<?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>IRCT2016092429960N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-01</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the therapeutic effect of topical sildenafil gel and oral sildenafil pill in patients with erectile dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the therapeutic effect of topical sildenafil gel and oral sildenafil pill in patients with erectile dysfunction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23954</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All patients will be randomized with a blocked randomization technique. The treatment group will be assigned with Excel software and use of Rand Function. Patients will be grouped into four-person groups. Physician and patients are not informed about treatment, Blinding description: In the present study, the physician and the drug provider will not be aware of the type of treatment and the group of patients. All patients will receive tablets and gels that have the same appearance and are not aware of the treatment group. Medications with labels A and B are indicated for final analysis and return of results.</study_design>
      <phase>3</phase>
      <hc_freetext>Erectile dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Oral sildenafil pill 50 mg one hour before sexual contact for one month in intervention group. Intervention 2: Topical sildenafil gel which applied half an hour before sexual contact on penis for one month in intervention group. Intervention 3: Placebo Pill and Placebo Gel before sexual contact for one month in control group.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
all collected deidentified IPD

When:
starting 6 months after publication

To whom:
only available for people working in academic institutions

Conditions:
Data will be available for re-analysis and also for use in meta-analysis

Where to obtain:
f-sheybaeem@razi.tums.ac.ir

How to obtain:
Inform the responsible person via email and after coordination with Dr. Younes Panahi, the data will be available.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farshad Sheibani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8889 3974</telephone>
        <email>f-sheybaeem@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farshad sheibani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417653761</zip>
        <telephone>+98 21 8889 3974</telephone>
        <email>f-sheybaeem@razi.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 30 to 70 years
having erectile dysfunction</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Penile anatomic abnormalities
other sexual dysfunctions
spinal cord injuries
Acute myocardial infarction within last 6 months
Cerebrovascular accident
nitrate drug use
Peptic ulcer disease
Migrane
visual disturbances
Allergic rhinitis</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.2,N48.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>The principal problem in men is erectile dysfunction (difficulty in developing or maintaining an erection suitable for satisfactory intercourse),</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Oral sildenafil pill 50 mg one hour before sexual contact for one month in intervention group</i_keyword>
      <i_keyword>Topical sildenafil gel which applied half an hour before sexual contact on penis for one month in intervention group</i_keyword>
      <i_keyword>Placebo Pill and Placebo Gel before sexual contact for one month in control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual satisfaction of patient. Timepoint: before intervention, one month after intervention. Method of measurement: International index of erectile function questionnaire (IIEF).</prim_outcome>
      <prim_outcome>Sexual satisfaction of patient's sexual partner. Timepoint: before intervention, one month after intervention. Method of measurement: sexual partner satisfaction questionnaire.</prim_outcome>
      <prim_outcome>Dorsal penile artery PSV. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.</prim_outcome>
      <prim_outcome>Dorsal penile vein EDV. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.</prim_outcome>
      <prim_outcome>Dorsal penile artery RI. Timepoint: before intervention, two weeks after intervention. Method of measurement: Color doppler sonography of the penis.</prim_outcome>
      <prim_outcome>Erection quality. Timepoint: before intervention, one month after intervention. Method of measurement: regidity of the penis during sexual contact based on patient interview.</prim_outcome>
      <prim_outcome>Erection time. Timepoint: before intervention, one month after intervention. Method of measurement: The stability of erection before orgasm or ejaculation based on patient interview.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Complication. Timepoint: during study and one month after intervention. Method of measurement: based on patient interview.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-18</approval_date>
        <contact_name>ِEthics committe of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran University of Medical Sciences, Pour Sina alley, Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
