<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/NCT01674426</url>
  </required_header>
  <id_info>
    <org_study_id>MH50748</org_study_id>
    <nct_id>NCT01674426</nct_id>
  </id_info>
  <brief_title>Pathogenesis of Functional Hypothalamic Amenorrhea</brief_title>
  <official_title>Pathogenesis of Functional Hypothalamic Amenorrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized pilot study of the use of cognitive behavior therapy versus observation&#xD;
      to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study enrollment was completed in 2003. The study results are being analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 1997</start_date>
  <completion_date type="Actual">August 2003</completion_date>
  <primary_completion_date type="Actual">August 2003</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ovarian function</measure>
    <time_frame>Change before and after 20 weeks of CBT or observation</time_frame>
    <description>The change in ovarian function was assessed by comparing ovarian function before and after 20 weeks of CBT or observation using menses and serial estradiol and progesterone level as indices of ovarian function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>metabolism</measure>
    <time_frame>Change before and after 20 weeks of CBT or observation</time_frame>
    <description>The change in metabolism was assessed by measuring levels of cortisol, TSH, T4, free T4, T3, free T3, leptin in blood and by measuring weight before and after 20 weeks of CBT or observation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>psychological inventories</measure>
    <time_frame>Change before and after 20 weeks of CBT or observation</time_frame>
    <description>Attitudes were assessed before and after 20 weeks of CBT or observation using psychological inventories</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Disorder of Endocrine Ovary</condition>
  <condition>Hypersecretion; Cortisol</condition>
  <condition>Metabolic Disturbance</condition>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive behavior therapy consisting of 16 sessions over 20 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>observation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive behavior therapy</intervention_name>
    <description>16 sessions of 45 minutes each to review stress management</description>
    <arm_group_label>Cognitive behavior therapy</arm_group_label>
    <arm_group_label>observation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with functional hypothalamic amenorrhea&#xD;
&#xD;
          -  day awake / night asleep schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  eating disorders, depression, excessive exercise or any other cause of amenorrhea and&#xD;
             anovulation other than functional hypothalamic amenorrhea&#xD;
&#xD;
          -  weight loss greater than 10 pounds when amenorrhea developed&#xD;
&#xD;
          -  running more than 10 miles per week or exercising more than 10 hours per week&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah L Berga, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5.</citation>
    <PMID>14556820</PMID>
  </results_reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>June 28, 2017</last_update_submitted>
  <last_update_submitted_qc>June 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Sarah Berga</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>functional hypothalamic amenorrhea</keyword>
  <keyword>stress induced anovulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amenorrhea</mesh_term>
    <mesh_term>Stress, 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/NCT01674426
org study id: MH50748
nct id: NCT01674426
lead sponsor: 
collaborator: 
has dmc: No
This is a randomized pilot study of the use of cognitive behavior therapy versus observation
      to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.
The study enrollment was completed in 2003. The study results are being analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ovarian function
time frame: Change before and after 20 weeks of CBT or observation
description: The change in ovarian function was assessed by comparing ovarian function before and after 20 weeks of CBT or observation using menses and serial estradiol and progesterone level as indices of ovarian function
measure: metabolism
time frame: Change before and after 20 weeks of CBT or observation
description: The change in metabolism was assessed by measuring levels of cortisol, TSH, T4, free T4, T3, free T3, leptin in blood and by measuring weight before and after 20 weeks of CBT or observation
measure: psychological inventories
time frame: Change before and after 20 weeks of CBT or observation
description: Attitudes were assessed before and after 20 weeks of CBT or observation using psychological inventories
arm group label: Cognitive behavior therapy
arm group type: Experimental
description: Cognitive behavior therapy consisting of 16 sessions over 20 weeks
arm group label: observation
arm group type: Placebo Comparator
description: Subjects were called by telephone but were not given cognitive behavior therapy until the study phase was completed
intervention type: Behavioral
intervention name: Cognitive behavior therapy
description: 16 sessions of 45 minutes each to review stress management
arm group label: Cognitive behavior therapy
arm group label: observation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Sarah L Berga, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
citation: Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5.
PMID: 14556820
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Sarah Berga
investigator title: Professor
mesh term: Amenorrhea
mesh term: Stress, Psychological