Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation

January 10, 2017 updated by: Hyun Jun Park, Pusan National University Hospital

Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: a 2-year Prospective Observational Study

Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction.

Until now dapoxetine is the only approved medical treatment option and there is no second line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of the factors that lead to dropout is needed especially in a real-practice setting.

With this background, investigators are going to assesse the discontinuation rate of dapoxetine treatment in patients with PE and the reasons for discontinuation in a clinical setting throughout a follow-up period of 2 years.

Study Overview

Status

Status

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

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

Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction. PE can deteriorate sexual satisfaction and quality of life of the patients and their partners. Recently, the International Society for Sexual Medicine (ISSM) gave a definition that PE is a 'male sexual dysfunction characterized by ejaculation that always or nearly always occurs prior to or within 1 min of vaginal penetration from the first sexual experience (lifelong PE), or a clinically significant reduction in latency time, often to about 3 min or less (acquired PE)' . Until now, several treatment modalities for PE have been introduced. Psychological/behavioral; pharmacologic therapies, including selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, tramadol, phosphodiesterase 5 inhibitor, alpha 1-andreoreceptor antagonists; topical anaesthetics, and even surgical treatments have been used for PE in practice. Dapoxetine is the first oral pharmacological agent developed for the treatment of PE and the only SSRI approved in more than 60 countries for PE. The introduction of dapoxetine was accompanied with high expectation because of the optimal efficacy/ safety profile showed in the phase 3 trials. However, several clinical studies using depoxetine confirmed the efficacy in increasing IELT, it reveals significant dropout rate likely which was shown in the treatment using off-label SSRIs. Despite high efficacy and safety, discontinuation rate of dapoxetine is high compared to PDE5 inhibitors in patients with erectile dysfunction (ED).

Until now dapoxetine is the only approved medical treatment option and there is no second line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of the factors that lead to dropout is needed especially in a real-practice setting. With this background, investigators will assesse the discontinuation rate of dapoxetine treatment in patients with PE and the reasons for discontinuation in a clinical setting throughout a follow-up period of 2 years.

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.
Observational

Enrollment (Anticipated)

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.
200

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Department of Urology, Pusan National University Hospital

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

15 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male patients who seek medical treatment for PE will be enrolled in the study.

Description

Inclusion Criteria:

  • men without history of dapoxetine treatment;
  • > 19 years old; and involvement in a stable,
  • monogamous relationship with a female sexual partner

Exclusion Criteria:

  • penile anatomical deformity;
  • spinal cord injury;
  • radical prostatectomy;
  • pelvic organ surgery;
  • diagnosis of another sexual disorder except ED;
  • an uncontrolled psychiatric disorder;
  • history of major hematological, renal, or hepatic abnormalities;
  • a history of alcoholism or substance abuse;
  • organic illness causing limitations in assuming SSRIs

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
dapoxetine treatment group
Consecutive patients who seek medical treatment for PE will be enrolled in the study.
Drug: Dapoxetine
Patients receive dapoxetine (taken 1-3 hours before sexual intercourse) 30mg as needed. A dose escalation to 60mg will be consented after 1 month in case of low efficacy. Patients will be re-evaluated 1, 3, 6, 12, and 24 months after initiating therapy regarding the treatment status and the reasons for treatment discontinuation in the case of discontinuation. If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
Other Names:
  • Priligy

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
Discontinuation rate of dapoxetine treatment
Time Frame: 1 month after initiating therapy

Patients will be evaluated 1 month after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
1 month after initiating therapy
Discontinuation rate of dapoxetine treatment
Time Frame: 3 months after initiating therapy

Patients will be evaluated 3 months after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
3 months after initiating therapy
Discontinuation rate of dapoxetine treatment
Time Frame: 6 months after initiating therapy

Patients will be evaluated 6 months after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
6 months after initiating therapy
Discontinuation rate of dapoxetine treatment
Time Frame: 12 months after initiating therapy

Patients will be evaluated 12 months after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
12 months after initiating therapy
Discontinuation rate of dapoxetine treatment
Time Frame: 24 months after initiating therapy

Patients will be evaluated 24 months after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
24 months after initiating therapy

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
Reasons of discontinuation of dapoxetine treatment
Time Frame: 1 month after initiating therapy

Patients will be evaluated 1 month after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
1 month after initiating therapy
Reasons of discontinuation of dapoxetine treatment
Time Frame: 3 months after initiating therapy

Patients will be evaluated 3 months after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
3 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
Time Frame: 6 months after initiating therapy

Patients will be evaluated 6 months after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
6 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
Time Frame: 12 months after initiating therapy

Patients will be evaluated 12 months after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
12 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
Time Frame: 24 months after initiating therapy

Patients will be evaluated 24 months after initiating therapy regarding the treatment status (whether they treat or drop-out) for treatment discontinuation in the case of discontinuation.

The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)

If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
24 months after initiating therapy

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.
Pusan National University Hospital

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

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.
January 1, 2017

Primary Completion (Anticipated)

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.
January 1, 2019

Study Completion (Anticipated)

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.
January 1, 2020

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).
January 8, 2017

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.
January 10, 2017

First Posted (Estimate)

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.
January 12, 2017

Study Record Updates

Last Update Posted (Estimate)

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.
January 12, 2017

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.
January 10, 2017

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.
January 1, 2017

More Information

Terms related to this study

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.
  • PNU-Dapoxetine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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