Trial · NCT01063881
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
NCT01063881, Phase 3, Completed, Janssen Research & Development, LLC; results first posted 2012-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy. Trials, record NCT01063881. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01063881
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
- NCT number
- NCT01063881
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 285 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Sexual Dysfunction, Physiological
- Interventions
- Dapoxetine
- First posted
- 2010-02-05
- Last updated
- 2024-11-19
- Results first posted
- 2012-10-31
- Limitations and caveats
Subgroup by dosage was categorized based on dose-titration patterns observed during the course of the treatment period. Patients were not randomized to treatment by dosage group, disease type, or Intravaginal Ejaculation Latency Time.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment | Week 12 | The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients who described improvement with their PE of at least "slightly better" after 12 weeks of treatment with dapoxetine are provided in the table below. |
| Secondary | The Patient's Level of Control Over Ejaculation | Baseline and Week 12 | The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of control over intercourse on a 5-point scale. Patients were asked: "Over the past month, was your level of control over ejaculation Very poor, Poor, Fair, Good, or Very Good?" The number of patients who rated their level of control over ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below. |
| Secondary | The Patient's Level of Satisfaction With Intercourse | Baseline and Week 12 | 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. Patients were asked: "Over the past month, was your satisfaction with sexual intercourse Very poor, Poor, Fair, Good, or Very Good?" The number of patients who rated their level of satisfaction with control over ejaculation at before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below. |
| Secondary | The Patient's Level of Personal Distress Related to the Speed of Ejaculation | Baseline and 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. Patient's were asked: "Over the past month, how distressed were you by how fast you ejaculated during sexual intercourse? Not at all, A little bit, Moderately, Quite a bit, Extremely." The number of patients who rated their level of personal distress related to the speed of ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below. |
| Secondary | The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation | Baseline and Week 12 | The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to the speed of ejaculation. Patient's were asked: "Over the past month, to what extent did how fast you/your partner ejaculated during sexual intercourse cause difficulty in your relationship with your partner? Not at all, A little bit, Moderately, Quite a bit, or Extremely?" The number of patients who rated their level of interpersonal difficulty before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below. |
| Secondary | Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine | Week 12 | The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients reporting improvement in their PE by category of the CGIC scale after 12 weeks of treatment with dapoxetine are provided in the table below. |
| Secondary | The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage) | Week 12 | The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment by the dose of dapoxetine they received in the study. This was a single-arm, open-label, non-randomized study in which "subgroup by dosage" was categorized based on dose-titration patterns observed during the course of the treatment period. |
| Secondary | The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type) | Week 12 | The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a "slightly better" response to treatment when grouped by type of PE disease (patients with life-long PE and patients with acquired PE). This was a single-arm, open-label, non-randomized study where patients were categorized based their PE disease after enrollment in the study. |
| Secondary | The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT]) | Week 12 | The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a "slightly better" response to treatment when grouped by intravaginal ejaculation latency time (patients with an IELT of \< 1 minute and patients with an IELT of \> 1 minute). This was a single-arm, open-label, non-randomized study where patients were categorized based on IELT after enrollment in the study. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment | Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
| SECONDARY | The Patient's Level of Control Over Ejaculation | Baseline and Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
| SECONDARY | The Patient's Level of Satisfaction With Intercourse | Baseline and Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
| SECONDARY | The Patient's Level of Personal Distress Related to the Speed of Ejaculation | Baseline and Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
| SECONDARY | The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation | Baseline and Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
| SECONDARY | Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine | Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
| SECONDARY | The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Dosage) | Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
| SECONDARY | The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Disease Type) | Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
| SECONDARY | The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT]) | Week 12 | The full analysis set (FAS) included all patients who took at least one dose of study drug and completed at least one assessment of efficacy. | Patients | NUMBER |
Source ClinicalTrials.gov
Results by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least Slightly Better in Response to Dapoxetine Treatment | Dapoxetine (Week 12) | 228 | Patients | ||
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Baseline) | Very poor | 120 | Patients | |
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Week 12) | Very poor | 22 | Patients | |
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Baseline) | Poor | 132 | Patients | |
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Week 12) | Poor | 57 | Patients | |
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Baseline) | Fair | 20 | Patients | |
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Week 12) | Fair | 77 | Patients | |
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Baseline) | Good | 2 | Patients | |
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Week 12) | Good | 101 | Patients | |
| The Patient's Level of Control Over Ejaculation | Dapoxetine (Baseline) | Very good | 0 | Patients |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dapoxetine 30 mg Only | 147 | |
| Overall Study | STARTED | Dapoxetine 30 to 60 mg | 125 | |
| Overall Study | STARTED | Dapoxetine 30 to 60 to 30 mg | 13 | |
| Overall Study | COMPLETED | Dapoxetine 30 mg Only | 92 | |
| Overall Study | COMPLETED | Dapoxetine 30 to 60 mg | 114 | |
| Overall Study | COMPLETED | Dapoxetine 30 to 60 to 30 mg | 12 | |
| Overall Study | NOT COMPLETED | Dapoxetine 30 mg Only | 55 | |
| Overall Study | NOT COMPLETED | Dapoxetine 30 to 60 mg | 11 | |
| Overall Study | NOT COMPLETED | Dapoxetine 30 to 60 to 30 mg | 1 |
Source ClinicalTrials.gov
Adverse events189
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 | Atrial Fibrillation | Cardiac disorders | Depoxetine (DPX) 30 mg Only | 1 | 144 | |
| other | Atrial Fibrillation | Cardiac disorders | Depoxetine (DPX) 30 to 60 mg | 0 | 124 | |
| other | Atrial Fibrillation | Cardiac disorders | Depoxetine (DPX) 30 to 60 to 30 mg | 0 | 13 | |
| other | Palpitations | Cardiac disorders | Depoxetine (DPX) 30 mg Only | 4 | 144 | |
| other | Palpitations | Cardiac disorders | Depoxetine (DPX) 30 to 60 mg | 3 | 124 | |
| other | Palpitations | Cardiac disorders | Depoxetine (DPX) 30 to 60 to 30 mg | 0 | 13 | |
| other | Vertigo | Ear and labyrinth disorders | Depoxetine (DPX) 30 mg Only | 0 | 144 | |
| other | Vertigo | Ear and labyrinth disorders | Depoxetine (DPX) 30 to 60 mg | 0 | 124 | |
| other | Vertigo | Ear and labyrinth disorders | Depoxetine (DPX) 30 to 60 to 30 mg | 1 | 13 | |
| other | Blepharitis | Eye disorders | Depoxetine (DPX) 30 mg Only | 0 | 144 |
1 to 10 of 189Source ClinicalTrials.gov
See all 189 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Depoxetine (DPX) 30 mg Only | ||
| Total, all-cause mortality | Depoxetine (DPX) 30 to 60 mg | ||
| Total, all-cause mortality | Depoxetine (DPX) 30 to 60 to 30 mg | ||
| Total, other adverse events | Depoxetine (DPX) 30 mg Only | 62 | 144 |
| Total, other adverse events | Depoxetine (DPX) 30 to 60 mg | 57 | 124 |
| Total, other adverse events | Depoxetine (DPX) 30 to 60 to 30 mg | 12 | 13 |
| Total, serious adverse events | Depoxetine (DPX) 30 mg Only | 2 | 144 |
| Total, serious adverse events | Depoxetine (DPX) 30 to 60 mg | 0 | 124 |
| Total, serious adverse events | Depoxetine (DPX) 30 to 60 to 30 mg | 0 | 13 |
Source ClinicalTrials.gov
Papers0
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
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