A Phase 3 interventional study of Dapoxetine in Sexual Dysfunction, Physiological, sponsored by Janssen Research & Development, LLC. Completed at 13 sites in 3 countries. Open to male participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.
This is a prospective, interventional study to evaluate efficacy and safety of flexible dose dapoxetine as Premature Ejaculation (PE) Therapy. The total study duration will be 16 weeks, composed of a 2-week pretreatment phase and a 12-week open-label treatment phase, followed by a telephone contact two weeks after Week 12 to follow-up adverse events. At Visit 1 (Screening) standardized assessment tool or patient questionnaires will be used to determine which of those patients with erectile dysfunction/premature ejaculation are eligible to participate in this study. Once enrolled the patient and his partner are expected to attempt sexual intercourse a minimum of 2 times (at least 24 hours apart) and to complete a Baseline Event Log. Starting at Visit 2 (Baseline), the patient (and partner) will complete the Premature Ejaculation Profile (PEP) at the beginning of every treatment visit for the duration of the study. Patients will be started on study drug instructed to take 1 tablet of dapoxetine 30 mg, as needed, 1 to 3 hours prior to sexual activity. The need for adjustments in the dose of dapoxetine, as well as to assess the occurrence of adverse events and concomitant therapy use will be assessed approximately every 4 weeks. Patients will complete Treatment Event Logs during each dosing throughout the open-label treatment phase. Patients who have their dose increased to 60 mg, will be scheduled for a telephone consultation 1 week after to determine how the dose change is tolerated. At Visit 5 (Final Visit/Week 12/Early Termination), the patients and partners will complete several standardized assessment questionnaires have all final visit procedures performed and schedule a telephone follow up contact to evaluate any adverse events. The starting dose of dapoxetine is 30 mg (one 30-mg tablet), taken approximately 1 to 3 hours prior to sexual activity. The dose may be increased after 4 weeks to 60 mg taken. The maximum recommended dosing frequency is once every 24 hours.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 285 is above the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Compared within Premature Ejaculation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sexual Dysfunction, Physiological. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity may be increased after 4 weeks to 60mg taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.
Drug: Dapoxetine
Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment
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.
Time frame: Week 12
The Patient's Level of Control Over Ejaculation
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.
Time frame: Baseline and Week 12
The Patient's Level of Satisfaction With Intercourse
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.
Time frame: Baseline and Week 12
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
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.
Time frame: Baseline and Week 12
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
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.
Time frame: Baseline and Week 12
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
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.
Time frame: Week 12
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage)
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.
Time frame: Week 12
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type)
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.
Time frame: Week 12
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])
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.
Time frame: Week 12
A total of 285 patients were enrolled in the study, of which 281 patients received at least 1 dose of study drug were included in the safety analysis set (Dapoxetine 30 mg only \[144 patients\], Dapoxetine 30 t0 60 mg \[124 patients\] and Dapoxetine 30 to 60 to 30 mg \[13 patients\]).
| Milestone | Dapoxetine 30 mg Only | Dapoxetine 30 to 60 mg | Dapoxetine 30 to 60 to 30 mg |
|---|---|---|---|
| Started | 147 | 125 | 13 |
| Completed | 92 | 114 | 12 |
| Not completed | 55 | 11 | 1 |
| Withdrew: Adverse event | 12 | 2 | 0 |
| Withdrew: Lost to follow-up | 13 | 7 | 1 |
| Withdrew: Withdrawal by subject | 25 | 1 | 0 |
| Withdrew: Reason for not completed not specified | 5 | 1 | 0 |
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.
| Patients | Dapoxetine (Week 12) |
|---|---|
| The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment | 228 |
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.
| Patients | Dapoxetine (Baseline) | Dapoxetine (Week 12) |
|---|---|---|
| Very poor | 120 | 22 |
| Poor | 132 | 57 |
| Fair | 20 | 77 |
| Good | 2 | 101 |
| Very good | 0 | 21 |
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.
| Patients | Dapoxetine (Baseline) | Dapoxetine (Week 12) |
|---|---|---|
| Very poor | 63 | 14 |
| Poor | 152 | 40 |
| Fair | 53 | 89 |
| Good | 6 | 105 |
| Very good | 0 | 30 |
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.
| Patients | Dapoxetine (Baseline) | Dapoxetine (Week 12) |
|---|---|---|
| Not at all | 2 | 66 |
| A little bit | 32 | 89 |
| Moderately | 32 | 66 |
| Quite a bit | 140 | 40 |
| Extremely | 68 | 17 |
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.
| Patients | Dapoxetine (Baseline) | Dapoxetine (Week 12) |
|---|---|---|
| Not at all | 12 | 87 |
| A little bit | 40 | 82 |
| Moderately | 78 | 65 |
| Quite a bit | 113 | 37 |
| Extremely | 31 | 7 |
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.
| Patients | Dapoxetine (Week 12) |
|---|---|
| Much worse | 0 |
| Worse | 0 |
| Slightly worse | 4 |
| No change | 25 |
| Slightly better | 94 |
| Better | 101 |
| Much better | 33 |
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.
| Patients | Dapoxetine 30 mg Only | Dapoxetine 30 to 60 mg | Dapoxetine 30 to 60 to 30 mg |
|---|---|---|---|
| The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage) | 109 | 107 | 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.
| Patients | Dapoxetine (Patients With Life-long PE, Week 12) | Dapoxetine (Patients With Acquired PE, Week 12) |
|---|---|---|
| The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type) | 95 | 133 |
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.
| Patients | Dapoxetine (Patients With IELT <1 Minute, Week 12) | Dapoxetine (Patients With IELT >1 Minute, Week 12) |
|---|---|---|
| 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]) | 110 | 118 |
Collected over Adverse events were reported for the duration of the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Depoxetine (DPX) 30 mg Only | — | 2/144 (1.4%) | 62/144 (43.1%) |
| Depoxetine (DPX) 30 to 60 mg | — | 0/124 (0%) | 57/124 (46%) |
| Depoxetine (DPX) 30 to 60 to 30 mg | — | 0/13 (0%) | 12/13 (92.3%) |
| Event | Depoxetine (DPX) 30 mg Only | Depoxetine (DPX) 30 to 60 mg | Depoxetine (DPX) 30 to 60 to 30 mg |
|---|---|---|---|
| Facial Bones FractureInjury, poisoning and procedural complications | 1/144 | 0/124 | 0/13 |
| Road Traffic AccidentInjury, poisoning and procedural complications | 1/144 | 0/124 | 0/13 |
| DizzinessNervous system disorders | 1/144 | 0/124 | 0/13 |
| Event | Depoxetine (DPX) 30 mg Only | Depoxetine (DPX) 30 to 60 mg | Depoxetine (DPX) 30 to 60 to 30 mg |
|---|---|---|---|
| NauseaGastrointestinal disorders | 14/144 | 18/124 | 6/13 |
| DizzinessNervous system disorders | 13/144 | 13/124 | 6/13 |
| HeadacheNervous system disorders | 13/144 | 12/124 | 1/13 |
| VertigoEar and labyrinth disorders | 0/144 | 0/124 | 1/13 |
| DiarrhoeaGastrointestinal disorders | 0/144 | 4/124 | 1/13 |
| Feeling AbnormalGeneral disorders | 1/144 | 0/124 | 1/13 |
| Libido DecreasedPsychiatric disorders | 1/144 | 1/124 | 1/13 |
| SomnolenceNervous system disorders | 5/144 | 4/124 | 0/13 |
| Dry MouthGastrointestinal disorders | 3/144 | 4/124 | 0/13 |
| PalpitationsCardiac disorders | 4/144 | 3/124 | 0/13 |
| Age, Categorical(Participants) | Dapoxetine 30 mg Only | Dapoxetine 30 to 60 mg | Dapoxetine 30 to 60 to 30 mg | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 142 | 121 | 13 | 276 |
| >=65 years | 2 | 3 | 0 | 5 |
| Age, Continuous(years) | Dapoxetine 30 mg Only | Dapoxetine 30 to 60 mg | Dapoxetine 30 to 60 to 30 mg | Total |
|---|---|---|---|---|
| Mean | 45.5 ± 10.43 | 46.9 ± 10.47 | 41.1 ± 7.77 | 45.9 ± 10.39 |
| Sex: Female, Male(Participants) | Dapoxetine 30 mg Only | Dapoxetine 30 to 60 mg | Dapoxetine 30 to 60 to 30 mg | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 144 | 124 | 13 | 281 |
| Baseline BMI(kg/cm^2) | Dapoxetine 30 mg Only | Dapoxetine 30 to 60 mg | Dapoxetine 30 to 60 to 30 mg | Total |
|---|---|---|---|---|
| Mean | 24.7 ± 2.79 | 25.3 ± 3.20 | 23.9 ± 2.78 | 24.9 ± 2.99 |
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dapoxetine
Janssen Research & Development, LLC →