<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/NCT03751800</url>
  </required_header>
  <id_info>
    <org_study_id>20061</org_study_id>
    <nct_id>NCT03751800</nct_id>
  </id_info>
  <brief_title>A Study Run at Multiple Study Sites to Test Whether the SAMANTA Questionnaire That is Used to Diagnose Heavy Menstrual Bleeding (HMB), Can Also be Used to Assess Changes of Severity of HMB in Women With HMB Who Are Treated During 12 Months With a Chronic Hormonal Treatment</brief_title>
  <acronym>SAMIRA</acronym>
  <official_title>An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women With Heavy Menstrual Bleeding (HMB)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
      A study run at multiple study sites in Spain to test whether the SAMANTA questionnaire that&#xD;
      is used to diagnose heavy menstrual bleeding (HMB), can also be used to assess changes of&#xD;
      severity of HMB in women with HMB who are treated during 12 months with a chronic hormonal&#xD;
      treatment. Patients that are treated with chronic hormonal treatment as Levonorgestrel (trade&#xD;
      name Mirena) or with a combination of estradiol valerate and dienogest (trade name Qlaira) or&#xD;
      with Medroxyprogesterone acetate (trade name Progevera) and any new hormonal treatment&#xD;
      marketed in Spain that has the indication for HMB in routine gynaecological practice are&#xD;
      observed for 12 months in this study or for a shorter period in time in case of withdrawal.&#xD;
      The study aims also to describe the overall satisfaction of women with their chronic hormonal&#xD;
      treatment for HMB and how the women think their menstrual bleeding has changed. In addition&#xD;
      the study aims to describe the changes of the score that is derived from the SAMANTA&#xD;
      questionnaire in relation to Quality of Life. Quality of Life is measured with the SF36v2&#xD;
      questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of&#xD;
      patient health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">May 18, 2021</completion_date>
  <primary_completion_date type="Actual">March 12, 2021</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>SAMANTA questionnaire score</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>SAMANTA questionnaire: is a existing and validated tool has shown that it can be effectively used by gynaecologists to easily discriminate among women with and without HMB</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between changes in SAMANTA score and changes in women's quality of life measured with SF36v2 questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>SF36v2: Generic health questionnaire, which comprises five dimensions: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">422</enrollment>
  <condition>Menorrhagia</condition>
  <arm_group>
    <arm_group_label>Women with HMB</arm_group_label>
    <description>Women with a diagnostic of HMB according to medical criteria and based on clinical judgment that have freely chosen a chronic hormonal treatment under therapeutic indication of HMB in Spain</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chronic hormonal treatment</intervention_name>
    <description>Drugs used in this study are described by the physicians during routine gynecological visits</description>
    <arm_group_label>Women with HMB</arm_group_label>
    <other_name>1. Mirena (Levonorgestrel - IUS)</other_name>
    <other_name>2. Qlaira (Estradiol valerate and dienogest)</other_name>
    <other_name>3. Progevera (Medroxyprogesterone acetate)</other_name>
    <other_name>and any new hormonal treatment marketed in Spain that has the indication for HMB</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women in childbearing age, with diagnosed HMB according to medical criteria and based on&#xD;
        clinical judgment and for whom the clinician decides, in agreement with the patient, to&#xD;
        prescribe a chronic hormonal treatment with the therapeutic indication of HMB or idiopathic&#xD;
        menorrhagia (IM) in Spain during a routine gynaecological visit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in childbearing age, ≥18 years old, not intending to become pregnant during the&#xD;
             next year.&#xD;
&#xD;
          -  Women diagnosed with heavy menstrual bleeding or idiopathic menorrhagia according to&#xD;
             medical criteria and based on clinical judgment.&#xD;
&#xD;
          -  Women for whom the clinician decides, in agreement with the patient, to prescribe any&#xD;
             of the available chronic hormonal treatments with the therapeutic indication of HMB in&#xD;
             Spain (Mirena, Qlaira or Progevera).&#xD;
&#xD;
          -  Women capable of reading and writing.&#xD;
&#xD;
          -  Women who signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with amenorrhea or menopause.&#xD;
&#xD;
          -  Women with contraindications and warnings with the chronic hormonal treatment&#xD;
             prescribed for HMB as per the summary of product characteristics (interaction with&#xD;
             concomitant medication, etc.).&#xD;
&#xD;
          -  Women receiving contraceptive hormonal therapy or using a copper intrauterine device.&#xD;
&#xD;
          -  Women on hormone replacement therapy.&#xD;
&#xD;
          -  Women with a history of malignancy.&#xD;
&#xD;
          -  Women with degenerative diseases that could directly negatively impact their daily&#xD;
             life.&#xD;
&#xD;
          -  Women who have given birth within the previous 6 months.&#xD;
&#xD;
          -  Women who are pregnant.&#xD;
&#xD;
          -  Women participating in an investigational program with interventions outside of&#xD;
             routine clinical practice.&#xD;
&#xD;
          -  Women with psychiatric disorders who are unable to make decisions and follow&#xD;
             instructions.&#xD;
&#xD;
          -  Women with concomitant medication that may lead to changes in the bleeding pattern&#xD;
             (e.g. antiplatelet and/ or anticoagulants).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heavy Menstrual Bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menorrhagia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Medroxyprogesterone Acetate</mesh_term>
    <mesh_term>Dienogest</mesh_term>
    <mesh_term>Levonorgestrel</mesh_term>
    <mesh_term>Medroxyprogesterone</mesh_term>
    <mesh_term>Estradiol</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/NCT03751800
org study id: 20061
nct id: NCT03751800
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A study run at multiple study sites in Spain to test whether the SAMANTA questionnaire that
      is used to diagnose heavy menstrual bleeding (HMB), can also be used to assess changes of
      severity of HMB in women with HMB who are treated during 12 months with a chronic hormonal
      treatment. Patients that are treated with chronic hormonal treatment as Levonorgestrel (trade
      name Mirena) or with a combination of estradiol valerate and dienogest (trade name Qlaira) or
      with Medroxyprogesterone acetate (trade name Progevera) and any new hormonal treatment
      marketed in Spain that has the indication for HMB in routine gynaecological practice are
      observed for 12 months in this study or for a shorter period in time in case of withdrawal.
      The study aims also to describe the overall satisfaction of women with their chronic hormonal
      treatment for HMB and how the women think their menstrual bleeding has changed. In addition
      the study aims to describe the changes of the score that is derived from the SAMANTA
      questionnaire in relation to Quality of Life. Quality of Life is measured with the SF36v2
      questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of
      patient health.
observational model: Cohort
time perspective: Prospective
measure: SAMANTA questionnaire score
time frame: Up to 12 months
description: SAMANTA questionnaire: is a existing and validated tool has shown that it can be effectively used by gynaecologists to easily discriminate among women with and without HMB
measure: Overall satisfaction with the chronic hormonal treatment measured with a user satisfaction questionnaire
time frame: Up to 12 months
measure: Changes in menstrual bleeding pattern measured with a user satisfaction questionnaire
time frame: Up to 12 months
measure: Correlation between changes in SAMANTA score and changes in women's quality of life measured with SF36v2 questionnaire
time frame: Up to 12 months
description: SF36v2: Generic health questionnaire, which comprises five dimensions: mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression
arm group label: Women with HMB
description: Women with a diagnostic of HMB according to medical criteria and based on clinical judgment that have freely chosen a chronic hormonal treatment under therapeutic indication of HMB in Spain
intervention type: Drug
intervention name: Chronic hormonal treatment
description: Drugs used in this study are described by the physicians during routine gynecological visits
arm group label: Women with HMB
other name: 1. Mirena (Levonorgestrel - IUS)
other name: 2. Qlaira (Estradiol valerate and dienogest)
other name: 3. Progevera (Medroxyprogesterone acetate)
other name: and any new hormonal treatment marketed in Spain that has the indication for HMB
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
url: http://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Menorrhagia
mesh term: Hemorrhage
mesh term: Medroxyprogesterone Acetate
mesh term: Dienogest
mesh term: Levonorgestrel
mesh term: Medroxyprogesterone
mesh term: Estradiol