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

October 24, 2024 updated by: Janssen Research & Development, LLC
The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Malvern, Australia
      • St Leonards, Australia
      • Sydney, Australia
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Daegu, Korea, Republic of
      • Gwangju-Si, Korea, Republic of
      • Incheon, Korea, Republic of
      • Jeonju-Si, Korea, Republic of
      • Jinju-Si, Korea, Republic of
      • Seoul, Korea, Republic of
      • Wonju, Korea, Republic of
  • Thailand
      • Bangkok, Thailand
      • Chiang Mai, Thailand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment
Time Frame: 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.
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Patient's Level of Control Over Ejaculation
Time Frame: 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.
Baseline and Week 12
The Patient's Level of Satisfaction With Intercourse
Time Frame: 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.
Baseline and Week 12
The Patient's Level of Personal Distress Related to the Speed of Ejaculation
Time Frame: 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.
Baseline and Week 12
The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation
Time Frame: 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.
Baseline and Week 12
Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine
Time Frame: 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.
Week 12
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage)
Time Frame: 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.
Week 12
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type)
Time Frame: 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.
Week 12
The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT])
Time Frame: 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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 22, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016561
  • R096769PRE3009 (Other Identifier: Johnson & Johnson Pte Ltd)
  • PASSION (Other Identifier: Johnson & Johnson Pte Ltd)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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