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| ID | Type | Description | Link |
|---|---|---|---|
| R096769PRE3009 | Other Identifier | Johnson & Johnson Pte Ltd | |
| PASSION | Other Identifier | Johnson & Johnson Pte Ltd |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapoxetine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapoxetine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malvern | Australia | |||||
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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]).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapoxetine 30 mg Only | Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. |
| FG001 | Dapoxetine 30 to 60 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Week 12 |
| St Leonards |
| Australia |
| Sydney | Australia |
| Busan | South Korea |
| Daegu | South Korea |
| Gwangju | South Korea |
| Incheon | South Korea |
| Jeonju | South Korea |
| Jinju | South Korea |
| Seoul | South Korea |
| Wŏnju | South Korea |
| Bangkok | Thailand |
| Chiang Mai | Thailand |
Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
| FG002 | Dapoxetine 30 to 60 to 30 mg | Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapoxetine 30 mg Only | 144 of 147 patients took at least 1 dose of dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. |
| BG001 | Dapoxetine 30 to 60 mg | 124 of 125 patients took at least one dose of dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. |
| BG002 | Dapoxetine 30 to 60 to 30 mg | 13 patients took at least one dose of dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Baseline BMI | Mean | Standard Deviation | kg/cm^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Patients | Week 12 |
|
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| Secondary | 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. | 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. | Posted | Number | Patients | Baseline and Week 12 |
|
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| Secondary | 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. | 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. | Posted | Number | Patients | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Patients | Baseline and Week 12 |
| ||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Patients | Baseline and Week 12 |
| ||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Patients | Week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Number | Patients | Week 12 |
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| 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) | 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. | 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. | Posted | Number | Patients | Week 12 |
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| 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]) | 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. | 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. | Posted | Number | Patients | Week 12 |
|
Adverse events were reported for the duration of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Depoxetine (DPX) 30 mg Only | Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. | 2 | 144 | 62 | 144 | ||
| EG001 | Depoxetine (DPX) 30 to 60 mg | Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. | 0 | 124 | 57 | 124 | ||
| EG002 | Depoxetine (DPX) 30 to 60 to 30 mg | Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. | 0 | 13 | 12 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Bones Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Feeling Abnormal | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Local Swelling | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sensation of Foreign Body | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chronic Sinusitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ear Infection Fungal | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Latent Syphilis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood Bilirubin Increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
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| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Burning Sensation | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Mental Impairment | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Dissociation | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Libido Decreased | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Bronchial Hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Skin Wrinkling | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
"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.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director CDTL, RA CVM Urology | Janssen Research & Development, LLC | 1 908 704-4648 |
| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| D061686 | Premature Ejaculation |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D000097910 | Ejaculatory Dysfunction |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C080598 | dapoxetine |
Not provided
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Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Participants |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| OG002 |
| Dapoxetine 30 to 60 to 30 mg |
Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks. |
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