<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03018743</url>
  </required_header>
  <id_info>
    <org_study_id>PNU-Dapoxetine</org_study_id>
    <nct_id>NCT03018743</nct_id>
  </id_info>
  <brief_title>Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation</brief_title>
  <official_title>Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: a 2-year Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction.&#xD;
&#xD;
      Until now dapoxetine is the only approved medical treatment option and there is no second&#xD;
      line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of&#xD;
      the factors that lead to dropout is needed especially in a real-practice setting.&#xD;
&#xD;
      With this background, investigators are going to assesse the discontinuation rate of&#xD;
      dapoxetine treatment in patients with PE and the reasons for discontinuation in a clinical&#xD;
      setting throughout a follow-up period of 2 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Premature ejaculation (PE) has been known as one of the most common male sexual dysfunction.&#xD;
      PE can deteriorate sexual satisfaction and quality of life of the patients and their&#xD;
      partners. Recently, the International Society for Sexual Medicine (ISSM) gave a definition&#xD;
      that PE is a 'male sexual dysfunction characterized by ejaculation that always or nearly&#xD;
      always occurs prior to or within 1 min of vaginal penetration from the first sexual&#xD;
      experience (lifelong PE), or a clinically significant reduction in latency time, often to&#xD;
      about 3 min or less (acquired PE)' . Until now, several treatment modalities for PE have been&#xD;
      introduced. Psychological/behavioral; pharmacologic therapies, including selective serotonin&#xD;
      reuptake inhibitors (SSRIs), tricyclic antidepressants, tramadol, phosphodiesterase 5&#xD;
      inhibitor, alpha 1-andreoreceptor antagonists; topical anaesthetics, and even surgical&#xD;
      treatments have been used for PE in practice. Dapoxetine is the first oral pharmacological&#xD;
      agent developed for the treatment of PE and the only SSRI approved in more than 60 countries&#xD;
      for PE. The introduction of dapoxetine was accompanied with high expectation because of the&#xD;
      optimal efficacy/ safety profile showed in the phase 3 trials. However, several clinical&#xD;
      studies using depoxetine confirmed the efficacy in increasing IELT, it reveals significant&#xD;
      dropout rate likely which was shown in the treatment using off-label SSRIs. Despite high&#xD;
      efficacy and safety, discontinuation rate of dapoxetine is high compared to PDE5 inhibitors&#xD;
      in patients with erectile dysfunction (ED).&#xD;
&#xD;
      Until now dapoxetine is the only approved medical treatment option and there is no second&#xD;
      line therapy in case of no-response or refuse to dapoxetine, a comprehensive evaluation of&#xD;
      the factors that lead to dropout is needed especially in a real-practice setting. With this&#xD;
      background, investigators will assesse the discontinuation rate of dapoxetine treatment in&#xD;
      patients with PE and the reasons for discontinuation in a clinical setting throughout a&#xD;
      follow-up period of 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Discontinuation rate of dapoxetine treatment</measure>
    <time_frame>1 month after initiating therapy</time_frame>
    <description>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.&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discontinuation rate of dapoxetine treatment</measure>
    <time_frame>3 months after initiating therapy</time_frame>
    <description>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.&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discontinuation rate of dapoxetine treatment</measure>
    <time_frame>6 months after initiating therapy</time_frame>
    <description>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.&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discontinuation rate of dapoxetine treatment</measure>
    <time_frame>12 months after initiating therapy</time_frame>
    <description>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.&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discontinuation rate of dapoxetine treatment</measure>
    <time_frame>24 months after initiating therapy</time_frame>
    <description>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.&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reasons of discontinuation of dapoxetine treatment</measure>
    <time_frame>1 month after initiating therapy</time_frame>
    <description>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.&#xD;
The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons of discontinuation of dapoxetine treatment</measure>
    <time_frame>3 months after initiating therapy</time_frame>
    <description>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.&#xD;
The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons of discontinuation of dapoxetine treatment</measure>
    <time_frame>6 months after initiating therapy</time_frame>
    <description>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.&#xD;
The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons of discontinuation of dapoxetine treatment</measure>
    <time_frame>12 months after initiating therapy</time_frame>
    <description>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.&#xD;
The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons of discontinuation of dapoxetine treatment</measure>
    <time_frame>24 months after initiating therapy</time_frame>
    <description>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.&#xD;
The secondary outcome measures are the reasons of discontinuation of dapoxetine treatment (ex, high cost, low efficacy, side effects, etc)&#xD;
If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Premature Ejaculation</condition>
  <arm_group>
    <arm_group_label>dapoxetine treatment group</arm_group_label>
    <description>Consecutive patients who seek medical treatment for PE will be enrolled in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapoxetine</intervention_name>
    <description>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.</description>
    <arm_group_label>dapoxetine treatment group</arm_group_label>
    <other_name>Priligy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male patients who seek medical treatment for PE will be enrolled in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men without history of dapoxetine treatment;&#xD;
&#xD;
          -  &gt; 19 years old; and involvement in a stable,&#xD;
&#xD;
          -  monogamous relationship with a female sexual partner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  penile anatomical deformity;&#xD;
&#xD;
          -  spinal cord injury;&#xD;
&#xD;
          -  radical prostatectomy;&#xD;
&#xD;
          -  pelvic organ surgery;&#xD;
&#xD;
          -  diagnosis of another sexual disorder except ED;&#xD;
&#xD;
          -  an uncontrolled psychiatric disorder;&#xD;
&#xD;
          -  history of major hematological, renal, or hepatic abnormalities;&#xD;
&#xD;
          -  a history of alcoholism or substance abuse;&#xD;
&#xD;
          -  organic illness causing limitations in assuming SSRIs&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hyun Jun Park</last_name>
    <phone>1092745311</phone>
    <email>joon501@naver.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Urology, Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>602-739</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Hospital</investigator_affiliation>
    <investigator_full_name>Hyun Jun Park</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Premature Ejaculation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018743
org study id: PNU-Dapoxetine
nct id: NCT03018743
lead sponsor: 
has dmc: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Discontinuation rate of dapoxetine treatment
time frame: 1 month after initiating therapy
description: 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.
measure: Discontinuation rate of dapoxetine treatment
time frame: 3 months after initiating therapy
description: 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.
measure: Discontinuation rate of dapoxetine treatment
time frame: 6 months after initiating therapy
description: 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.
measure: Discontinuation rate of dapoxetine treatment
time frame: 12 months after initiating therapy
description: 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.
measure: Discontinuation rate of dapoxetine treatment
time frame: 24 months after initiating therapy
description: 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.
measure: Reasons of discontinuation of dapoxetine treatment
time frame: 1 month after initiating therapy
description: 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.
measure: Reasons of discontinuation of dapoxetine treatment
time frame: 3 months after initiating therapy
description: 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.
measure: Reasons of discontinuation of dapoxetine treatment
time frame: 6 months after initiating therapy
description: 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.
measure: Reasons of discontinuation of dapoxetine treatment
time frame: 12 months after initiating therapy
description: 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.
measure: Reasons of discontinuation of dapoxetine treatment
time frame: 24 months after initiating therapy
description: 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.
arm group label: dapoxetine treatment group
description: Consecutive patients who seek medical treatment for PE will be enrolled in the study.
intervention type: Drug
intervention name: Dapoxetine
description: 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.
arm group label: dapoxetine treatment group
other name: Priligy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hyun Jun Park
phone: 1092745311
email: joon501@naver.com
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Hospital
investigator full name: Hyun Jun Park
investigator title: Associate Professor
mesh term: Premature Birth
mesh term: Premature Ejaculation
sharing ipd: No