Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 8, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedJanuary 12, 2017
January 1, 2017
2 years
January 8, 2017
January 10, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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
Secondary Outcomes (5)
Reasons of discontinuation of dapoxetine treatment
1 month after initiating therapy
Reasons of discontinuation of dapoxetine treatment
3 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
6 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
12 months after initiating therapy
Reasons of discontinuation of dapoxetine treatment
24 months after initiating therapy
Study Arms (1)
dapoxetine treatment group
Consecutive patients who seek medical treatment for PE will be enrolled in the study.
Interventions
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.
Eligibility Criteria
Male patients who seek medical treatment for PE will be enrolled in the study.
You may qualify if:
- men without history of dapoxetine treatment;
- \> 19 years old; and involvement in a stable,
- monogamous relationship with a female sexual partner
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Urology, Pusan National University Hospital
Busan, 602-739, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 8, 2017
First Posted
January 12, 2017
Study Start
January 1, 2017
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
January 12, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share