<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/NCT04454775</url>
  </required_header>
  <id_info>
    <org_study_id>2005/47</org_study_id>
    <nct_id>NCT04454775</nct_id>
  </id_info>
  <brief_title>Raloxifene on Coagulation System in the Postmenopausal Women</brief_title>
  <official_title>The Effect of Raloxifene on the Parameters of Coagulation System in the Postmenopausal 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation&#xD;
      parameters in healthy postmenopausal women.&#xD;
&#xD;
      Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical&#xD;
      University Hospital at gynecology out-patient clinic from December 2005 to December 2006.&#xD;
      Local institutional ethics committee approved our study protocol and written informed consent&#xD;
      was obtained from all participants before enrollment. All patients received daily 600&#xD;
      milligrams of calcium and 400 international units of vitamin D (Cal-D-VİTA, Roche&#xD;
      Switzerland,). 60 milligrams of raloxifene HCI, which is a selective estrogen receptor&#xD;
      modulator (SERM), was added to treatment protocol if patients required hormonal therapy.&#xD;
      Patients receiving raloxifene therapy in addition to calcium and vitamin D therapy formed the&#xD;
      study group(n=50). Control group (n=30) was made up of the patients only receiving calcium&#xD;
      and vitamin D. Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III and&#xD;
      fibrinogen levels were measured in all patients before treatment. These measurements were&#xD;
      repeated at three and twelve months after treatment. Comparisons were performed with Student&#xD;
      t test or Mann Whitney test between the two groups and two-way ANOVA within the groups.&#xD;
      Proportions were compared with Fisher exact or Chi-square tests. Statistically analysis was&#xD;
      done with SPSS packet program (SPSS 11; SPSS Inc.) All p values were two-tailed and p&lt;0.05&#xD;
      was considered statistically significant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2005</start_date>
  <completion_date type="Actual">December 20, 2006</completion_date>
  <primary_completion_date type="Actual">December 1, 2006</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 coagulation parametres</measure>
    <time_frame>1 year</time_frame>
    <description>After collecting all blood, Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III, and fibrinogen levels were measured in all patients.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Raloxifene</condition>
  <condition>Postmenopausal Women</condition>
  <arm_group>
    <arm_group_label>group I</arm_group_label>
    <description>50 cases who received raloxifene and calcium therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group II</arm_group_label>
    <description>30 cases who received only calcium therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.</intervention_name>
    <arm_group_label>group I</arm_group_label>
    <arm_group_label>group II</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who applied to Menopause outpatient clinic with the approval of Karadeniz&#xD;
        Technical University Faculty of Medicine Ethics Committee numbered 2005/47 were evaluated&#xD;
        within the scope of the prospective study. Working time was determined as 12 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In the study planned on patients who have not had menstruation for at least one year,&#xD;
             or who have been in menopause naturally or surgically,&#xD;
&#xD;
          -  the presence of menopause was accepted if the patients' FSH level was&gt; 40 IU / L.&#xD;
             Verbal and written consent was obtained from all patients included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  . Hypertension,&#xD;
&#xD;
          -  diabetes mellitus,&#xD;
&#xD;
          -  hypercholesterolemia,&#xD;
&#xD;
          -  presence of hepatic-renal-thyroid-parathyroid-adrenal diseases,&#xD;
&#xD;
          -  cardiovascular,&#xD;
&#xD;
          -  cerebrovascular and thromboembolic diseases,&#xD;
&#xD;
          -  undiagnosed vaginal bleeding,&#xD;
&#xD;
          -  presence of hormone-dependent malignancy or anamnesis,&#xD;
&#xD;
          -  presence of varicose veins,&#xD;
&#xD;
          -  chronic drug use that disrupts sex steroid metabolism&#xD;
&#xD;
          -  cases with smoking&#xD;
&#xD;
          -  alcohol use&#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>42 Years</minimum_age>
    <maximum_age>62 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 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>raloxifene</keyword>
  <keyword>coagulation system</keyword>
  <keyword>von Willebrand factor</keyword>
  <keyword>Factor 8</keyword>
  <keyword>vitamin D</keyword>
  <keyword>protein C</keyword>
  <keyword>protein S</keyword>
  <keyword>antithrombin- III</keyword>
  <keyword>fibrinogen</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Protein C</mesh_term>
    <mesh_term>Antithrombins</mesh_term>
    <mesh_term>Antithrombin III</mesh_term>
    <mesh_term>Protein S</mesh_term>
  </intervention_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/NCT04454775
org study id: 2005/47
nct id: NCT04454775
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Objective: The aim of this study is to assess the effects of raloxifene HCl on coagulation
      parameters in healthy postmenopausal women.

      Material and method: 80 healthy postmenopausal women were evaluated at Karadeniz Technical
      University Hospital at gynecology out-patient clinic from December 2005 to December 2006.
      Local institutional ethics committee approved our study protocol and written informed consent
      was obtained from all participants before enrollment. All patients received daily 600
      milligrams of calcium and 400 international units of vitamin D (Cal-D-VİTA, Roche
      Switzerland,). 60 milligrams of raloxifene HCI, which is a selective estrogen receptor
      modulator (SERM), was added to treatment protocol if patients required hormonal therapy.
      Patients receiving raloxifene therapy in addition to calcium and vitamin D therapy formed the
      study group(n=50). Control group (n=30) was made up of the patients only receiving calcium
      and vitamin D. Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III and
      fibrinogen levels were measured in all patients before treatment. These measurements were
      repeated at three and twelve months after treatment. Comparisons were performed with Student
      t test or Mann Whitney test between the two groups and two-way ANOVA within the groups.
      Proportions were compared with Fisher exact or Chi-square tests. Statistically analysis was
      done with SPSS packet program (SPSS 11; SPSS Inc.) All p values were two-tailed and p<0.05
      was considered statistically significant.
observational model: Cohort
time perspective: Prospective
measure: Measuring coagulation parametres
time frame: 1 year
description: After collecting all blood, Factor 8, von Willebrand factor, protein C, protein S, antithrombin- III, and fibrinogen levels were measured in all patients.
arm group label: group I
description: 50 cases who received raloxifene and calcium therapy
arm group label: group II
description: 30 cases who received only calcium therapy
intervention type: Diagnostic Test
intervention name: coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.
arm group label: group I
arm group label: group II
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: 42 Years
maximum age: 62 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: Protein C
mesh term: Antithrombins
mesh term: Antithrombin III
mesh term: Protein S