<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/NCT02257671</url>
  </required_header>
  <id_info>
    <org_study_id>2010-020824-23</org_study_id>
    <nct_id>NCT02257671</nct_id>
  </id_info>
  <brief_title>Oral Contraceptives and Economic Behaviour</brief_title>
  <acronym>P-piller101</acronym>
  <official_title>The Influence of Oral Contraceptives on Mood, Sexuality and Economic Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood,&#xD;
      sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400&#xD;
      healthy women will be randomized to OC or placebo for a period of three months. Before and at&#xD;
      the end of treatment, mood and sexuality will be assessed by validated instruments. At the&#xD;
      end of treatment, each woman will participate in behavioral experiments testing&#xD;
      self-confidence, risk taking and altruism. The current project could fill the gap of&#xD;
      ignorance about causal effects of OCs on mood, sexuality and behavior. The results might&#xD;
      improve current practice as regards information about OCs, choice of hormonal contraceptive,&#xD;
      regimen and duration of use. As a consequence, this could lead to reduced discontinuation&#xD;
      rate, fewer unintended pregnancies and abortions. The project will contribute to an overall&#xD;
      improvement in women's reproductive health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>economic behaviour</measure>
    <time_frame>11 weeks</time_frame>
    <description>A modified dictator game will be used to measure altruistic behavior (Eckel and Grossman 1996). Each subject decides how to allocate money between herself and a charitable organisation. The size of the donation is our measure of altruism. Risk aversion is measured by a test where the subject makes several choices between a certain payoff and a 50/50 gamble to win a certain amount of money (Dohmen et al 2005). Competitiveness is defined as the extent to which women choose to compete in a task which involves solving as many simple mathematical exercises as possible during three minutes (Niederle and Vesterlund 2007).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>sexual behaviour</measure>
    <time_frame>baseline to 11 weeks</time_frame>
    <description>Sexual function will be assessed by the validated instruments Sexual Activity Log (SAL) (Derogatis et al 2004), Profile of Female Sexual Function (PFSF) (McHorney et al 2004, Derogatis et al 2004) and Personal Distress Scale (PDS, past 30 days) (Derogatis et al 2004, Leiblum et al 2006). The women are answering the questionnaires, which are all computerized, at the Women´s Health Research Unit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mood</measure>
    <time_frame>baseline to 11 weeks</time_frame>
    <description>Mood and health-related quality of life will be assessed by the Beck Depression Inventory (BDI) test (Lightfoot and Oliver 1985) and the Psychological General Well-Being Index (PGWB) (Dupuy 1984, Wiklund et al 1992).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Female Contraception</condition>
  <arm_group>
    <arm_group_label>Oral contraceptive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>oral dose of ethinylestradiol 0.03 mg + levonorgestrel 0.15 mg per day during 11 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral placebo capsule daily during 11 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral contraceptive</intervention_name>
    <description>Neovletta</description>
    <arm_group_label>Oral contraceptive</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>ethinylestradiol + levonorgestrel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy young women, aged 18-35 years, BMI 19-30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Risk factors for thrombosis, smoking, obesity, hypertension, diabetes and&#xD;
             estrogen/gestagen therapy the last three months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angelica L Hirschberg, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Angelica L Hirschberg, Professor</last_name>
    <phone>+46 8 517 733 26</phone>
    <email>angelica.linden-hirschberg@karolinska.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angelica L Hirschberg, Professor</last_name>
      <phone>+46 8 517 733 26</phone>
      <email>angelica.linden-hirschberg@karolinska.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 28, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Angelica Lindén Hirschberg</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contraceptive Agents</mesh_term>
    <mesh_term>Levonorgestrel</mesh_term>
    <mesh_term>Ethinyl Estradiol</mesh_term>
    <mesh_term>Contraceptives, Oral</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>February 18, 2020</submitted>
    <returned>March 4, 2020</returned>
    <submitted>October 9, 2022</submitted>
    <returned>August 22, 2023</returned>
  </pending_results>
  <!-- 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/NCT02257671
org study id: 2010-020824-23
nct id: NCT02257671
lead sponsor: 
collaborator: 
has dmc: No
The investigators aim is to evaluate effects of combined oral contraceptives (OC) on mood,
      sexuality and economic behaviour in a randomized, double-blind, placebo-controlled study. 400
      healthy women will be randomized to OC or placebo for a period of three months. Before and at
      the end of treatment, mood and sexuality will be assessed by validated instruments. At the
      end of treatment, each woman will participate in behavioral experiments testing
      self-confidence, risk taking and altruism. The current project could fill the gap of
      ignorance about causal effects of OCs on mood, sexuality and behavior. The results might
      improve current practice as regards information about OCs, choice of hormonal contraceptive,
      regimen and duration of use. As a consequence, this could lead to reduced discontinuation
      rate, fewer unintended pregnancies and abortions. The project will contribute to an overall
      improvement in women's reproductive health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: economic behaviour
time frame: 11 weeks
description: A modified dictator game will be used to measure altruistic behavior (Eckel and Grossman 1996). Each subject decides how to allocate money between herself and a charitable organisation. The size of the donation is our measure of altruism. Risk aversion is measured by a test where the subject makes several choices between a certain payoff and a 50/50 gamble to win a certain amount of money (Dohmen et al 2005). Competitiveness is defined as the extent to which women choose to compete in a task which involves solving as many simple mathematical exercises as possible during three minutes (Niederle and Vesterlund 2007).
measure: sexual behaviour
time frame: baseline to 11 weeks
description: Sexual function will be assessed by the validated instruments Sexual Activity Log (SAL) (Derogatis et al 2004), Profile of Female Sexual Function (PFSF) (McHorney et al 2004, Derogatis et al 2004) and Personal Distress Scale (PDS, past 30 days) (Derogatis et al 2004, Leiblum et al 2006). The women are answering the questionnaires, which are all computerized, at the Women´s Health Research Unit.
measure: mood
time frame: baseline to 11 weeks
description: Mood and health-related quality of life will be assessed by the Beck Depression Inventory (BDI) test (Lightfoot and Oliver 1985) and the Psychological General Well-Being Index (PGWB) (Dupuy 1984, Wiklund et al 1992).
arm group label: Oral contraceptive
arm group type: Active Comparator
description: oral dose of ethinylestradiol 0.03 mg + levonorgestrel 0.15 mg per day during 11 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Oral placebo capsule daily during 11 weeks
intervention type: Drug
intervention name: Oral contraceptive
description: Neovletta
arm group label: Oral contraceptive
arm group label: Placebo
other name: ethinylestradiol + levonorgestrel
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Angelica L Hirschberg, Professor
role: Principal Investigator
affiliation: Department of Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden
last name: Angelica L Hirschberg, Professor
phone: +46 8 517 733 26
email: angelica.linden-hirschberg@karolinska.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Angelica Lindén Hirschberg
investigator title: Professor
mesh term: Contraceptive Agents
mesh term: Levonorgestrel
mesh term: Ethinyl Estradiol
mesh term: Contraceptives, Oral
submitted: February 18, 2020
returned: March 4, 2020
submitted: October 9, 2022
returned: August 22, 2023