Premature EjaculationNCT03018743
Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation
An observational study of Premature Ejaculation, run by Pusan National University Hospital at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 65 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Dapoxetine
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients who seek medical treatment for PE will be enrolled in the study.
Who may be able to join
- men without history of dapoxetine treatment;
- > 19 years old; and involvement in a stable,
- monogamous relationship with a female sexual partner
Who cannot join
- penile anatomical deformity;
- spinal cord injury;
- radical prostatectomy;
- pelvic organ surgery;
- diagnosis of another sexual disorder except ED;
- an uncontrolled psychiatric disorder;
Show all 9Show fewer
- history of major hematological, renal, or hepatic abnormalities;
- a history of alcoholism or substance abuse;
- organic illness causing limitations in assuming SSRIs
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Pusan National University Hospital
Busan, 602-739
About this study
Official title: 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.
Read the 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.
- Conditions
- Premature Ejaculation
- Being tested
- Dapoxetine
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapoxetineDrug
Also called Priligy
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.
| Study group | Role | What they receive |
|---|---|---|
| dapoxetine treatment group | Consecutive patients who seek medical treatment for PE will be enrolled in the study. Receives: Drug: Dapoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuation rate of dapoxetine treatment
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.
Measured: 1 month after initiating therapy
Discontinuation rate of dapoxetine treatment
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.
Measured: 3 months after initiating therapy
Discontinuation rate of dapoxetine treatment
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.
Measured: 6 months after initiating therapy
Discontinuation rate of dapoxetine treatment
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.
Measured: 12 months after initiating therapy
Discontinuation rate of dapoxetine treatment
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.
Measured: 24 months after initiating therapy
Secondary outcomes (5)
Reasons of discontinuation of dapoxetine treatment
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.
Measured: 1 month after initiating therapy
Reasons of discontinuation of dapoxetine treatment
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.
Measured: 3 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
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.
Measured: 6 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
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.
Measured: 12 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
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.
Measured: 24 months after initiating therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jun Park, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018743
- Sponsor's protocol ID
- PNU-Dapoxetine
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: a 2-year Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03018743
- Acronym / sponsor ID
- PNU-Dapoxetine
- Conditions
- Premature Ejaculation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dapoxetine treatment group | – | Drug: DapoxetineConsecutive patients who seek medical treatment for PE will be enrolled in the study. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients who seek medical treatment for PE will be enrolled in the study.
Key inclusion criteria (3 listed)
- men without history of dapoxetine treatment;
- > 19 years old; and involvement in a stable,
- monogamous relationship with a female sexual partner
Key exclusion criteria (9 listed)
- penile anatomical deformity;
- spinal cord injury;
- radical prostatectomy;
- pelvic organ surgery;
- diagnosis of another sexual disorder except ED;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapoxetineAlso: PriligyPatients 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. | Drug | dapoxetine treatment group |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
Reasons of discontinuation of dapoxetine treatment
Time frame: 1 month after initiating therapy
Reasons of discontinuation of dapoxetine treatment
Time frame: 3 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
Time frame: 6 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
Time frame: 12 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
Time frame: 24 months after initiating therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Ejaculation, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun Jun Park (1092745311, joon501@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discontinuation rate of dapoxetine treatment (time frame: 1 month after initiating therapy). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.