Premature Ejaculation Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | January 2020 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 19 Years to 65 Years |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Urology, Pusan National University Hospital | Busan |
Lead Sponsor | Collaborator |
---|---|
Pusan National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
1 month after initiating therapy | Yes |
Primary | 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. |
3 months after initiating therapy | Yes |
Primary | 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. |
6 months after initiating therapy | Yes |
Primary | 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. |
12 months after initiating therapy | Yes |
Primary | 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. |
24 months after initiating therapy | Yes |
Secondary | 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. |
1 month after initiating therapy | Yes |
Secondary | 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. |
3 months after initiating therapy | Yes |
Secondary | 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. |
6 months after initiating therapy | Yes |
Secondary | 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. |
12 months after initiating therapy | Yes |
Secondary | 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. |
24 months after initiating therapy | Yes |
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