<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/NCT03037944</url>
  </required_header>
  <id_info>
    <org_study_id>ASAD0316</org_study_id>
    <nct_id>NCT03037944</nct_id>
  </id_info>
  <brief_title>Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri</brief_title>
  <acronym>LNG-IUDvsCOCs</acronym>
  <official_title>Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare the efficacy of LNG - IUD (Levonorgestrel releasing intrauterine&#xD;
      device) Versus Low dose COCs (combined oral contraceptive pills) on management of heavy&#xD;
      menstrual bleeding and Dysmenorrhea caused by Adenomyosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Levonorgestrel releasing intrauterine device will be MetraPlant-E, which is used in this&#xD;
      study in group A, is a modified Levonorgestrel -releasing intrauterine system from the old&#xD;
      IUD - Intrauterine Device &quot;Metraplant&quot;, MetraPlant-E design has a T-shaped frame containing&#xD;
      Levonorgestrel and Ethylene Vinyl Acetate as well as Barium Sulphate to make it radio-opaque,&#xD;
      All the &quot;T&quot; frame, the bulb of 20 mm length and sleeves contain: Ethylene Vinyl Acetate,&#xD;
      Levonorgestrel and Barium Sulphate, which ensures more exposure of the endometrial surface to&#xD;
      the system and hence expected more endometrial suppression.&#xD;
&#xD;
      It consists of Levonorgestrel Hormone (60 mg), Ethylene Vinyl Acetate (120 mg) &amp; Barium&#xD;
      Sulphate (20 mg) Metraplant-E is designed without any coat membrane, which will help in more&#xD;
      rise in Levonorgestrel level (higher initial release). The high initial release of&#xD;
      Levonorgestrel (reached more than 28µg/24hrs in Metraplant-E in this study of in-vitro&#xD;
      release) may help in early stoppage of bleeding in patients who suffer from irregular&#xD;
      bleeding.&#xD;
&#xD;
      Women in group A will receive IUD - Intrauterine Device- during menstruation .It will be&#xD;
      inserted into uterus in similar procedure to non-hormonal IUD .Pelvic exam will be done, the&#xD;
      vagina will hold open with speculum, grasping the cervix, measuring uterine length and proper&#xD;
      insertion of IUD - Intrauterine Device by non-touch technic. Women will receive proper&#xD;
      antibiotics after insertion.&#xD;
&#xD;
      Group B will receive combined oral contraceptive pills (Yasmin) which will be Monophasic&#xD;
      pills have a constant dose of both estrogen and progestin in each of the hormonal active&#xD;
      pills throughout the entire cycle . Yasmin (ethinyl estradiol 0.03 mg/ drospirenone 3 mg)&#xD;
      tablets, it provides an oral contraceptive regimen, it will be used continuously for 6 months&#xD;
      with stoppage after 3 months for withdrawal bleeding.&#xD;
&#xD;
      Both treatment arms (Metraplant E and Yasmin) will be followed up after 3 months and 6 month&#xD;
      of patients' recruitment. Assessment of pain related symptoms will be done using visual&#xD;
      analogue scale pain score, while assessment of menstrual improvement will be done using&#xD;
      menstrual diary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2017</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of pain by pain measurement score</measure>
    <time_frame>6 Months</time_frame>
    <description>measurement of the pain score by questionnaire form filled by patients. this questionnaire is evaluated by numbers corresponding to each answer chosen by patients</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of bleeding days</measure>
    <time_frame>6 Months</time_frame>
    <description>number of bleeding days is reported by patients and compared to pre- treatment conditions to evaluate the bleeding painful process duration and whether the intervention treatment had any relieving effect</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Adenomyosis</condition>
  <arm_group>
    <arm_group_label>Group A-LNG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Levonorgestrel releasing intrauterine device - IUD- will be Metraplant-E, which is used in this study for group A, is a modified Levonorgestrel-releasing intrauterine system from the old IUD &quot;Metraplant&quot;, Metraplant-E design has a T-shaped frame containing Levonorgestrel and Ethylene Vinyl Acetate as well as Barium Sulphate to make it radio-opaque, All the &quot;T&quot; frame, the bulb of 20 mm length and sleeves contain: Ethylene Vinyl Acetate, Levonorgestrel and Barium Sulphate, ensure more exposure of the endometrial surface to the system and hence expect more endometrial suppression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B-COCs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group B will receive combined oral contraceptive pills (Yasmin) COCs which will be Monophasic pills that have a constant dose of both estrogen and progestins in each of the hormonal active pills throughout the entire cycle . Yasmin (ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets, provides an oral contraceptive regimen, it will be used continuously for 6 months with stoppage after 3 months for withdrawal bleeding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Yasmin</intervention_name>
    <description>(ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets</description>
    <arm_group_label>Group B-COCs</arm_group_label>
    <other_name>drospirenone and ethinyl estradiol tablets</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Metraplant-E</intervention_name>
    <description>Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD &quot;Metraplant&quot;, modified by Azzam 2013</description>
    <arm_group_label>Group A-LNG</arm_group_label>
    <other_name>Metraplant-E- Levonorgestrel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women patient aged 30-45 years&#xD;
&#xD;
          -  Diagnosed adenomyosis by transvaginal ultrasound or MRI or 3D ultrasound&#xD;
&#xD;
          -  Patient complains of heavy menstrual bleeding or dysmenorrhea or both&#xD;
&#xD;
          -  Living in a nearby area to make follow-up reasonably possible&#xD;
&#xD;
          -  Planning for birth spacing for at least 2 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or seeking fertility&#xD;
&#xD;
          -  Severe underlying comorbidities (hepatic, oncological)&#xD;
&#xD;
          -  Pelvic inflammatory disease&#xD;
&#xD;
          -  Other cervical or uterine pathologies&#xD;
&#xD;
          -  Deep venous thromboembolism&#xD;
&#xD;
          -  Hormonal therapy contraindications&#xD;
&#xD;
          -  Endometriosis or fibroid&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Es Abbas, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University - Maternity Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karim Mo Labib, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University - Maternity Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karim AH Labib, Assistant</last_name>
    <role>Study Chair</role>
    <affiliation>Ain Shams University - Maternity Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asmaa Ma Mohamdy, Bachelor</last_name>
    <phone>+201008340829</phone>
    <email>dr.asmaamamdoh@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Es Abbas, Lecturer</last_name>
    <phone>+201007644642</phone>
    <email>moh_3smat@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ain Shams University - Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Asmaa MA Mohamdy, Bachelors</last_name>
      <phone>+201008340829</phone>
      <email>dr.asmaamamdoh@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Karim Ah Wahba, Asst.Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karim Mo Labib, Lecturer</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mohamed Es Abbass, Lecturer</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>Benagiano, G.; Brosens, I.; Habiba, M.</citation>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 28, 2017</last_update_submitted>
  <last_update_submitted_qc>January 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>Asmaa Mamdoh Mohamdy</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>Adenomyosis</keyword>
  <keyword>Contraceptive pills</keyword>
  <keyword>Levonorgestrel-releasing Intrauterine System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenomyosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Drospirenone</mesh_term>
    <mesh_term>Levonorgestrel</mesh_term>
    <mesh_term>Ethinyl Estradiol</mesh_term>
    <mesh_term>Drospirenone and ethinyl estradiol combination</mesh_term>
    <mesh_term>Estradiol</mesh_term>
  </intervention_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/NCT03037944
org study id: ASAD0316
nct id: NCT03037944
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study aims to compare the efficacy of LNG - IUD (Levonorgestrel releasing intrauterine
      device) Versus Low dose COCs (combined oral contraceptive pills) on management of heavy
      menstrual bleeding and Dysmenorrhea caused by Adenomyosis.
Levonorgestrel releasing intrauterine device will be MetraPlant-E, which is used in this
      study in group A, is a modified Levonorgestrel -releasing intrauterine system from the old
      IUD - Intrauterine Device "Metraplant", MetraPlant-E design has a T-shaped frame containing
      Levonorgestrel and Ethylene Vinyl Acetate as well as Barium Sulphate to make it radio-opaque,
      All the "T" frame, the bulb of 20 mm length and sleeves contain: Ethylene Vinyl Acetate,
      Levonorgestrel and Barium Sulphate, which ensures more exposure of the endometrial surface to
      the system and hence expected more endometrial suppression.

      It consists of Levonorgestrel Hormone (60 mg), Ethylene Vinyl Acetate (120 mg) & Barium
      Sulphate (20 mg) Metraplant-E is designed without any coat membrane, which will help in more
      rise in Levonorgestrel level (higher initial release). The high initial release of
      Levonorgestrel (reached more than 28µg/24hrs in Metraplant-E in this study of in-vitro
      release) may help in early stoppage of bleeding in patients who suffer from irregular
      bleeding.

      Women in group A will receive IUD - Intrauterine Device- during menstruation .It will be
      inserted into uterus in similar procedure to non-hormonal IUD .Pelvic exam will be done, the
      vagina will hold open with speculum, grasping the cervix, measuring uterine length and proper
      insertion of IUD - Intrauterine Device by non-touch technic. Women will receive proper
      antibiotics after insertion.

      Group B will receive combined oral contraceptive pills (Yasmin) which will be Monophasic
      pills have a constant dose of both estrogen and progestin in each of the hormonal active
      pills throughout the entire cycle . Yasmin (ethinyl estradiol 0.03 mg/ drospirenone 3 mg)
      tablets, it provides an oral contraceptive regimen, it will be used continuously for 6 months
      with stoppage after 3 months for withdrawal bleeding.

      Both treatment arms (Metraplant E and Yasmin) will be followed up after 3 months and 6 month
      of patients' recruitment. Assessment of pain related symptoms will be done using visual
      analogue scale pain score, while assessment of menstrual improvement will be done using
      menstrual diary.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Measurement of pain by pain measurement score
time frame: 6 Months
description: measurement of the pain score by questionnaire form filled by patients. this questionnaire is evaluated by numbers corresponding to each answer chosen by patients
measure: Number of bleeding days
time frame: 6 Months
description: number of bleeding days is reported by patients and compared to pre- treatment conditions to evaluate the bleeding painful process duration and whether the intervention treatment had any relieving effect
arm group label: Group A-LNG
arm group type: Experimental
description: The Levonorgestrel releasing intrauterine device - IUD- will be Metraplant-E, which is used in this study for group A, is a modified Levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", Metraplant-E design has a T-shaped frame containing Levonorgestrel and Ethylene Vinyl Acetate as well as Barium Sulphate to make it radio-opaque, All the "T" frame, the bulb of 20 mm length and sleeves contain: Ethylene Vinyl Acetate, Levonorgestrel and Barium Sulphate, ensure more exposure of the endometrial surface to the system and hence expect more endometrial suppression.
arm group label: Group B-COCs
arm group type: Experimental
description: Group B will receive combined oral contraceptive pills (Yasmin) COCs which will be Monophasic pills that have a constant dose of both estrogen and progestins in each of the hormonal active pills throughout the entire cycle . Yasmin (ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets, provides an oral contraceptive regimen, it will be used continuously for 6 months with stoppage after 3 months for withdrawal bleeding.
intervention type: Drug
intervention name: Yasmin
description: (ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets
arm group label: Group B-COCs
other name: drospirenone and ethinyl estradiol tablets
intervention type: Device
intervention name: Metraplant-E
description: Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD "Metraplant", modified by Azzam 2013
arm group label: Group A-LNG
other name: Metraplant-E- Levonorgestrel
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mohamed Es Abbas, Lecturer
role: Principal Investigator
affiliation: Ain Shams University - Maternity Hospital
last name: Karim Mo Labib, Lecturer
role: Principal Investigator
affiliation: Ain Shams University - Maternity Hospital
last name: Karim AH Labib, Assistant
role: Study Chair
affiliation: Ain Shams University - Maternity Hospital
last name: Asmaa Ma Mohamdy, Bachelor
phone: +201008340829
email: dr.asmaamamdoh@gmail.com
last name: Mohamed Es Abbas, Lecturer
phone: +201007644642
email: moh_3smat@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Egypt
citation: Benagiano, G.; Brosens, I.; Habiba, M.
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: Asmaa Mamdoh Mohamdy
investigator title: Researcher
mesh term: Adenomyosis
mesh term: Drospirenone
mesh term: Levonorgestrel
mesh term: Ethinyl Estradiol
mesh term: Drospirenone and ethinyl estradiol combination
mesh term: Estradiol
sharing ipd: No