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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01063881

Enrollment

285

Registered

2010-02-05

Start date

2010-05-22

Completion date

2011-06-14

Last updated

2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Dysfunction, Physiological

Keywords

Sexual Dysfunction, physiological, R096769, Dapoxetine, Phase 3b, Premature Ejaculation

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.

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.

Interventions

DRUGDapoxetine

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.

Countries

Australia, South Korea, Thailand

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 \[13 patients\]).

Participants by arm

Arm	Count
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.	144
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.	124
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.	13
Total	281

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	12	2	0
Overall Study	Lost to Follow-up	13	7	1
Overall Study	Reason for not completed not specified	5	1	0
Overall Study	Withdrawal by Subject	25	1	0

Baseline characteristics

Characteristic	Dapoxetine 30 to 60 mg	Dapoxetine 30 to 60 to 30 mg	Dapoxetine 30 mg Only	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	3 Participants	0 Participants	2 Participants	5 Participants
Age, Categorical Between 18 and 65 years	121 Participants	13 Participants	142 Participants	276 Participants
Age, Continuous	46.9 years STANDARD_DEVIATION 10.47	41.1 years STANDARD_DEVIATION 7.77	45.5 years STANDARD_DEVIATION 10.43	45.9 years STANDARD_DEVIATION 10.39
Baseline BMI	25.3 kg/cm^2 STANDARD_DEVIATION 3.2	23.9 kg/cm^2 STANDARD_DEVIATION 2.78	24.7 kg/cm^2 STANDARD_DEVIATION 2.79	24.9 kg/cm^2 STANDARD_DEVIATION 2.99
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	124 Participants	13 Participants	144 Participants	281 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	62 / 144	57 / 124	12 / 13
serious Total, serious adverse events	2 / 144	0 / 124	0 / 13

Outcome results

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.

Time frame: Week 12