<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/NCT02984696</url>
  </required_header>
  <id_info>
    <org_study_id>Hypotalamic Amenorrhea-01</org_study_id>
    <nct_id>NCT02984696</nct_id>
  </id_info>
  <brief_title>Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea</brief_title>
  <official_title>Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of the Sacred Heart</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant&#xD;
      capacity, clinical, endocrine and metabolic features in women affected by hypotalamic&#xD;
      amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol&#xD;
      daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six&#xD;
      months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone&#xD;
      metabolism parameters are evaluated before and after therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Anti-oxidant Capacity</measure>
    <time_frame>6 Month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bone Mineral Density</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osteocalcin</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estrogen levels</measure>
    <time_frame>6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of Cycles in 6 months</measure>
    <time_frame>6 Months</time_frame>
    <description>n° of menstrual cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>beta crosslaps</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hypothalamic Amenorrhea</condition>
  <arm_group>
    <arm_group_label>Hormonal Replace Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1 mg of transdermal estradiol daily and 10mg of oral MPA</intervention_name>
    <arm_group_label>Hormonal Replace Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypotalamic Amenorrhea&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr&#xD;
             oral glucose tolerance test)&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  significant liver or renal impairment&#xD;
&#xD;
          -  other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal)&#xD;
&#xD;
          -  neoplasms&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catholic university of Sacred Heart</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosanna Apa, MD</last_name>
      <email>krimisa@libero.it</email>
    </contact>
    <investigator>
      <last_name>Rosanna Apa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>March 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 3, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 3, 2016</last_update_submitted>
  <last_update_submitted_qc>December 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>Rosanna Apa</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amenorrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02984696
org study id: Hypotalamic Amenorrhea-01
nct id: NCT02984696
lead sponsor: 
has dmc: No
The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant
      capacity, clinical, endocrine and metabolic features in women affected by hypotalamic
      amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol
      daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six
      months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone
      metabolism parameters are evaluated before and after therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total Anti-oxidant Capacity
time frame: 6 Month
measure: Bone Mineral Density
time frame: 6 Months
measure: Osteocalcin
time frame: 6 Months
measure: Estrogen levels
time frame: 6 Months
measure: number of Cycles in 6 months
time frame: 6 Months
description: n° of menstrual cycle
measure: beta crosslaps
time frame: 6 months
arm group label: Hormonal Replace Therapy
arm group type: Experimental
description: 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months
intervention type: Drug
intervention name: 1 mg of transdermal estradiol daily and 10mg of oral MPA
arm group label: Hormonal Replace Therapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Rosanna Apa
investigator title: Professor
mesh term: Amenorrhea
mesh term: Estradiol
sharing ipd: Undecided