<?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>IRCT20221101056361N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-08</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Metformin and Megestrol in treatment of Endometrial hyperplasia</public_title>
      <acronym></acronym>
      <scientific_title>Comparative Effect of Using Megestrol Alone and its Combination with Metformin in the Treatment of Endometrial Hyperplasia without Atypia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67428</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher assigns a number to the patients using the random allocation rule method and then puts the cards on which the patient's number is written in an envelope in a shuffle. In this method, according to the sample volume, two colors of cards (red and blue or A and B stickers) are poured into the envelope with the same number equal to the total volume of the sample. Then the eligible people entered into the study will randomly take out one of the cards from the envelope and according to the definition of the researcher, if they take the red or A card, they will enter the intervention group, and if they take the blue or B card, they will enter the control group, Blinding description: The method of blinding is that the patients of the intervention and control groups are unaware of the type of drug being used, and metformin and placebo drugs will be prepared in the form of tablets with the same shape and size. Considering the type of study that is one-sided blind, after randomization And entering the groups, patients in the control group will be given megestrol and placebo, and the patients in the intervention group will be given metformin and megestrol.</study_design>
      <phase>3</phase>
      <hc_freetext>Endometrial hyperplasia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 30 people with endometrial hyperplasia will use 40 mg megestrol and placebo from Ectororco for 14 days per month (14 days after the start of period) for 3 months. Intervention 2: Intervention group: 30 people with endometrial hyperplasia who use 1000 mg of metformin for 14 days per month for 3 months in addition to 40 mg of megestrol.</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:
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy are published

When:
The access period will start 6 months after the results are published

To whom:
Our data is only available to researchers working in scientific and academic institutions

Conditions:
If there are conditions, all our data will be shared except personal information of people. The use of our data is only allowed for similar research by other researchers. All those who work in scientific and academic centers and decide do similar research can access our data.

Where to obtain:
In order to receive information, all eligible people can collect data by referring to the person responsible for the project.
E-mail:paridokht.nourian@gmail.com ,09132326474

How to obtain:
To receive information after sending the request, the requests will be reviewed within 10 days, and if the conditions are met, it will be sent to the provided email within 30 days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Paridokht  Nourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Street, Kashani Avenue,Hajar Hospital</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816754633</zip>
        <telephone>0098383220016</telephone>
        <email>Paridokht.Nourian @Gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Setare Fatehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar Street,Kashani Ave,Hajar Hospital</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816754633</zip>
        <telephone>0098383220016</telephone>
        <email>Fatehi.s@Skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Endometrial Hyperplasia without Hyperplasia
No contraindication for the use of Metformin
Hb&gt;10
GFR&gt;30
25&lt; BMI
18-75 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Use of Metformin in the previous 6 months
Liver disease
Malabsorption
Pregnancy
Insulin injection
Kidney disease
Alcohol consumption</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N85.01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign endometrial hyperplasia</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: 30 people with endometrial hyperplasia will use 40 mg megestrol and placebo from Ectororco for 14 days per month (14 days after the start of period) for 3 months</i_keyword>
      <i_keyword>Intervention group: 30 people with endometrial hyperplasia who use 1000 mg of metformin for 14 days per month for 3 months in addition to 40 mg of megestrol</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people with EndometrIal Hyperplasia. Timepoint: The Biginning of study and three monthes later. Method of measurement: with Curettage OF endometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-09</approval_date>
        <contact_name>Ethics committee of Shahrekord  Univercity of Medical Sciences</contact_name>
        <contact_address>Parastar Street,Kashani Ave Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
