<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20150913024006N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-02</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of adding sertraline to dapoxetine in relieving sexual problems in men</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study on the efficacy of add-on sertraline or dapoxetine to PDE-5 inhibitors (phosphodiesterase type 5) on the erectile function and intra-vaginal ejaculation latency time (IELT) among patients with concomitant erectile dysfunction and premature ejaculation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52939</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization patients in the two groups simple randomization is used. For this purpose, 50 pieces of paper with the letter A written on 25 of them and the letter B written on the other 25 pieces are poured into the box. Each patient is asked to take a sheet out of the box when entering the study. Depending on what is written on the sheet, the patient enters the first group (A) or the second group (B), Blinding description: This study is performed by two-blind method. Medications in similar packages prepared by the pharmaceutical company are provided by the researcher to patients who are unaware of the contents of the packages. The outcome of treatment is also assessed by another psychiatrist who is unaware of the type of medication the patient is receiving.</study_design>
      <phase>3</phase>
      <hc_freetext>Erectile dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: This group of patients take a 60 mg oral tablet of dapoxetine made by Exir Pharmaceutical Company one to three hours before the start of sexual activity with the maximum allowed dose for 24 hours. Intervention 2: Intervention group 2: This group takes a 50 mg Sertraline tablet made by Osweh Pharmaceutical Company twice a day for a month.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The plan belongs to a government agency and cannot be shared.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloufar kiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of psychology, Noor hospital, Ostandari street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8434193474</zip>
        <telephone>+98 31 3669 2174</telephone>
        <email>kiani1357@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mitra Molaeinejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of psychology, Noor hospital, Ostandari street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8434193474</zip>
        <telephone>+98 31 3669 2174</telephone>
        <email>M_molaei@bsrc.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Erectile dysfunction anda score above 20 in the  International index of Erectile Function
Treatment with phosphodiesterase 5 inhibitors (such as Sildenafil, Tadalafil) more than three months before the start of the study
Living  in a stable and heterosexual relationship  and intention for maintaining the relationship until the end of the study period
Possibility of sexual intercourse at least once a week</inclusion_criteria>
      <agemin>18 months</agemin>
      <agemax>80 months</agemax>
      <gender>Male</gender>
      <exclusion_criteria>ُSensitivity to Selective Serotonin Reuptake Inhibitors(SSRI) drugs
Urinary tract infections
Neurological disorders
History of pelvic surgery
Underlying diseases such as diabetes, heart disease, hypertension, thyroid disorder
Use of psychiatric drugs
Alcohol consumption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Male erectile dysfunction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: This group of patients take a 60 mg oral tablet of dapoxetine made by Exir Pharmaceutical Company one to three hours before the start of sexual activity with the maximum allowed dose for 24 hours.</i_keyword>
      <i_keyword>Intervention group 2: This group takes a 50 mg Sertraline tablet made by Osweh Pharmaceutical Company twice a day for a month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Erectile function. Timepoint: Before the intervention and 4, 8, 12 weeks after the start of the intervention. Method of measurement: Erectile Performance Index Questionnaire.</prim_outcome>
      <prim_outcome>Premature ejaculation. Timepoint: Before the intervention and 4, 8, 12 weeks after the start of the intervention. Method of measurement: The interval between the beginning of sexual intercourse and the time of ejaculation in minutes in the before the intervention and 4, 8, 12 weeks after the start of the intervention.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Premature ejaculation. Timepoint: Before the intervention and 4, 8, 12 weeks after the start of the intervention. Method of measurement: The interval between the beginning of sexual intercourse and the time of ejaculation in minutes.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-19</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Research faculty, Isfahan University of Medical Sceices, Hezarjerib street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
