<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/NCT04455685</url>
  </required_header>
  <id_info>
    <org_study_id>LB2007</org_study_id>
    <nct_id>NCT04455685</nct_id>
  </id_info>
  <brief_title>Prevalence of Self-reported Premenstrual Syndrome and Analysis of Somatic and Psychoemotional Symptoms</brief_title>
  <acronym>LB2007</acronym>
  <official_title>Prevalence of Self-reported Premenstrual Syndrome and Analysis of Somatic and Psychoemotional Symptoms in Brazilian Women Aged 20 to 49 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Libbs Farmacêutica LTDA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Libbs Farmacêutica LTDA</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>
      In Brazil there are few published studies that study, the prevalence, symptoms and the&#xD;
      population's knowledge about the premenstrual syndrome of women of reproductive age, and that&#xD;
      correlate these data with the sociodemographic conditions of these women. In addition, given&#xD;
      the complexity of the diagnosis of PMS, the prevalence of PMS in the Brazilian female&#xD;
      population may be lower than the self-reported and published in these works, since not all&#xD;
      women who believe they suffer from PMS fully comply with the criteria contemplated in the&#xD;
      consensus for diagnosis of PMS. In this sense, this study aims to analyze the prevalence and&#xD;
      intensity of frequent symptoms of PMS reported by the Brazilian female population. The&#xD;
      information generated with this study may help to rethink behaviors to improve the health and&#xD;
      quality of life of these women, as well as offer tools for decision making related to the&#xD;
      need for early and effective treatment of PMS, whose disorders are associated with both the&#xD;
      fall present and future quality of life for women, as well as all of their family, social and&#xD;
      professional coexistence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Brazil and Latin America there are still few published studies that study, the prevalence,&#xD;
      symptoms and the population's knowledge about the premenstrual syndrome of women of&#xD;
      reproductive age, and that correlate these data with the sociodemographic, socioeconomic and&#xD;
      sociocultural conditions of these women .&#xD;
&#xD;
      In the investigator's view, this study brings value not only to contribute to the&#xD;
      understanding and demystification of PMS by society in general, but also for the&#xD;
      professionals who assist these women. The data currently used in Brazil, and which are&#xD;
      frequently used to guide public health policies, are mostly the result of research carried&#xD;
      out in other countries, and which may not correspond to the national reality.&#xD;
&#xD;
      The information generated with this study may help to rethink behaviors to improve the health&#xD;
      and quality of life of these women, at this stage in which comprehensive attention to the&#xD;
      health and needs of this population should be given, often providing contraceptive methods&#xD;
      that offer, as a benefit relief of symptoms related to PMS. The data from this research may&#xD;
      also offer tools for decision making related to the need for early and effective treatment of&#xD;
      PMS, whose disorders are associated with both the decrease in the present and future quality&#xD;
      of life for the woman, as well as all of her family life, social and professional.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">June 29, 2020</completion_date>
  <primary_completion_date type="Actual">June 29, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>sociodemographic data</measure>
    <time_frame>4 months</time_frame>
    <description>Data from at least 1022 (one thousand and twenty-two) women, aged between 20 and 49 years old, living in the five regions of Brazil will be retrieved at random. This information will be organized in a data collection form developed for this study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>somatic and psychoemotional premenstrual symptoms data</measure>
    <time_frame>4 months</time_frame>
    <description>data related to somatic and psychoemotional premenstrual symptoms, with their intensity measured by a 4-point Likert scale (0 = none; 1 = mild; 2 = moderate; 3 = severe), degree of interference of these symptoms in daily life and whether the participants would take contraceptives as a method of treating PMS. These data will be organized in a data collection form prepared for this study.</description>
  </primary_outcome>
  <enrollment type="Actual">1022</enrollment>
  <condition>Premenstrual Syndrome</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>anonymised data collection</intervention_name>
    <description>The population of the present study corresponds to a sample of previous market research. Data from participants from the five main regions of Brazil (North, Northeast, Midwest, South, Southeast) will be selected at random and according to the sample size calculation.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population of the present study corresponds to a sample of previous market research.&#xD;
        Data from participants from the five main regions of Brazil (North, Northeast, Midwest,&#xD;
        South, Southeast) will be selected at random and according to the sample size calculation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Data from questionnaires that integrate the anonymous secondary database generated in&#xD;
             the period between 20/02/2019 and 03/20/2020, of female participants aged between 20&#xD;
             and 49 years, in which all necessary information has been filled out according to the&#xD;
             participant's profile.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The present study does not include exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Augusto Theodoro de Figueiredo</name>
      <address>
        <city>São Paulo</city>
        <zip>01140050</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Premenstrual Syndrome</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/NCT04455685
org study id: LB2007
nct id: NCT04455685
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Brazil there are few published studies that study, the prevalence, symptoms and the
      population's knowledge about the premenstrual syndrome of women of reproductive age, and that
      correlate these data with the sociodemographic conditions of these women. In addition, given
      the complexity of the diagnosis of PMS, the prevalence of PMS in the Brazilian female
      population may be lower than the self-reported and published in these works, since not all
      women who believe they suffer from PMS fully comply with the criteria contemplated in the
      consensus for diagnosis of PMS. In this sense, this study aims to analyze the prevalence and
      intensity of frequent symptoms of PMS reported by the Brazilian female population. The
      information generated with this study may help to rethink behaviors to improve the health and
      quality of life of these women, as well as offer tools for decision making related to the
      need for early and effective treatment of PMS, whose disorders are associated with both the
      fall present and future quality of life for women, as well as all of their family, social and
      professional coexistence.
In Brazil and Latin America there are still few published studies that study, the prevalence,
      symptoms and the population's knowledge about the premenstrual syndrome of women of
      reproductive age, and that correlate these data with the sociodemographic, socioeconomic and
      sociocultural conditions of these women .

      In the investigator's view, this study brings value not only to contribute to the
      understanding and demystification of PMS by society in general, but also for the
      professionals who assist these women. The data currently used in Brazil, and which are
      frequently used to guide public health policies, are mostly the result of research carried
      out in other countries, and which may not correspond to the national reality.

      The information generated with this study may help to rethink behaviors to improve the health
      and quality of life of these women, at this stage in which comprehensive attention to the
      health and needs of this population should be given, often providing contraceptive methods
      that offer, as a benefit relief of symptoms related to PMS. The data from this research may
      also offer tools for decision making related to the need for early and effective treatment of
      PMS, whose disorders are associated with both the decrease in the present and future quality
      of life for the woman, as well as all of her family life, social and professional.
observational model: Other
time perspective: Retrospective
measure: sociodemographic data
time frame: 4 months
description: Data from at least 1022 (one thousand and twenty-two) women, aged between 20 and 49 years old, living in the five regions of Brazil will be retrieved at random. This information will be organized in a data collection form developed for this study.
measure: somatic and psychoemotional premenstrual symptoms data
time frame: 4 months
description: data related to somatic and psychoemotional premenstrual symptoms, with their intensity measured by a 4-point Likert scale (0 = none; 1 = mild; 2 = moderate; 3 = severe), degree of interference of these symptoms in daily life and whether the participants would take contraceptives as a method of treating PMS. These data will be organized in a data collection form prepared for this study.
intervention type: Other
intervention name: anonymised data collection
description: The population of the present study corresponds to a sample of previous market research. Data from participants from the five main regions of Brazil (North, Northeast, Midwest, South, Southeast) will be selected at random and according to the sample size calculation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Syndrome
mesh term: Premenstrual Syndrome