Trial · NCT01037218
Treatment of Erectile Dysfunction II
NCT01037218, Phase 3, Completed, Warner Chilcott; results first posted 2011-12-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Treatment of Erectile Dysfunction II. Trials, record NCT01037218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01037218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Erectile Dysfunction II
- NCT number
- NCT01037218
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 601 participants, actual
- Lead sponsor
- Warner Chilcott
- Conditions
- Erectile Dysfunction
- Interventions
- Udenafil, Placebo
- First posted
- 2009-12-22
- Last updated
- 2015-06-19
- Results first posted
- 2011-12-22
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Baseline and Week 12 | Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get \& keep your erection? |
| Primary | Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Baseline and Weeks 1-12 | Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. |
| Primary | Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Baseline and Weeks 1-12 | Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period. |
| Secondary | Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse? |
| Secondary | Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)? |
| Secondary | Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire? |
| Secondary | Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner? |
| Secondary | Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population | Week 12 | While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders) |
| Secondary | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT | Baseline and Week 12 | EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness? |
| Secondary | Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population | Baseline and Week 12 | PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity |
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 | Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Baseline and Week 12 | mITT, LOCF | Units on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Baseline and Weeks 1-12 | mITT | Percentage of Yes Reponses | LEAST_SQUARES_MEAN |
| PRIMARY | Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Baseline and Weeks 1-12 | mITT | Percentage of Yes Responses | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | mITT, LOCF | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | mITT, LOCF | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | mITT, LOCF | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Baseline and Week 12 | mITT, LOCF | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population | Week 12 | mITT | Yes Responders | NUMBER |
| SECONDARY | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT | Baseline and Week 12 | mITT, LOCF | Units on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population | Baseline and Week 12 | mITT | Units on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Udenafil 50 mg | 3.79 | 95% Confidence Interval 2.58 to 5.00 | Units on a Scale | |
Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Udenafil 100 mg | 6.14 | 95% Confidence Interval 4.92 to 7.37 | Units on a Scale | |
Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Udenafil 150mg | 7.94 | 95% Confidence Interval 6.75 to 9.12 | Units on a Scale | |
Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Placebo | 0.41 | 95% Confidence Interval -0.81 to 1.62 | Units on a Scale | |
| Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Udenafil 50 mg | 14.47 | 95% Confidence Interval 9.60 to 19.33 | Percentage of Yes Reponses | |
| Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Udenafil 100 mg | 19.34 | 95% Confidence Interval 14.46 to 24.23 | Percentage of Yes Reponses | |
| Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Udenafil 150mg | 27.12 | 95% Confidence Interval 22.39 to 31.85 | Percentage of Yes Reponses | |
| Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Placebo | -5.72 | 95% Confidence Interval -10.57 to -0.86 | Percentage of Yes Reponses | |
| Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Udenafil 50 mg | 33.24 | 95% Confidence Interval 27.81 to 38.67 | Percentage of Yes Responses | |
| Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Udenafil 100 mg | 38.34 | 95% Confidence Interval 32.89 to 43.80 | Percentage of Yes Responses |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Udenafil 50 mg | 147 | |
| Overall Study | STARTED | Udenafil 100 mg | 149 | |
| Overall Study | STARTED | Udenafil 150mg | 155 | |
| Overall Study | STARTED | Placebo | 150 | |
| Overall Study | Safety Population | Udenafil 50 mg | 147 | |
| Overall Study | Safety Population | Udenafil 100 mg | 148 | |
| Overall Study | Safety Population | Udenafil 150mg | 154 | |
| Overall Study | Safety Population | Placebo | 150 | |
| Overall Study | mITT Population | Udenafil 50 mg | 141 | |
| Overall Study | mITT Population | Udenafil 100 mg | 140 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events64
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 | Upper Respiratory Tract Infection | Infections and infestations | Udenafil 50 mg | 7 | 147 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Udenafil 100 mg | 7 | 148 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Udenafil 150mg | 6 | 150 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo | 0 | 150 | |
| other | Nasopharyngitis | Infections and infestations | Udenafil 50 mg | 6 | 147 | |
| other | Nasopharyngitis | Infections and infestations | Udenafil 100 mg | 2 | 148 | |
| other | Nasopharyngitis | Infections and infestations | Udenafil 150mg | 5 | 150 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 5 | 150 | |
| other | Sinusitis | Infections and infestations | Udenafil 50 mg | 2 | 147 | |
| other | Sinusitis | Infections and infestations | Udenafil 100 mg | 4 | 148 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Udenafil 50 mg | ||
| Total, all-cause mortality | Udenafil 100 mg | ||
| Total, all-cause mortality | Udenafil 150mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Udenafil 50 mg | 43 | 147 |
| Total, other adverse events | Udenafil 100 mg | 51 | 148 |
| Total, other adverse events | Udenafil 150mg | 49 | 150 |
| Total, other adverse events | Placebo | 11 | 150 |
| Total, serious adverse events | Udenafil 50 mg | 1 | 147 |
| Total, serious adverse events | Udenafil 100 mg | 1 | 148 |
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.
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/NCT01037218
GET https://conductscience.org/api/trials/v1/NCT01037218/results?page=2