<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/NCT04424173</url>
  </required_header>
  <id_info>
    <org_study_id>2007/25</org_study_id>
    <nct_id>NCT04424173</nct_id>
  </id_info>
  <brief_title>Combined Hormone Therapy, C-reactive Protein(CRP) Levels and Life Quality in Natural Menopause Women</brief_title>
  <official_title>The Effect of Low Dose Combined Hormone Therapy (Estradiol And Norethindrone Acetate) on Serum CRP Levels and Life Quality in Natural Menopause 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>
      This study aims to assess the effect of low dose combined estradiol and norethindrone acetate&#xD;
      hormone therapy on serum CRP levels and life quality in natural menopause women. 45 natural&#xD;
      menopause women who admitted to Karadeniz Technical University, Faculty of Medicine,&#xD;
      Department of Obstetrics and Gynaecology for 1 year and diagnosed as menopause and planned to&#xD;
      have hormone therapy for menopausal symptoms involved in this study. The serum CRP levels and&#xD;
      vasomotor symptoms scores graded according to Blatt-Kupperman Index and life quality scores&#xD;
      according to Menopause-Specific Quality of Life Questionnaire (MENQOL) in Turkish were&#xD;
      recorded before and after (3 months later) low dose hormone treatment (1 mg Estradiol and 0.5&#xD;
      mg Norethindrone acetate).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2007</start_date>
  <completion_date type="Actual">August 30, 2008</completion_date>
  <primary_completion_date type="Actual">August 1, 2008</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Blood was drawn for basal CRP from all patients</measure>
    <time_frame>12 months</time_frame>
    <description>The patients who were evaluated for the Blatt-Kupperman index and MENQOL questionnaire were given three months of treatment to the patient, which included 1.03 mg , Estradiol hemihydrate and 0.5 mg Norethindrone acetate</description>
  </primary_outcome>
  <enrollment type="Actual">45</enrollment>
  <condition>CRP</condition>
  <condition>Menopause</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A total of cases, whose hormone therapy was planned due to menopausal symptoms in the&#xD;
        menopause unit of our clinic, were evaluated in terms of admission, and non-acceptance&#xD;
        criteria, during 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 research and signing the form;&#xD;
&#xD;
          -  Postmenopausal women 45-55 years old&#xD;
&#xD;
          -  not having had menstruation for the past 6 months;&#xD;
&#xD;
          -  Hormone results compatible with menopause (FSH&gt; 20 milli-International unit(mIU) / mL,&#xD;
             E2 &lt;20 mIU / mL) and presence of vasomotor and/or menopausal symptoms (moderate to&#xD;
             severe);&#xD;
&#xD;
          -  no systemic disease (Diabetes, hypertension, hyperlipidemia, ischemic heart disease),&#xD;
             or no infectious disease in the past 2 weeks;&#xD;
&#xD;
          -  not taking any hormone therapy or medication for at least 2 months;&#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 (DM, HT, hyperlipidemia, ischemic heart 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;
          -  Stopping hormone therapy due to vaginal bleeding during hormone therapy&#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>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 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>CRP</keyword>
  <keyword>Estradiol</keyword>
  <keyword>Menopause-Specific Quality of Life questionnaire</keyword>
  <keyword>Norethindrone Acetate.</keyword>
  <!-- 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/NCT04424173
org study id: 2007/25
nct id: NCT04424173
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the effect of low dose combined estradiol and norethindrone acetate
      hormone therapy on serum CRP levels and life quality in natural menopause women. 45 natural
      menopause women who admitted to Karadeniz Technical University, Faculty of Medicine,
      Department of Obstetrics and Gynaecology for 1 year and diagnosed as menopause and planned to
      have hormone therapy for menopausal symptoms involved in this study. The serum CRP levels and
      vasomotor symptoms scores graded according to Blatt-Kupperman Index and life quality scores
      according to Menopause-Specific Quality of Life Questionnaire (MENQOL) in Turkish were
      recorded before and after (3 months later) low dose hormone treatment (1 mg Estradiol and 0.5
      mg Norethindrone acetate).
observational model: Cohort
time perspective: Prospective
measure: Blood was drawn for basal CRP from all patients
time frame: 12 months
description: The patients who were evaluated for the Blatt-Kupperman index and MENQOL questionnaire were given three months of treatment to the patient, which included 1.03 mg , Estradiol hemihydrate and 0.5 mg Norethindrone acetate
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
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: Suleyman Guven
investigator title: professor