Trial · NCT01063855
Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction
NCT01063855, Phase 3, Completed, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2012-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction. Trials, record NCT01063855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01063855
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction
- NCT number
- NCT01063855
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 495 participants, actual
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Conditions
- Erectile Dysfunction, Sexual Dysfunction
- Interventions
- Placebo, Dapoxetine, PDE5I (phosphodiesterase-5 inhibitor)
- First posted
- 2010-02-05
- Last updated
- 2013-01-24
- Other registries' IDs
- eudract:2009-013616-12
- Results first posted
- 2012-11-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 | Baseline, Week 12 | The intravaginal ejaculatory latency time (IELT) is the time it takes for a man to ejaculate during sexual intercourse (as measured by stopwatch). The data below show the average IELT measured in minutes at Baseline (before treatment) to Endpoint (after 12 weeks of treatment). In this study, patients took placebo or dapoxetine along with a stable dose of a phosphodiesterase-5 inhibitor (PDE5I) prescribed prior to study entry for the treatment of erectile dysfunction. |
| Secondary | The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation | At the end of treatment (Week 12) | The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's control over ejaculation on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who reported at least a 2-category increase in control over ejaculation is provided in the table below. |
| Secondary | The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation | At Endpoint (After 12 weeks of treatment) | The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who achieved 1-category or greater decrease (improvement) in personal distress related to the speed of ejaculation is provided in the table below. |
| Secondary | The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress | At the end of treatment (Week 12) | The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation and control over ejaculation on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who reported a composite score of at least a 2-category increase in control over ejaculation and at least a 1-category decrease (improvement) in personal distress is provided in the table below. |
| Secondary | The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse | Endpoint (After 12 weeks of treatment) | The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who achieved 1-category or greater increase in satisfaction with sexual intercourse is provided in the table below. |
| Secondary | The Percentage of Patients Reporting At Least a "Better" Response to Treatment | Endpoint (After 12 weeks of treatment) | The "Clinical Global Impression of Change" (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from "Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better". The percentage of patients who reported improvement in PE of at least "better" at Endpoint (after 12 weeks of treatment) is provided in the table below. |
| Secondary | The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation | Endpoint (After 12 weeks of treatment) | The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to ejaculation on a 5-point scale from "Very poor, Poor, Fair, Good, to Very Good." The percentage of patients who reported at least a 1-category decrease (improvement) in interpersonal difficulty related to ejaculation is provided in the table below. |
| Secondary | The Percentage of Patients Reporting At Least a "Slightly Better" Response to Treatment | Endpoint (After 12 weeks of treatment) | The "Clinical Global Impression of Change" (CGIC) was used to assess the degree of improvement the patient experienced with premature ejaculation (PE) since initiating treatment with study drug on a 7-point scale from "Much worse, Worse, Slightly worse, No change, Slightly better, Better, to Much better". The percentage of patients who reported improvement in PE of at least "slightly better" at Endpoint (after 12 weeks of treatment) is provided in the table below. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 | Baseline, Week 12 | The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method. | minutes | MEAN |
| SECONDARY | The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation | At the end of treatment (Week 12) | The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method. | Percentage of Patients | NUMBER |
| SECONDARY | The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation | At Endpoint (After 12 weeks of treatment) | The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method. | Percentage of Patients | NUMBER |
| SECONDARY | The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress | At the end of treatment (Week 12) | The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method. | Percentage of Patients | NUMBER |
| SECONDARY | The Percentage of Patients Who Achieved a 1-category or Greater Increase in Satisfaction With Sexual Intercourse | Endpoint (After 12 weeks of treatment) | The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method. | Percentage of Patients | NUMBER |
| SECONDARY | The Percentage of Patients Reporting At Least a Better Response to Treatment | Endpoint (After 12 weeks of treatment) | The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method. | Percentage of Patients | NUMBER |
| SECONDARY | The Percentage of Patients Who Reported At Least a 1-category Decrease (Improvement) in Interpersonal Difficulty Related to Ejaculation | Endpoint (After 12 weeks of treatment) | The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method. | Percentage of Patients | NUMBER |
| SECONDARY | The Percentage of Patients Reporting At Least a Slightly Better Response to Treatment | Endpoint (After 12 weeks of treatment) | The intent-to-treat (ITT) analysis set included all randomized patients. Missing efficacy data at Week 12 was imputed based on the last postbaseline observation carried forward (LPOCF) method. | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 | PDE5I + Placebo (Baseline) | 1.1 | Standard Deviation 0.53 | minutes | |
| The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 | PDE5I + Placebo (Week 12) | 3.4 | Standard Deviation 3.54 | minutes | |
| The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 | PDE5I + Dapoxetine (Baseline) | 1.1 | Standard Deviation 0.55 | minutes | |
| The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 | PDE5I + Dapoxetine (Week 12) | 5.2 | Standard Deviation 5.78 | minutes | |
| The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation | PDE5I + Placebo | 32.3 | Percentage of Patients | ||
| The Percentage of Patients Reporting At Least a 2-category Increase in Control Over Ejaculation | PDE5I + Dapoxetine | 45.9 | Percentage of Patients | ||
| The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation | PDE5I + Placebo | 67.2 | Percentage of Patients | ||
| The Percentage of Patients Who Achieved 1-category or Greater Decrease (Improvement) in Personal Distress Related to Ejaculation | PDE5I + Dapoxetine | 76.4 | Percentage of Patients | ||
| The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress | PDE5I + Placebo | 30.6 | Percentage of Patients | ||
| The Percentage of Patients Reporting a Composite Score of At Least a 2-category Increase in Control Over Ejaculation and At Least a 1-category Decrease in Personal Distress | PDE5I + Dapoxetine | 43.5 | Percentage of Patients |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PDE5I + PLACEBO | 245 | |
| Overall Study | STARTED | PDE5I + DPX | 250 | |
| Overall Study | COMPLETED | PDE5I + PLACEBO | 208 | |
| Overall Study | COMPLETED | PDE5I + DPX | 221 | |
| Overall Study | NOT COMPLETED | PDE5I + PLACEBO | 37 | |
| Overall Study | NOT COMPLETED | PDE5I + DPX | 29 |
Source ClinicalTrials.gov
Adverse events204
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 | PDE5I + PLACEBO | 0 | 245 | |
| other | Palpitations | Cardiac disorders | PDE5I + DPX | 1 | 250 | |
| other | Phimosis | Congenital, familial and genetic disorders | PDE5I + PLACEBO | 1 | 245 | |
| other | Phimosis | Congenital, familial and genetic disorders | PDE5I + DPX | 0 | 250 | |
| other | Tinnitus | Ear and labyrinth disorders | PDE5I + PLACEBO | 1 | 245 | |
| other | Tinnitus | Ear and labyrinth disorders | PDE5I + DPX | 1 | 250 | |
| other | Vertigo | Ear and labyrinth disorders | PDE5I + PLACEBO | 1 | 245 | |
| other | Vertigo | Ear and labyrinth disorders | PDE5I + DPX | 4 | 250 | |
| other | Vertigo Positional | Ear and labyrinth disorders | PDE5I + PLACEBO | 1 | 245 | |
| other | Vertigo Positional | Ear and labyrinth disorders | PDE5I + DPX | 0 | 250 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PDE5I + PLACEBO | ||
| Total, all-cause mortality | PDE5I + DPX | ||
| Total, other adverse events | PDE5I + PLACEBO | 45 | 245 |
| Total, other adverse events | PDE5I + DPX | 73 | 250 |
| Total, serious adverse events | PDE5I + PLACEBO | 4 | 245 |
| Total, serious adverse events | PDE5I + DPX | 3 | 250 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23845016 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PDE5I + PLACEBO vs PDE5I + DPX: serious adverse events |
Source Trial comparisons
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/NCT01063855
GET https://conductscience.org/api/trials/v1/NCT01063855/events?page=2