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Trial record 2 of 23 for:    priligy

Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation

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ClinicalTrials.gov Identifier: NCT03018743
Recruitment Status : Not yet recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Hyun Jun Park, Pusan National University Hospital

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.


Condition or disease Intervention/treatment
Premature Ejaculation Drug: Dapoxetine

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: a 2-year Prospective Observational Study
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Group/Cohort Intervention/treatment
dapoxetine treatment group
Consecutive patients who seek medical treatment for PE will be enrolled in the study.
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.
Other Name: Priligy




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. Discontinuation rate 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.

    If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.


  5. Discontinuation rate 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.

    If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.




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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male patients who seek medical treatment for PE will be enrolled in the study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018743


Contacts
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Contact: Hyun Jun Park 1092745311 joon501@naver.com

Locations
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Korea, Republic of
Department of Urology, Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Sponsors and Collaborators
Pusan National University Hospital

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Responsible Party: Hyun Jun Park, Associate Professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT03018743     History of Changes
Other Study ID Numbers: PNU-Dapoxetine
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders