<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/NCT04424108</url>
  </required_header>
  <id_info>
    <org_study_id>2009/54</org_study_id>
    <nct_id>NCT04424108</nct_id>
  </id_info>
  <brief_title>Hormone Therapy on Serum Ischemia Modified Albumin in Menopausal Women</brief_title>
  <official_title>The Effect of Hormone Therapy on Serum Ischemia Modified Albumin Levels in Surgical Menopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karadeniz Technical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has&#xD;
      been considered as a 'protective factor'. However, the risk of cardiovascular disease in&#xD;
      women increases rapidly after menopause and the declining levels of endogenous estrogen is&#xD;
      thought to be the causative factor. Furthermore, Postmenopausal hormone therapy (HT)&#xD;
      decreases the severity and intensity of menopausal symptoms and improves women's quality of&#xD;
      life. Until the last 10 years, based on the results of observational studies, postmenopausal&#xD;
      HT may protect women against cardiovascular events and decrease the risk of coronary artery&#xD;
      disease by 35-50%. However, recent randomized primary and secondary prevention trials did not&#xD;
      support the cardioprotective effect of HT.&#xD;
&#xD;
      The aim of this study is to assess the effect of hormone therapy on serum ischemia modified&#xD;
      albumin (IMA) levels. Thirty surgical menopausal women who admitted to Karadeniz Technical&#xD;
      University, Faculty of Medicine, Department of Obstetrics and Gynecology during 1-year period&#xD;
      and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were&#xD;
      enrolled for this prospective study. The serum İMA levels were recorded before and after (3&#xD;
      months, 6 months, 12 months later) hormone treatment (2 mg Estradiol Hemihidrat).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2009</start_date>
  <completion_date type="Actual">May 20, 2010</completion_date>
  <primary_completion_date type="Actual">May 1, 2010</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Measuring serum ischemia-modified albumin (IMA) level</measure>
    <time_frame>12 months</time_frame>
    <description>After collecting all blood, serums were re-dissolved, and serum IMA levels were checked. IMA level was evaluated by the rapid colorimetric method developed by Barr-Or as an absorbance unit. For IMA, the results were recorded in the spectrophotometer at appropriate wavelengths, and the results were recorded as absorbance units.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hormone therapy usage</measure>
    <time_frame>12 months</time_frame>
    <description>Estradiol hemihydrate containing preparation 12 boxes in all patients given 1 tablet per day (2 mg / day) was prescribed as. Patients were recommended to reapply at the 3rd, 6th, and 12th months of treatment following drug use.</description>
  </primary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Hormone Therapy Induced Morphologic Change</condition>
  <condition>Surgical Menopause</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Within 10 months of the study period, estradiol hemihydrate for all patients who underwent&#xD;
        TAH + BSO for gynecology and obstetrics in our clinic and evaluated with the diagnosis of&#xD;
        surgical menopause in the postoperative period (6th week) was prescribed. These cases were&#xD;
        evaluated in terms of inclusion and exclusion criteria after they were determined to be&#xD;
        volunteers to participate in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  accepting consent to participate in the trial and signing the form&#xD;
&#xD;
          -  Surgical menopausal women aged 45-55 (having TAH + BSO for benign reasons)&#xD;
&#xD;
          -  Presence of vasomotor or menopausal symptoms (moderate to severe);&#xD;
&#xD;
          -  no systemic disease or infectious disease in the past 2 weeks&#xD;
&#xD;
          -  Not taking any other hormone therapy or medication until postoperative 6th week;&#xD;
&#xD;
          -  no contraindications for hormone therapy in routine menopause evaluation;&#xD;
&#xD;
          -  Willingness to take hormone therapy&#xD;
&#xD;
          -  No smoking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any systemic disease presence&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Contraindications for hormone therapy&#xD;
&#xD;
          -  Failure to follow-up&#xD;
&#xD;
          -  Inability to complete three months of hormone therapy&#xD;
&#xD;
          -  quitting hormone therapy for other medical reasons during hormone therapy&#xD;
&#xD;
          -  Cases reported as preinvasive and invasive genital tumors as a result of TAH + BSO&#xD;
&#xD;
          -  Cases reported as suspicious findings in the mammography report&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The treatment of menopause and hormone happens only in female sex.</gender_description>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
    <investigator_full_name>Suleyman Guven</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>IMA</keyword>
  <keyword>menopause</keyword>
  <keyword>hormone therapy</keyword>
  <keyword>cardiovascular risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemia</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/NCT04424108
org study id: 2009/54
nct id: NCT04424108
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Women suffer from cardiovascular diseases 10 years later than men, therefore female sex has
      been considered as a 'protective factor'. However, the risk of cardiovascular disease in
      women increases rapidly after menopause and the declining levels of endogenous estrogen is
      thought to be the causative factor. Furthermore, Postmenopausal hormone therapy (HT)
      decreases the severity and intensity of menopausal symptoms and improves women's quality of
      life. Until the last 10 years, based on the results of observational studies, postmenopausal
      HT may protect women against cardiovascular events and decrease the risk of coronary artery
      disease by 35-50%. However, recent randomized primary and secondary prevention trials did not
      support the cardioprotective effect of HT.

      The aim of this study is to assess the effect of hormone therapy on serum ischemia modified
      albumin (IMA) levels. Thirty surgical menopausal women who admitted to Karadeniz Technical
      University, Faculty of Medicine, Department of Obstetrics and Gynecology during 1-year period
      and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms were
      enrolled for this prospective study. The serum İMA levels were recorded before and after (3
      months, 6 months, 12 months later) hormone treatment (2 mg Estradiol Hemihidrat).
observational model: Cohort
time perspective: Prospective
measure: Measuring serum ischemia-modified albumin (IMA) level
time frame: 12 months
description: After collecting all blood, serums were re-dissolved, and serum IMA levels were checked. IMA level was evaluated by the rapid colorimetric method developed by Barr-Or as an absorbance unit. For IMA, the results were recorded in the spectrophotometer at appropriate wavelengths, and the results were recorded as absorbance units.
measure: Hormone therapy usage
time frame: 12 months
description: Estradiol hemihydrate containing preparation 12 boxes in all patients given 1 tablet per day (2 mg / day) was prescribed as. Patients were recommended to reapply at the 3rd, 6th, and 12th months of treatment following drug use.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: The treatment of menopause and hormone happens only in female sex.
minimum age: 45 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: Suleyman Guven
investigator title: professor
mesh term: Ischemia