The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy

• Sponsor: Johnson & Johnson Pte Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01063881
• Collaborator: (none)
• Enrollment: 285
• Locations: 12
• Arm: 1
• Duration (Months): 13
• Patients Per Site: 23.8
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction, Physiological	Drug: Dapoxetine	Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 285 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment [Week 12]

   The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients who described improvement with their PE of at least "slightly better" after 12 weeks of treatment with dapoxetine are provided in the table below.

Secondary Outcome Measures

1. The Patient's Level of Control Over Ejaculation [Baseline and Week 12]

   The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of control over intercourse on a 5-point scale. Patients were asked: "Over the past month, was your level of control over ejaculation Very poor, Poor, Fair, Good, or Very Good?" The number of patients who rated their level of control over ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.

2. The Patient's Level of Satisfaction With Intercourse [Baseline and Week 12]

   The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of satisfaction with intercourse on a 5-point scale. Patients were asked: "Over the past month, was your satisfaction with sexual intercourse Very poor, Poor, Fair, Good, or Very Good?" The number of patients who rated their level of satisfaction with control over ejaculation at before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.

3. The Patient's Level of Personal Distress Related to the Speed of Ejaculation [Baseline and Week 12]

   The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of distress related to the speed of ejaculation. Patient's were asked: "Over the past month, how distressed were you by how fast you ejaculated during sexual intercourse? Not at all, A little bit, Moderately, Quite a bit, Extremely." The number of patients who rated their level of personal distress related to the speed of ejaculation before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.

4. The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation [Baseline and Week 12]

   The Premature Ejaculation Profile (PEP), a patient-reported outcome measure was used to rate the patient's level of interpersonal difficulty related to the speed of ejaculation. Patient's were asked: "Over the past month, to what extent did how fast you/your partner ejaculated during sexual intercourse cause difficulty in your relationship with your partner? Not at all, A little bit, Moderately, Quite a bit, or Extremely?" The number of patients who rated their level of interpersonal difficulty before treatment and after 12 weeks of treatment with dapoxetine are provided in the table below.

5. Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine [Week 12]

   The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients reporting improvement in their PE by category of the CGIC scale after 12 weeks of treatment with dapoxetine are provided in the table below.

6. The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage) [Week 12]

   The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a slightly better response to treatment by the dose of dapoxetine they received in the study. This was a single-arm, open-label, non-randomized study in which "subgroup by dosage" was categorized based on dose-titration patterns observed during the course of the treatment period.

7. The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type) [Week 12]

   The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a "slightly better" response to treatment when grouped by type of PE disease (patients with life-long PE and patients with acquired PE). This was a single-arm, open-label, non-randomized study where patients were categorized based their PE disease after enrollment in the study.

8. The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT]) [Week 12]

   The "Clinical Global Impression of Change" (CGIC) was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. The data provided below represent the number of patients who reported at least a "slightly better" response to treatment when grouped by intravaginal ejaculation latency time (patients with an IELT of < 1 minute and patients with an IELT of > 1 minute). This was a single-arm, open-label, non-randomized study where patients were categorized based on IELT after enrollment in the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants must be heterosexual males and in a stable monogamous, sexual relationship with a female partner for at least 6 months

• must score =11 in the Premature Ejaculation Diagnostic Tool (PEDT)

• Must have a self-estimated intravaginal ejaculatory latency time (IELT) of = 2 minutes

• Must have an International Index of Erectile Dysfunction (IIEF) score a total of > or = to 21 in 6 questions from the IIEF used to assess for the absence of moderate to severe erectile dysfunction (ED)

• Premature ejaculation is not exclusively due to the direct effects of a substance (e.g., withdrawal from opioids)

• Must be in good general health with no clinically significant abnormalities as determined by medical history, physical examination, and clinical lab results

• Must have a blood pressure =180 mmHg systolic and =100 mmHg diastolic at screening and at the baseline visit

• Patient's partner must not be pregnant at screening as pregnancy might affect sexual activity

• Participants and partners must agree to attempt sexual intercourse at least 2 times (with a minimum of 24 hours between each event) during the 2-week baseline period and at least 4 times per month during the remainder of the study.

Exclusion Criteria:

• History of or current major psychiatric disorder such as mood disorder, anxiety disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder

• History of alcohol abuse and dependence, non-alcohol psychoactive substance use disorder (except for caffeine or nicotine/tobacco)

• Suspected history of illicit or recreational drug use

• Known history of moderate to severe renal impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Malvern		Australia
2		St Leonards		Australia
3		Sydney		Australia
4		Busan		Korea, Republic of
5		Daegu		Korea, Republic of
6		Gwangju		Korea, Republic of
7		Incheon		Korea, Republic of
8		Jeonju-Si		Korea, Republic of
9		Jinju-Si		Korea, Republic of
10		Seoul		Korea, Republic of
11		Bangkok		Thailand
12		Chiang Mai		Thailand

Sponsors and Collaborators

• Johnson & Johnson Pte Ltd

Investigators

• Study Director: Johnson & Johnson Pte. Ltd. Clinical Trial, Johnson & Johnson Pte Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Pte Ltd
• ClinicalTrials.gov Identifier: NCT01063881
• Other Study ID Numbers: CR016561; R096769PRE3009; PASSION
• First Posted: Feb 5, 2010
• Last Update Posted: Feb 4, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by Johnson & Johnson Pte Ltd: Sexual Dysfunction, physiological; R096769; Dapoxetine; Phase 3b; Premature Ejaculation
• Additional relevant MeSH terms: Premature Birth; Premature Ejaculation; Sexual Dysfunction, Physiological

Study Results

Participant Flow

Recruitment Details	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]).

Arm/Group Title	Dapoxetine 30 mg Only	Dapoxetine 30 to 60 mg	Dapoxetine 30 to 60 to 30 mg
Arm/Group Description	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.	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.	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.
Period Title: Overall Study
STARTED	147	125	13
COMPLETED	92	114	12
NOT COMPLETED	55	11	1

Baseline Characteristics

Arm/Group Title	Dapoxetine 30 mg Only	Dapoxetine 30 to 60 mg	Dapoxetine 30 to 60 to 30 mg	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	144	124	13	281
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	142 98.6%	121 97.6%	13 100%	276 98.2%
>=65 years	2 1.4%	3 2.4%	0 0%	5 1.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.5 (10.43)	46.9 (10.47)	41.1 (7.77)	45.9 (10.39)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	144 100%	124 100%	13 100%	281 100%
Baseline BMI (kg/cm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/cm^2]	24.7 (2.79)	25.3 (3.20)	23.9 (2.78)	24.9 (2.99)

Outcome Measures

1. Primary Outcome

Title	The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine (Week 12)
Arm/Group Description	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.
Measure Participants	257
Number [Patients]	228

2. Secondary Outcome

Title	The Patient's Level of Control Over Ejaculation
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine (Baseline)	Dapoxetine (Week 12)
Arm/Group Description	Baseline measures were taken before administration of treatment.	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.
Measure Participants	274	278
Very poor	120	22
Poor	132	57
Fair	20	77
Good	2	101
Very good	0	21

3. Secondary Outcome

Title	The Patient's Level of Satisfaction With Intercourse
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine (Baseline)	Dapoxetine (Week 12)
Arm/Group Description	Baseline measures were taken before administration of treatment.	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.
Measure Participants	274	278
Very poor	63	14
Poor	152	40
Fair	53	89
Good	6	105
Very good	0	30

4. Secondary Outcome

Title	The Patient's Level of Personal Distress Related to the Speed of Ejaculation
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine (Baseline)	Dapoxetine (Week 12)
Arm/Group Description	Baseline measures were taken before administration of treatment.	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.
Measure Participants	274	278
Not at all	2	66
A little bit	32	89
Moderately	32	66
Quite a bit	140	40
Extremely	68	17

5. Secondary Outcome

Title	The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine (Baseline)	Dapoxetine (Week 12)
Arm/Group Description	Baseline measures were taken before administration of treatment.	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.
Measure Participants	274	278
Not at all	12	87
A little bit	40	82
Moderately	78	65
Quite a bit	113	37
Extremely	31	7

6. Secondary Outcome

Title	Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine (Week 12)
Arm/Group Description	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.
Measure Participants	257
Much worse	0
Worse	0
Slightly worse	4
No change	25
Slightly better	94
Better	101
Much better	33

7. Secondary Outcome

Title	The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage)
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine 30 mg Only	Dapoxetine 30 to 60 mg	Dapoxetine 30 to 60 to 30 mg
Arm/Group Description	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.	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.	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.
Measure Participants	141	124	13
Number [Patients]	109	107	12

8. Secondary Outcome

Title	The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type)
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine (Patients With Life-long PE, Week 12)	Dapoxetine (Patients With Acquired PE, Week 12)
Arm/Group Description	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.	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.
Measure Participants	115	163
Number [Patients]	95	133

9. Secondary Outcome

Title	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])
Description	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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Dapoxetine (Patients With IELT <1 Minute, Week 12)	Dapoxetine (Patients With IELT >1 Minute, Week 12)
Arm/Group Description	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.	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.
Measure Participants	138	140
Number [Patients]	110	118

Adverse Events

Time Frame	Adverse events were reported for the duration of the study.
Arm/Group Title	Depoxetine (DPX) 30 mg Only		Depoxetine (DPX) 30 to 60 mg		Depoxetine (DPX) 30 to 60 to 30 mg
Arm/Group Description	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.		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.		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.
All Cause Mortality
	Depoxetine (DPX) 30 mg Only		Depoxetine (DPX) 30 to 60 mg		Depoxetine (DPX) 30 to 60 to 30 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Depoxetine (DPX) 30 mg Only		Depoxetine (DPX) 30 to 60 mg		Depoxetine (DPX) 30 to 60 to 30 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/144 (1.4%)		0/124 (0%)		0/13 (0%)
Injury, poisoning and procedural complications
Facial Bones Fracture	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Road Traffic Accident	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Nervous system disorders
Dizziness	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Depoxetine (DPX) 30 mg Only		Depoxetine (DPX) 30 to 60 mg		Depoxetine (DPX) 30 to 60 to 30 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	62/144 (43.1%)		57/124 (46%)		12/13 (92.3%)
Cardiac disorders
Atrial Fibrillation	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Palpitations	4/144 (2.8%)		3/124 (2.4%)		0/13 (0%)
Ear and labyrinth disorders
Vertigo	0/144 (0%)		0/124 (0%)		1/13 (7.7%)
Eye disorders
Blepharitis	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Conjunctivitis	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Dry Eye	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Gastrointestinal disorders
Abdominal Discomfort	0/144 (0%)		3/124 (2.4%)		0/13 (0%)
Abdominal Distension	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Abdominal Pain	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Diarrhoea	0/144 (0%)		4/124 (3.2%)		1/13 (7.7%)
Dry Mouth	3/144 (2.1%)		4/124 (3.2%)		0/13 (0%)
Gastrointestinal Disorder	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Nausea	14/144 (9.7%)		18/124 (14.5%)		6/13 (46.2%)
Vomiting	2/144 (1.4%)		0/124 (0%)		0/13 (0%)
General disorders
Asthenia	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Chest Discomfort	1/144 (0.7%)		1/124 (0.8%)		0/13 (0%)
Chest Pain	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Fatigue	2/144 (1.4%)		3/124 (2.4%)		0/13 (0%)
Feeling Abnormal	1/144 (0.7%)		0/124 (0%)		1/13 (7.7%)
Local Swelling	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Sensation of Foreign Body	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Thirst	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Infections and infestations
Bronchitis	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Chronic Sinusitis	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Ear Infection Fungal	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Herpes Zoster	1/144 (0.7%)		1/124 (0.8%)		0/13 (0%)
Influenza	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Latent Syphilis	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Nasopharyngitis	1/144 (0.7%)		1/124 (0.8%)		0/13 (0%)
Otitis Media	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Upper Respiratory Tract Infection	0/144 (0%)		3/124 (2.4%)		0/13 (0%)
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Upper Limb Fracture	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Investigations
Aspartate Aminotransferase Increased	3/144 (2.1%)		0/124 (0%)		0/13 (0%)
Blood Bilirubin Increased	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Blood Pressure Increased	1/144 (0.7%)		1/124 (0.8%)		0/13 (0%)
Gamma-Glutamyltransferase Increased	1/144 (0.7%)		1/124 (0.8%)		0/13 (0%)
Metabolism and nutrition disorders
Hypokalaemia	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Musculoskeletal and connective tissue disorders
Back Pain	2/144 (1.4%)		1/124 (0.8%)		0/13 (0%)
Nervous system disorders
Akathisia	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Burning Sensation	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Dizziness	13/144 (9%)		13/124 (10.5%)		6/13 (46.2%)
Headache	13/144 (9%)		12/124 (9.7%)		1/13 (7.7%)
Mental Impairment	1/144 (0.7%)		1/124 (0.8%)		0/13 (0%)
Paraesthesia	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Somnolence	5/144 (3.5%)		4/124 (3.2%)		0/13 (0%)
Psychiatric disorders
Anxiety	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Dissociation	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Insomnia	2/144 (1.4%)		1/124 (0.8%)		0/13 (0%)
Libido Decreased	1/144 (0.7%)		1/124 (0.8%)		1/13 (7.7%)
Renal and urinary disorders
Proteinuria	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Reproductive system and breast disorders
Erectile Dysfunction	2/144 (1.4%)		0/124 (0%)		0/13 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity	0/144 (0%)		1/124 (0.8%)		0/13 (0%)
Oropharyngeal Pain	0/144 (0%)		2/124 (1.6%)		0/13 (0%)
Rhinitis Allergic	0/144 (0%)		2/124 (1.6%)		0/13 (0%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Rash Papular	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Skin Wrinkling	1/144 (0.7%)		0/124 (0%)		0/13 (0%)
Vascular disorders
Flushing	1/144 (0.7%)		1/124 (0.8%)		0/13 (0%)
Hot Flush	3/144 (2.1%)		1/124 (0.8%)		0/13 (0%)

Limitations/Caveats

"Subgroup by dosage" was categorized based on dose-titration patterns observed during the course of the treatment period. Patients were not randomized to treatment by dosage group, disease type, or Intravaginal Ejaculation Latency Time.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.