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Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation

NCT03018743 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2017-01-12

No results posted yet for this study

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.

Conditions

  • Premature Ejaculation

Interventions

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.

Sponsors & Collaborators

  • Pusan National University Hospital

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-01-31
Completion
2020-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03018743 on ClinicalTrials.gov