Clinical Trial: Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: a 2-year Prospective Observational Study
Brief 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 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 Summary:
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
Sponsor: Pusan National University Hospital
Current 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 ]Same as current
Current Secondary Outcome:
- 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.
- 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.
- 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.
- 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.
- 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.
Original Secondary Outcome: Same as current
Information By: Pusan National University Hospital
Dates:
Date Received: January 8, 2017
Date Started: January 2017
Date Completion: January 2020
Last Updated: January 10, 2017
Last Verified: January 2017
- Reasons of discontinuation of dapoxetine treatment [ Time Frame: 1 month after initiating therapy ]
