<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/NCT03306459</url>
  </required_header>
  <id_info>
    <org_study_id>B/2017/0614</org_study_id>
    <nct_id>NCT03306459</nct_id>
  </id_info>
  <brief_title>Psychological Traits, Sexuality and Quality of Life in Patients With Polycystic Ovary Syndrome</brief_title>
  <official_title>Hospital Clínic Barcelona</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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 prospective assessment of psychological characteristics, quality of life and sexuality in&#xD;
      naïve patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project with PCOS patients include an assessment of quality of life and sexuality in&#xD;
      naïve patients.&#xD;
&#xD;
      Hypothesizing that PCOS women would show higher rates of psychological alterations, this&#xD;
      study is aimed to investigate the association between polycystic ovary syndrome (PCOS) and&#xD;
      psychological disturbances, including anger and to analyze whether the&#xD;
      biochemical/phenotypical features of PCOS may play a role in the type and severity of&#xD;
      psychological disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 9, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>january 9th 2018-january 9th 2019</time_frame>
    <description>results of SF-36</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sexuality</measure>
    <time_frame>january 9th 2018-january 9th 2019</time_frame>
    <description>Results of FSFI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological distress</measure>
    <time_frame>january 9th 2018-january 9th 2019</time_frame>
    <description>Results of Symptom Checklist-90-Revision (SCL-90-R)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anger and aggressiveness</measure>
    <time_frame>january 9th 2018-january 9th 2019</time_frame>
    <description>results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Biochemical markers</measure>
    <time_frame>january 9th 2018-january 9th 2019</time_frame>
    <description>Results of blood tests including biochemistry and hormones analysis</description>
  </other_outcome>
  <other_outcome>
    <measure>Phenotipical traits</measure>
    <time_frame>january 9th 2018-january 9th 2019</time_frame>
    <description>Record of hirsutism, acne, alopecia, and other hyperandrogenic symptoms</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>1/PCOS</arm_group_label>
    <description>The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A) which include the presence of oligo-anovulation (cycles lasting &gt;35 days or amenorrhea) and hyperandrogenemia /hyperandrogenism (hirsutism or obvious acne or pronounced alopecia). All patients should have bilateral polycystic ovaries morphology on ultrasound. Additionally, the authors have decided to enroll PCOS patients that are all without pregnancy desire at the moment they fill out the questionnaires, in order to control for the potential confounding role of infertility on psychological outcomes. Different pituitary, adrenal, ovarian, thyroid or metabolic diseases will be excluded</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2/CONTROL</arm_group_label>
    <description>The authors will enroll a control group of 30 women, age- matched with the PCOS women, from consecutive women controlled in the same outpatient clinic who met the following inclusion criteria: history of irregular menstrual cycle in absence of severe gynecologic and non-gynecologic diseases. This PCOS sample will be entirely constituted by women with no pregnancy desire; therefore, with the aim to limit the potential effect of the unfulfilled wish to conceive in the final results; additionally, infertile women will not admitted into the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SF-36 (Short Form Health Survey)</intervention_name>
    <description>Symptom Checklist-90-Revision (SCL-90-R): self-report questionnaire of 90 items on a 5-point Likert scale clustered in 9 primary scales (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism).&#xD;
State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2): self-report questionnaire of 57-items on a 4-point scale distributed in different dimensions: State-Anger, Trait-Anger Expression Anger (in-out) and Anger Control (in-out) Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health.&#xD;
Female Sexual Function Index (FSFI) a 19-item self-report measure of female sexual function providing scores on 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) as well as a total score.</description>
    <arm_group_label>1/PCOS</arm_group_label>
    <arm_group_label>2/CONTROL</arm_group_label>
    <other_name>Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam&#xD;
        diagnostic criteria (Rotterdam phenotype A)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        PCOS patients without gestational desire who met the following criteria&#xD;
&#xD;
          -  Oligomenorrhea (cycles lasting &gt;35 days) or amenorrhea (no periods in 6 months)&#xD;
&#xD;
          -  Hyperandrogenemia/hyperandrogenism Hirsutism Ferriman-Gallwey score &gt; 12 Obvious acne&#xD;
             or pronounced alopecia Androgen levels over normal female range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior psychiatric diagnosis&#xD;
&#xD;
          -  Current use of psychiatric medications&#xD;
&#xD;
          -  Difficulties with language comprehension in case of non-nationals.&#xD;
&#xD;
          -  Yatrogenic hirsutism,&#xD;
&#xD;
          -  Other endocrine deseases with hyperandrogenism or that may influence the final results&#xD;
             Ovarian or adrenal neoplasia Prolactinoma Cushing's syndrome Congenital adrenal&#xD;
             hyperplasia Diabetes mellitus Thromboembolic disease&#xD;
&#xD;
          -  Patients who had received any drug therapy for hirsutism over the last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Camil Castelo-Branco, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Clínic. University of Barcelona</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Camil Castelo-Branco, MD PhD</last_name>
    <phone>1679999037</phone>
    <email>ccastelo@clinic.cat</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Camil Castelo-Branco</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Clínic</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <contact>
      <last_name>Camil Castelo-Branco, MD PhD</last_name>
      <phone>+342275436</phone>
      <email>ccastelo@clinic.cat</email>
    </contact>
    <investigator>
      <last_name>Juliia Naumova, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 19, 2017</last_update_submitted>
  <last_update_submitted_qc>October 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Camil Castelo-Branco</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Sexuality</keyword>
  <keyword>Psychological traits</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03306459
org study id: B/2017/0614
nct id: NCT03306459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective assessment of psychological characteristics, quality of life and sexuality in
      naïve patients.
This project with PCOS patients include an assessment of quality of life and sexuality in
      naïve patients.

      Hypothesizing that PCOS women would show higher rates of psychological alterations, this
      study is aimed to investigate the association between polycystic ovary syndrome (PCOS) and
      psychological disturbances, including anger and to analyze whether the
      biochemical/phenotypical features of PCOS may play a role in the type and severity of
      psychological disorders.
observational model: Case-Control
time perspective: Prospective
measure: Quality of Life
time frame: january 9th 2018-january 9th 2019
description: results of SF-36
measure: Sexuality
time frame: january 9th 2018-january 9th 2019
description: Results of FSFI
measure: Psychological distress
time frame: january 9th 2018-january 9th 2019
description: Results of Symptom Checklist-90-Revision (SCL-90-R)
measure: Anger and aggressiveness
time frame: january 9th 2018-january 9th 2019
description: results of State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2)
measure: Biochemical markers
time frame: january 9th 2018-january 9th 2019
description: Results of blood tests including biochemistry and hormones analysis
measure: Phenotipical traits
time frame: january 9th 2018-january 9th 2019
description: Record of hirsutism, acne, alopecia, and other hyperandrogenic symptoms
arm group label: 1/PCOS
description: The authors will select 30 PCOS patients who met the more strict and conservative Rotterdam diagnostic criteria (Rotterdam phenotype A) which include the presence of oligo-anovulation (cycles lasting >35 days or amenorrhea) and hyperandrogenemia /hyperandrogenism (hirsutism or obvious acne or pronounced alopecia). All patients should have bilateral polycystic ovaries morphology on ultrasound. Additionally, the authors have decided to enroll PCOS patients that are all without pregnancy desire at the moment they fill out the questionnaires, in order to control for the potential confounding role of infertility on psychological outcomes. Different pituitary, adrenal, ovarian, thyroid or metabolic diseases will be excluded
arm group label: 2/CONTROL
description: The authors will enroll a control group of 30 women, age- matched with the PCOS women, from consecutive women controlled in the same outpatient clinic who met the following inclusion criteria: history of irregular menstrual cycle in absence of severe gynecologic and non-gynecologic diseases. This PCOS sample will be entirely constituted by women with no pregnancy desire; therefore, with the aim to limit the potential effect of the unfulfilled wish to conceive in the final results; additionally, infertile women will not admitted into the control group.
intervention type: Diagnostic Test
intervention name: SF-36 (Short Form Health Survey)
description: Symptom Checklist-90-Revision (SCL-90-R): self-report questionnaire of 90 items on a 5-point Likert scale clustered in 9 primary scales (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism).
State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2): self-report questionnaire of 57-items on a 4-point scale distributed in different dimensions: State-Anger, Trait-Anger Expression Anger (in-out) and Anger Control (in-out) Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health.
Female Sexual Function Index (FSFI) a 19-item self-report measure of female sexual function providing scores on 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) as well as a total score.
arm group label: 1/PCOS
arm group label: 2/CONTROL
other name: Female Sexual Function Index; Symptom Checklist-90-R; State-Trait-Anger-Expression-Inventory
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Camil Castelo-Branco, MD PhD
role: Study Director
affiliation: Hospital Clínic. University of Barcelona
last name: Camil Castelo-Branco, MD PhD
phone: 1679999037
email: ccastelo@clinic.cat
last name: Camil Castelo-Branco
facility: 
contact: 
investigator: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Camil Castelo-Branco
investigator title: Professor
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
sharing ipd: No