<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/NCT01662167</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1133-3069</org_study_id>
    <nct_id>NCT01662167</nct_id>
  </id_info>
  <brief_title>Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy</brief_title>
  <official_title>Comparison of Single and Multiple-dose Methotrexate Therapy for Ectopic Pregnancy: a Clinical Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hormozgan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hormozgan University of Medical Sciences</source>
  <brief_summary>
    <textblock>
      The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hCG level decrease</measure>
    <time_frame>4 days after administration</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Pregnancy, Ectopic</condition>
  <arm_group>
    <arm_group_label>Multiple dose mtx</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mtx</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single</intervention_name>
    <description>In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved</description>
    <arm_group_label>Single Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multipe</intervention_name>
    <description>In the multiple dose regimen, 1 mg/kg/day intramuscular methotrexate was given on days one, three, five and seven and 0.1 mg/kg/day intramuscular Citrovoram factor was administered on days two, four, six and eight until serum hCG level decreased 15% in 48 hours or four doses of methotrexate was given weekly until serum hCG level of 15 mlU/ml or less was obtained</description>
    <arm_group_label>Multiple dose mtx</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unruptured tubal EP&#xD;
&#xD;
          -  gestational mass of less than or equal to 3.5 cm in ultrasonography report&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  contraindications related to the use of MTX&#xD;
&#xD;
          -  hepatic&#xD;
&#xD;
          -  renal and active pulmonary diseases&#xD;
&#xD;
          -  peptic ulcer&#xD;
&#xD;
          -  immune deficiency status&#xD;
&#xD;
          -  alcohol abuse&#xD;
&#xD;
          -  blood dyscreasia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shariaty Hospital</name>
      <address>
        <city>Bandar Abbas</city>
        <state>Hormozgan</state>
        <zip>79761</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 9, 2012</last_update_submitted>
  <last_update_submitted_qc>August 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hormozgan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mohammad E Shahrzad, MD</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy, Ectopic</mesh_term>
    <mesh_term>Cardiac Complexes, Premature</mesh_term>
  </condition_browse>
  <!-- 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/NCT01662167
org study id: U1111-1133-3069
nct id: NCT01662167
lead sponsor: 
The aim of this study was to compare single dose Methotrexate (MTX) to multiple dose MTX.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: hCG level decrease
time frame: 4 days after administration
arm group label: Multiple dose mtx
arm group type: Experimental
description: mtx
arm group label: Single Dose
arm group type: Experimental
description: In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved
intervention type: Drug
intervention name: Single
description: In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved
arm group label: Single Dose
intervention type: Drug
intervention name: Multipe
description: In the multiple dose regimen, 1 mg/kg/day intramuscular methotrexate was given on days one, three, five and seven and 0.1 mg/kg/day intramuscular Citrovoram factor was administered on days two, four, six and eight until serum hCG level decreased 15% in 48 hours or four doses of methotrexate was given weekly until serum hCG level of 15 mlU/ml or less was obtained
arm group label: Multiple dose mtx
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Hormozgan University of Medical Sciences
investigator full name: Mohammad E Shahrzad, MD
investigator title: Dr
mesh term: Pregnancy, Ectopic
mesh term: Cardiac Complexes, Premature