<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/NCT01705249</url>
  </required_header>
  <id_info>
    <org_study_id>KLIM-1408</org_study_id>
    <nct_id>NCT01705249</nct_id>
  </id_info>
  <brief_title>Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women</brief_title>
  <official_title>Bleeding Profile With Continuous Hormone Replacement Therapy in Postmenopausal Women: A Prospective, Open, Multicenter Trial of Activelle® Treatment Following Switch From Trisekvens®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novo Nordisk A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novo Nordisk A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is conducted in Europe. The aim of this study is to investigate the bleeding&#xD;
      profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone&#xD;
      acetate (NETA)).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2001</start_date>
  <completion_date type="Actual">June 6, 2003</completion_date>
  <primary_completion_date type="Actual">June 6, 2003</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postmenopausal women's acceptance of bleeding</measure>
    <time_frame>After 24 weeks of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding profile in postmenopausal women</measure>
    <time_frame>After 24 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of hot flushes and breast tenderness</measure>
    <time_frame>After 24 weeks of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">191</enrollment>
  <condition>Menopause</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>estradiol / norethisterone acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)</intervention_name>
    <description>After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®.</description>
    <arm_group_label>estradiol / norethisterone acetate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy women&#xD;
&#xD;
          -  At least 3 months on Trisekvens® before screening period&#xD;
&#xD;
          -  Ability to understand and comply with the protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 12 months or more than 36 months postmenopausal judged by the Investigator&#xD;
&#xD;
          -  Known, suspected, or past history of hormone dependent tumor/cancers&#xD;
&#xD;
          -  Deep venous thrombosis, active thrombophlebitis, thromboembolic disorders,&#xD;
             cerebrovascular accidents or past history of these conditions&#xD;
&#xD;
          -  Ischemic heart disease or myocardial infarction within 6 months prior to randomization&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kristiansand</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kristiansund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Larvik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Oslo</city>
        <zip>0309</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Trondheim</city>
        <zip>NO-7012</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Borås</city>
        <zip>503 32</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Göteborg</city>
        <zip>411 19</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Göteborg</city>
        <zip>418 33</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Kungsbacka</city>
        <zip>434 30</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Linköping</city>
        <zip>581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Linköping</city>
        <zip>582 20</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Linköping</city>
        <zip>582 22</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Norrköping</city>
        <zip>602 22</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Norrköping</city>
        <zip>602 32</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Sigtuna</city>
        <zip>193 30</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stockholm</city>
        <zip>111 37</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Stockholm</city>
        <zip>111 57</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Södertälje</city>
        <zip>151 23</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Uddevalla</city>
        <zip>451 30</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>February 27, 2017</last_update_submitted>
  <last_update_submitted_qc>February 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Norethindrone</mesh_term>
    <mesh_term>Norethindrone Acetate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
  </intervention_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/NCT01705249
org study id: KLIM-1408
nct id: NCT01705249
lead sponsor: 
has dmc: No
This study is conducted in Europe. The aim of this study is to investigate the bleeding
      profile after switch from Trisekvens® to Activelle® (1.0 mg estradiol / 0.5 mg norethisterone
      acetate (NETA)).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postmenopausal women's acceptance of bleeding
time frame: After 24 weeks of treatment
measure: Bleeding profile in postmenopausal women
time frame: After 24 weeks of treatment
measure: Acceptance of hot flushes and breast tenderness
time frame: After 24 weeks of treatment
arm group label: estradiol / norethisterone acetate
arm group type: Experimental
intervention type: Drug
intervention name: 1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)
description: After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®.
arm group label: estradiol / norethisterone acetate
criteria: 
gender: Female
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
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country: Norway
country: Sweden
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Norethindrone
mesh term: Norethindrone Acetate
mesh term: Estradiol