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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03018743
Other study ID # PNU-Dapoxetine
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 8, 2017
Last updated January 10, 2017
Start date January 2017
Est. completion date January 2020

Study information

Verified date January 2017
Source Pusan National University Hospital
Contact Hyun Jun Park
Phone 1092745311
Email joon501@naver.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Department of Urology, Pusan National University Hospital Busan

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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
See also
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Completed NCT01203202 - Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation Phase 2
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Completed NCT03304808 - Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0 N/A
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Recruiting NCT02571101 - A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation Phase 2
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Completed NCT02794454 - A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health N/A
Completed NCT02297152 - A New Treatment for Premature Ejaculation? N/A