overall change in SEP Q3. |
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 Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the Phosphodiesterase 5 Inhibitor Treatment Preference Questionnaire (PITPQ) | Week 18 | Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ | Week 18 | Randomized participants who completed both treatment periods (Week 18), responded to the PITPQ, and were analyzed according to their assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain | Baseline, Week 8, and Week 18 | All randomized participants with baseline and at least 1 IIEF post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change in Sexual Encounter Profile (SEP) Question 2 | Baseline, Week 8, and Week 18 | Randomized participants with baseline and at least 1 post-baseline SEP measurement. | percentage of yes responses | MEAN |
| SECONDARY | Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain | Baseline, Week 8, and Week 18 | Randomized participants with baseline and at least 1 PAIRS post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Drug Attributes Questionnaire (DRAQ) at Week 18 | Week 18 | Randomized participants who completed both treatment periods (Week 18), responded to the DRAQ, and were analyzed according to their assigned treatment. | percentage of participants | NUMBER |
| SECONDARY | Change in International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain | Baseline, Week 8, and Week 18 | All randomized participants with baseline and at least 1 IIEF post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change in International Index of Erectile Function (IIEF) Sexual Desire Domain | Baseline, Week 8, and Week 18 | Randomized participants with baseline and at least 1 IIEF post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change in International Index of Erectile Function (IIEF) Orgasmic Function Domain | Baseline, Week 8, and Week 18 | Randomized participants with baseline and at least 1 IIEF post-baseline measurement. | units on a scale | MEAN |
| SECONDARY | Change in Sexual Encounter Profile (SEP) Question 3 | Baseline, Week 8, and Week 18 | Randomized participants with baseline and at least 1 SEP post-baseline measurement. | percentage of yes responses | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Preferring Tadalafil Over Sildenafil Measured at Week 18 Using Question 1 of the Phosphodiesterase 5 Inhibitor Treatment Preference Questionnaire (PITPQ) | All Randomized Participants | 69.1 | 95% Confidence Interval 64 to 74 | percentage of participants | |
| Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ | Tadalafil | Strong preference | 38.0 | percentage of participants | |
| Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ | Sildenafil | Strong preference | 34.3 | percentage of participants | |
| Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ | Tadalafil | Moderate preference | 62.0 | percentage of participants | |
| Percentage of Participants Moderately or Strongly Preferring the Selected Treatment at Week 18 Using Question 2 of the PITPQ | Sildenafil | Moderate preference | 65.7 | percentage of participants | |
| Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain | Tadalafil | 3.74 | Standard Deviation 1.94 | units on a scale | |
| Change in International Index of Erectile Function (IIEF) Overall Satisfaction Domain | Sildenafil | 3.71 | Standard Deviation 2.05 | units on a scale | |
| Change in Sexual Encounter Profile (SEP) Question 2 | Tadalafil | 45.28 | Standard Deviation 42.03 | percentage of yes responses | |
| Change in Sexual Encounter Profile (SEP) Question 2 | Sildenafil | 44.94 | Standard Deviation 41.62 | percentage of yes responses | |
| Change in Psychosocial and Interpersonal Relationship Scale (PAIRS) Sexual Self-Confidence Domain | Tadalafil | 0.75 | Standard Deviation 0.65 | units on a scale |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | Tadalafil Then Sildenafil | 190 | |
| Treatment Period 1 | STARTED | Sildenafil Then Tadalafil | 193 | |
| Treatment Period 1 | Received Treatment | Tadalafil Then Sildenafil | 182 | |
| Treatment Period 1 | Received Treatment | Sildenafil Then Tadalafil | 188 | |
| Treatment Period 1 | COMPLETED | Tadalafil Then Sildenafil | 176 | |
| Treatment Period 1 | COMPLETED | Sildenafil Then Tadalafil | 184 | |
| Treatment Period 1 | NOT COMPLETED | Tadalafil Then Sildenafil | 14 | |
| Treatment Period 1 | NOT COMPLETED | Sildenafil Then Tadalafil | 9 | |
| Washout Period | STARTED | Tadalafil Then Sildenafil | 176 | |
| Washout Period | STARTED | Sildenafil Then Tadalafil | 184 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events140
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 | Palpitations | Cardiac disorders | Tadalafil (Treatment Periods) | 1 | 363 | 1 |
| other | Palpitations | Cardiac disorders | Sildenafil (Treatment Periods) | 1 | 361 | 1 |
| other | Palpitations | Cardiac disorders | Tadalafil (Extension Phase) | 0 | 231 | 0 |
| other | Palpitations | Cardiac disorders | Sildenafil (Extension Phase) | 0 | 106 | 0 |
| other | Deafness | Ear and labyrinth disorders | Tadalafil (Treatment Periods) | 1 | 363 | 1 |
| other | Deafness | Ear and labyrinth disorders | Sildenafil (Treatment Periods) | 0 | 361 | 0 |
| other | Deafness | Ear and labyrinth disorders | Tadalafil (Extension Phase) | 0 | 231 | 0 |
| other | Deafness | Ear and labyrinth disorders | Sildenafil (Extension Phase) | 0 | 106 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Tadalafil (Treatment Periods) | 1 | 363 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Sildenafil (Treatment Periods) | 1 | 361 | 1 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tadalafil (Treatment Periods) | ||
| Total, all-cause mortality | Sildenafil (Treatment Periods) | ||
| Total, all-cause mortality | Tadalafil (Extension Phase) | ||
| Total, all-cause mortality | Sildenafil (Extension Phase) | ||
| Total, other adverse events | Tadalafil (Treatment Periods) | 30 | 363 |
| Total, other adverse events | Sildenafil (Treatment Periods) | 26 | 361 |
| Total, other adverse events | Tadalafil (Extension Phase) | 7 | 231 |
| Total, other adverse events | Sildenafil (Extension Phase) | 2 | 106 |
| Total, serious adverse events | Tadalafil (Treatment Periods) | 0 | 363 |
| Total, serious adverse events | Sildenafil (Treatment Periods) | 0 | 361 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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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