Trial Outcomes & Findings for The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy (NCT NCT01063881)
NCT ID: NCT01063881
Last Updated: 2024-11-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
285 participants
Primary outcome timeframe
Week 12
Results posted on
2024-11-19
Participant Flow
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 \[13 patients\]).
Participant milestones
| Measure |
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.
|
Dapoxetine 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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
147
|
125
|
13
|
|
Overall Study
COMPLETED
|
92
|
114
|
12
|
|
Overall Study
NOT COMPLETED
|
55
|
11
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Dapoxetine 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.
|
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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
13
|
7
|
1
|
|
Overall Study
Withdrawal by Subject
|
25
|
1
|
0
|
|
Overall Study
Reason for not completed not specified
|
5
|
1
|
0
|
Baseline Characteristics
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Baseline characteristics by cohort
| Measure |
Dapoxetine 30 mg Only
n=144 Participants
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.
|
Dapoxetine 30 to 60 mg
n=124 Participants
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.
|
Dapoxetine 30 to 60 to 30 mg
n=13 Participants
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.
|
Total
n=281 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
142 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
46.9 years
STANDARD_DEVIATION 10.47 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 10.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
281 Participants
n=4 Participants
|
|
Baseline BMI
|
24.7 kg/cm^2
STANDARD_DEVIATION 2.79 • n=5 Participants
|
25.3 kg/cm^2
STANDARD_DEVIATION 3.20 • n=7 Participants
|
23.9 kg/cm^2
STANDARD_DEVIATION 2.78 • n=5 Participants
|
24.9 kg/cm^2
STANDARD_DEVIATION 2.99 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=257 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
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.
|
|---|---|---|---|
|
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment
|
228 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=274 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
n=278 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
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.
|
|---|---|---|---|
|
The Patient's Level of Control Over Ejaculation
Very poor
|
120 Patients
|
22 Patients
|
—
|
|
The Patient's Level of Control Over Ejaculation
Poor
|
132 Patients
|
57 Patients
|
—
|
|
The Patient's Level of Control Over Ejaculation
Fair
|
20 Patients
|
77 Patients
|
—
|
|
The Patient's Level of Control Over Ejaculation
Good
|
2 Patients
|
101 Patients
|
—
|
|
The Patient's Level of Control Over Ejaculation
Very good
|
0 Patients
|
21 Patients
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=274 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
n=278 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
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.
|
|---|---|---|---|
|
The Patient's Level of Satisfaction With Intercourse
Very poor
|
63 Patients
|
14 Patients
|
—
|
|
The Patient's Level of Satisfaction With Intercourse
Poor
|
152 Patients
|
40 Patients
|
—
|
|
The Patient's Level of Satisfaction With Intercourse
Fair
|
53 Patients
|
89 Patients
|
—
|
|
The Patient's Level of Satisfaction With Intercourse
Good
|
6 Patients
|
105 Patients
|
—
|
|
The Patient's Level of Satisfaction With Intercourse
Very good
|
0 Patients
|
30 Patients
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=274 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
n=278 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
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.
|
|---|---|---|---|
|
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
Not at all
|
2 Patients
|
66 Patients
|
—
|
|
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
A little bit
|
32 Patients
|
89 Patients
|
—
|
|
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
Moderately
|
32 Patients
|
66 Patients
|
—
|
|
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
Quite a bit
|
140 Patients
|
40 Patients
|
—
|
|
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
Extremely
|
68 Patients
|
17 Patients
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=274 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
n=278 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
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.
|
|---|---|---|---|
|
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
Not at all
|
12 Patients
|
87 Patients
|
—
|
|
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
A little bit
|
40 Patients
|
82 Patients
|
—
|
|
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
Moderately
|
78 Patients
|
65 Patients
|
—
|
|
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
Quite a bit
|
113 Patients
|
37 Patients
|
—
|
|
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
Extremely
|
31 Patients
|
7 Patients
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=257 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
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.
|
|---|---|---|---|
|
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Much worse
|
0 Patients
|
—
|
—
|
|
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Worse
|
0 Patients
|
—
|
—
|
|
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Slightly worse
|
4 Patients
|
—
|
—
|
|
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
No change
|
25 Patients
|
—
|
—
|
|
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Slightly better
|
94 Patients
|
—
|
—
|
|
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Better
|
101 Patients
|
—
|
—
|
|
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Much better
|
33 Patients
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=141 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
n=124 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine 30 to 60 to 30 mg
n=13 Participants
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.
|
|---|---|---|---|
|
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage)
|
109 Patients
|
107 Patients
|
12 Patients
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=115 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
n=163 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
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.
|
|---|---|---|---|
|
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 Patients
|
133 Patients
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Dapoxetine (Week 12)
n=138 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
Dapoxetine (Week 12)
n=140 Participants
Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
|
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.
|
|---|---|---|---|
|
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 Patients
|
118 Patients
|
—
|
Adverse Events
Depoxetine (DPX) 30 to 60 to 30 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Depoxetine (DPX) 30 mg Only
Serious events: 2 serious events
Other events: 62 other events
Deaths: 0 deaths
Depoxetine (DPX) 30 to 60 mg
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Depoxetine (DPX) 30 to 60 to 30 mg
n=13 participants at risk
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.
|
Depoxetine (DPX) 30 mg Only
n=144 participants at risk
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.
|
Depoxetine (DPX) 30 to 60 mg
n=124 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
Other adverse events
| Measure |
Depoxetine (DPX) 30 to 60 to 30 mg
n=13 participants at risk
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.
|
Depoxetine (DPX) 30 mg Only
n=144 participants at risk
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.
|
Depoxetine (DPX) 30 to 60 mg
n=124 participants at risk
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.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
2.8%
4/144 • Adverse events were reported for the duration of the study.
|
2.4%
3/124 • Adverse events were reported for the duration of the study.
|
|
Ear and labyrinth disorders
Vertigo
|
7.7%
1/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Eye disorders
Blepharitis
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Eye disorders
Dry Eye
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
2.4%
3/124 • Adverse events were reported for the duration of the study.
|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
3.2%
4/124 • Adverse events were reported for the duration of the study.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
2.1%
3/144 • Adverse events were reported for the duration of the study.
|
3.2%
4/124 • Adverse events were reported for the duration of the study.
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Adverse events were reported for the duration of the study.
|
9.7%
14/144 • Adverse events were reported for the duration of the study.
|
14.5%
18/124 • Adverse events were reported for the duration of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
1.4%
2/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
General disorders
Asthenia
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
General disorders
Chest Discomfort
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
General disorders
Chest Pain
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
General disorders
Fatigue
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
1.4%
2/144 • Adverse events were reported for the duration of the study.
|
2.4%
3/124 • Adverse events were reported for the duration of the study.
|
|
General disorders
Feeling Abnormal
|
7.7%
1/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
General disorders
Local Swelling
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
General disorders
Sensation of Foreign Body
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
General disorders
Thirst
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Chronic Sinusitis
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Ear Infection Fungal
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Latent Syphilis
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
2.4%
3/124 • Adverse events were reported for the duration of the study.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
2.1%
3/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
1.4%
2/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Nervous system disorders
Burning Sensation
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Nervous system disorders
Dizziness
|
46.2%
6/13 • Adverse events were reported for the duration of the study.
|
9.0%
13/144 • Adverse events were reported for the duration of the study.
|
10.5%
13/124 • Adverse events were reported for the duration of the study.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Adverse events were reported for the duration of the study.
|
9.0%
13/144 • Adverse events were reported for the duration of the study.
|
9.7%
12/124 • Adverse events were reported for the duration of the study.
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
3.5%
5/144 • Adverse events were reported for the duration of the study.
|
3.2%
4/124 • Adverse events were reported for the duration of the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
1.4%
2/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Psychiatric disorders
Libido Decreased
|
7.7%
1/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
1.4%
2/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
1.6%
2/124 • Adverse events were reported for the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.00%
0/144 • Adverse events were reported for the duration of the study.
|
1.6%
2/124 • Adverse events were reported for the duration of the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Skin and subcutaneous tissue disorders
Skin Wrinkling
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.00%
0/124 • Adverse events were reported for the duration of the study.
|
|
Vascular disorders
Flushing
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
0.69%
1/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/13 • Adverse events were reported for the duration of the study.
|
2.1%
3/144 • Adverse events were reported for the duration of the study.
|
0.81%
1/124 • Adverse events were reported for the duration of the study.
|
Additional Information
Sr. Director CDTL, RA CVM Urology
Janssen Research & Development, LLC
Phone: 1 908 704-4648
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60