<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/NCT01702818</url>
  </required_header>
  <id_info>
    <org_study_id>H10-02067</org_study_id>
    <nct_id>NCT01702818</nct_id>
  </id_info>
  <brief_title>Stress Hormones, Mood and Women's Sexual Desire (MODEST)</brief_title>
  <acronym>MODEST</acronym>
  <official_title>Stress Hormones, Mood and Women's Sexual Desire (MODEST)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone&#xD;
      activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although&#xD;
      DHEA is a precursor of testosterone it has other actions including involvement in the stress&#xD;
      system. It is also linked to mood. This study focuses on measures of childhood stress,&#xD;
      current mood and salivary stress hormones, in women with and without HSDD. We hypothesize&#xD;
      that low levels of DHEA reflect dysfunction of the neuroendocrine stress response system&#xD;
      involving the brain, pituitary and adrenal glands where DHEA is produced.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DHEA levels</measure>
    <time_frame>Data is collected at 4 time points on 3 separate days</time_frame>
    <description>DHEA levels derived from saliva samples.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cortisol levels</measure>
    <time_frame>Data is collected at 4 time points on 3 separate days</time_frame>
    <description>Cortisol levels derived from saliva samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>data is collected at single time point</time_frame>
    <description>Depression will be measured by the Beck Depression Inventory (Beck &amp; Beamesderfer, 1974)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>Perceived stress will be measured with the 10-item Perceived Stress Scale (Roberti, Harrington &amp; Storch 2006)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual function</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>Self-report sexual function will be measured with the Sexual Interest and Desire Inventory (Clayton et al. 2006))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship satisfaction</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988) and the Dyadic Adjustment Scale (Spanier, 1976)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>History of childhood trauma</measure>
    <time_frame>dat is collected at a single timepoint</time_frame>
    <description>History of childhood trauma will be determined with the Childhood Trauma Questionnaire (Bernstein &amp; Fink, 1995)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>History of childhood sexual abuse</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>History of Childhood Sexual Abuse will be determined with the Childhood Sexual Abuse Measure (Finkelhor, 1979)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD symptoms</measure>
    <time_frame>data is collected at a single time point</time_frame>
    <description>Presence and severity of post traumatic stress disorder symptoms will be determined through the Clinician-Administered PTSD Scale (Blake et al. 1998)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">324</enrollment>
  <condition>Hypoactive Sexual Desire Disorder (HSDD)</condition>
  <arm_group>
    <arm_group_label>HSDD group</arm_group_label>
    <description>Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      saliva samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women with and without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for HSDD Group:&#xD;
&#xD;
          -  (1) diagnosis of HSDD&#xD;
&#xD;
          -  (2) over 19 years of age&#xD;
&#xD;
          -  (3) sexual complaints of low desire of at least 12 months duration.&#xD;
&#xD;
        Inclusion criteria for Control group:&#xD;
&#xD;
          -  (1) sexually healthy, i.e., must not meet criteria for any sexual dysfunction, as&#xD;
             determined by a telephone screening, followed by an in-person structured assessment,&#xD;
             the Decreased Sexual Desire Screener (DSDS)&#xD;
&#xD;
          -  (2) over 19 years of age.&#xD;
&#xD;
        Exclusion Criteria for both Control and HSDD groups:&#xD;
&#xD;
          -  (1) lack of fluency in English&#xD;
&#xD;
          -  (2) currently meeting DSM-IV-TR diagnostic criteria for major depressive disorder as&#xD;
             measured by an in-person, semi-structured interview based on the Major Depressive&#xD;
             Disorder Module of the Structured Clinical Interview for DSM-IV-TR (SCID-I&#xD;
&#xD;
          -  (3) current use of prescription drugs such as antidepressants or other medications&#xD;
             with known sexual side effects (e.g., glucocorticoids, aromatase inhibitors), or known&#xD;
             effects on cortisol metabolism, or use of illicit drugs&#xD;
&#xD;
          -  (4) use of hormone replacement therapy or hormonal contraceptives;&#xD;
&#xD;
          -  (5) a body mass index (BMI) &lt;18.5 or &gt;29.9&#xD;
&#xD;
          -  (6) cigarette smoking&#xD;
&#xD;
          -  (7) chronic medical or psychiatric disease with potential to interfere with sexual&#xD;
             function (e.g., chronic neurological disease, cardiac and liver disease, eating&#xD;
             disorders, anxiety disorders)&#xD;
&#xD;
          -  (8) chronic pain with intercourse not relieved by a vaginal lubricant&#xD;
&#xD;
          -  (9) loss of genital responsiveness&#xD;
&#xD;
          -  (10) significant relationship discord&#xD;
&#xD;
          -  (11) not having a family physician who we could contact if depression is diagnosed&#xD;
             during the assessment&#xD;
&#xD;
          -  (12) difficulty in complying with questionnaires or in completing interview.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rosemary Basson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lori A Brotto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>British Columbia Centre for Sexual Medicine</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://brottolab.med.ubc.ca/</url>
    <description>UBC Sexual Health Lab</description>
  </link>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Lori Brotto</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Hypoactive Sexual Desire Disorder</keyword>
  <keyword>HSDD</keyword>
  <keyword>Cortisol</keyword>
  <keyword>DHEA</keyword>
  <keyword>Stress Hormones</keyword>
  <keyword>Sexual Desire</keyword>
  <keyword>Mood</keyword>
  <keyword>Sexual Function</keyword>
  <keyword>Childhood Maltreatment</keyword>
  <keyword>Childhood Abuse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypokinesia</mesh_term>
    <mesh_term>Sexual Dysfunctions, Psychological</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/NCT01702818
org study id: H10-02067
nct id: NCT01702818
lead sponsor: 
has dmc: No
Women with Hypoactive sexual desire disorder (HSDD) have all measures of testosterone
      activity comparable to controls but lower levels of dehydroepiandrosterone (DHEA). Although
      DHEA is a precursor of testosterone it has other actions including involvement in the stress
      system. It is also linked to mood. This study focuses on measures of childhood stress,
      current mood and salivary stress hormones, in women with and without HSDD. We hypothesize
      that low levels of DHEA reflect dysfunction of the neuroendocrine stress response system
      involving the brain, pituitary and adrenal glands where DHEA is produced.
observational model: Other
time perspective: Cross-Sectional
measure: DHEA levels
time frame: Data is collected at 4 time points on 3 separate days
description: DHEA levels derived from saliva samples.
measure: Cortisol levels
time frame: Data is collected at 4 time points on 3 separate days
description: Cortisol levels derived from saliva samples.
measure: Depression
time frame: data is collected at single time point
description: Depression will be measured by the Beck Depression Inventory (Beck & Beamesderfer, 1974)
measure: Perceived stress
time frame: data is collected at a single time point
description: Perceived stress will be measured with the 10-item Perceived Stress Scale (Roberti, Harrington & Storch 2006)
measure: Sexual function
time frame: data is collected at a single time point
description: Self-report sexual function will be measured with the Sexual Interest and Desire Inventory (Clayton et al. 2006))
measure: Relationship satisfaction
time frame: data is collected at a single time point
description: Relationship satisfaction will be measured with the Relationship Assessment Scale (Hendrick, 1988) and the Dyadic Adjustment Scale (Spanier, 1976)
measure: History of childhood trauma
time frame: dat is collected at a single timepoint
description: History of childhood trauma will be determined with the Childhood Trauma Questionnaire (Bernstein & Fink, 1995)
measure: History of childhood sexual abuse
time frame: data is collected at a single time point
description: History of Childhood Sexual Abuse will be determined with the Childhood Sexual Abuse Measure (Finkelhor, 1979)
measure: PTSD symptoms
time frame: data is collected at a single time point
description: Presence and severity of post traumatic stress disorder symptoms will be determined through the Clinician-Administered PTSD Scale (Blake et al. 1998)
arm group label: HSDD group
description: Women with a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
arm group label: Control Group
description: Women without a diagnosis of Hypoactive Sexual Desire Disorder (HSDD).
saliva samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rosemary Basson, MD
role: Principal Investigator
affiliation: University of British Columbia
last name: Lori A Brotto, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
url: http://brottolab.med.ubc.ca/
description: UBC Sexual Health Lab
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lori Brotto
investigator title: Associate Professor
mesh term: Hypokinesia
mesh term: Sexual Dysfunctions, Psychological