<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/NCT02224313</url>
  </required_header>
  <id_info>
    <org_study_id>CRC-VgCy</org_study_id>
    <nct_id>NCT02224313</nct_id>
  </id_info>
  <brief_title>Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women</brief_title>
  <official_title>Effect of Oral Estradiol and Progesterone Therapy on Vaginal Cytokines in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intira Sriprasert</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TherapeuticsMD</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Virginia Medical School</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the vaginal health between premenopausal and&#xD;
      postmenopausal women before and after using oral &quot;estradiol&quot; for 14 days then &quot;estradiol&quot; and&#xD;
      &quot;progesterone&quot; for 14 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research project recruits 10 healthy, premenopausal women (aged 20-40 years-old) with&#xD;
      regular menstrual cycle with interval of 24-35 days and duration of 2-7 days and 10 healthy&#xD;
      postmenopausal women (aged 45-60 years-old) with an intact uterus and at least 12 months but&#xD;
      not more than 36 months of spontaneous amenorrhea.&#xD;
&#xD;
      Premenopausal women will not receive any study medication(s). Postmenopausal women will be&#xD;
      assigned the intervention described below.&#xD;
&#xD;
      • Oral &quot;estradiol&quot; 1.0 mg tablet for 14 days, then oral &quot;estradiol&quot; 1.0 mg tablet and&#xD;
      &quot;progesterone&quot; 100 mg capsule for 14 days&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vaginal Cytokines at Baseline</measure>
    <time_frame>At baseline visit</time_frame>
    <description>Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vaginal Cytokines During Follow-up</measure>
    <time_frame>At 14 days and 28 days follow-up</time_frame>
    <description>Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Menopause</condition>
  <arm_group>
    <arm_group_label>1.Premenopausal women</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2.Postmenopausal women with hormones</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral hormone therapy will be given to women in this group. Daily dose of oral &quot;estradiol&quot; 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral &quot;estradiol&quot; 1 mg and &quot;progesterone&quot; 100 mg for 14 days will be given during the following 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral estradiol 1.0 mg</intervention_name>
    <description>one tablet of oral estradiol 1.0 mg once a day for 28 days</description>
    <arm_group_label>2.Postmenopausal women with hormones</arm_group_label>
    <other_name>Estrace</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral progesterone 100 mg</intervention_name>
    <description>one tablet of oral progesterone 100 mg once a day for 14 days</description>
    <arm_group_label>2.Postmenopausal women with hormones</arm_group_label>
    <other_name>Prometrium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premenopausal and Postmenopausal women:&#xD;
&#xD;
               1. Female between the ages of 20 and 40 years (premenopausal arm), OR be a female&#xD;
                  between the ages of 45 and 65 years (postmenopausal arm) willing to participate&#xD;
                  in the study, as documented by signing the informed consent form.&#xD;
&#xD;
               2. Postmenopausal women with an intact uterus and at least 12 months of spontaneous&#xD;
                  amenorrhea (postmenopausal arm), OR be a premenopausal women with regular&#xD;
                  menstrual cycle with interval of 24-35 days and duration of 2-7 days&#xD;
                  (premenopausal arm).&#xD;
&#xD;
               3. No oral hormone therapy for 8 weeks and transdermal or vaginal hormone therapy&#xD;
                  for 4 week prior to the study.&#xD;
&#xD;
               4. Willing to use oral hormone therapy during the study period (postmenopausal women&#xD;
                  only).&#xD;
&#xD;
               5. Willing to abstain from using products (other than study medication) that contain&#xD;
                  estrogen, progestin, or progesterone throughout study participation.&#xD;
&#xD;
               6. Have general good health.&#xD;
&#xD;
               7. Willing to refrain from sexual intercourse for 48 hours before vaginal sample&#xD;
                  collection.&#xD;
&#xD;
               8. Willing to abstain from use of vaginal product 7 days before vaginal sample&#xD;
                  collection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  To participate in the study, a subject must NOT&#xD;
&#xD;
               1. Be allergic to estrogen or progesterone products&#xD;
&#xD;
               2. Have active genital infection or inflammation based on vaginal wet preparation,&#xD;
                  power of hydrogen (pH), whiff test and potassium hydroxide (KOH) preparation 2.1&#xD;
                  Vulvovaginal candidiasis, trichomonas vaginitis or bacterial vaginitis 2.2&#xD;
                  Sexually transmitted diseases including herpes simplex viral infection, gonorrhea&#xD;
                  and Chlamydia&#xD;
&#xD;
               3. Have a known contraindication for oral hormone therapy or allergy to use of&#xD;
                  estradiol and/or progesterone&#xD;
&#xD;
               4. Have used estrogen alone or estrogen/progestin for any of the following time&#xD;
                  periods:&#xD;
&#xD;
                  4.1 Vaginal hormone products (ring, cream, gels) within 30 days prior to&#xD;
                  screening 4.2 Transdermal estrogen alone or estrogen/progestin products within 4&#xD;
                  weeks prior to screening 4.3 Oral estrogen and/or progestin therapy within 8&#xD;
                  weeks prior to screening 4.4 Progestational implants, estrogen or&#xD;
                  estrogen/progestational injectable drug therapy within 3 months prior to&#xD;
                  screening 4.5 Estrogen pellet therapy or progestational injectable drug therapy&#xD;
                  within 6 months prior to screening 4.6 Percutaneous estrogen lotions/gels within&#xD;
                  4 weeks prior to screening&#xD;
&#xD;
               5. Have used tamoxifen, raloxifene or other selective estrogen receptor modulators&#xD;
                  (SERMs) therapy within 8 weeks prior to screening&#xD;
&#xD;
               6. Have used an intrauterine device (IUD) within 8 weeks prior to screening&#xD;
&#xD;
               7. Have used vaginal products (pessary, tampon, tablets, douching) within 7 days&#xD;
                  prior to screening&#xD;
&#xD;
               8. Have evidence of cervical, vaginal, or vulvar intraepithelial neoplasia or cancer&#xD;
&#xD;
               9. Have a past or current history breast cancer, endometrial cancer or endometrial&#xD;
                  hyperplasia, hypertriglyceridemia or venous thromboembolism&#xD;
&#xD;
              10. Be an immuno-compromised patient including those with human immunodeficiency&#xD;
                  viral infection, chronic glucocorticoid use or active treatment with&#xD;
                  immunosuppressive agents&#xD;
&#xD;
              11. Have a history of or current evidence of thromboembolism&#xD;
&#xD;
              12. Have evidence of uncontrolled Hypertension Blood pressure &gt;140/100 mmHg&#xD;
&#xD;
              13. Have confirmed Diabetes Mellitus&#xD;
&#xD;
              14. Currently smoking&#xD;
&#xD;
              15. For sexually active premenopausal women, should be protected against pregnancy by&#xD;
                  sterilization, condom use, abstinence, or same sex relationship&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David F Archer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Eastern Virginia Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>David Archer, MD</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>December 6, 2019</results_first_submitted>
  <results_first_submitted_qc>March 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 19, 2020</results_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Eastern Virginia Medical School</investigator_affiliation>
    <investigator_full_name>Intira Sriprasert</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>vaginal cytokine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 4, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02224313/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>1.Premenopausal Women</title>
          <description>Premenopausal women with no treatment assigned</description>
        </group>
        <group group_id="P2">
          <title>2.Postmenopausal Women With Hormones</title>
          <description>Oral hormone therapy will be given to women in this group. Daily dose of oral &quot;estradiol&quot; 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral &quot;estradiol&quot; 1 mg and &quot;progesterone&quot; 100 mg for 14 days will be given during the following 14 days.&#xD;
oral estradiol 1.0 mg: one tablet of oral estradiol 1.0 mg once a day for 28 days&#xD;
oral progesterone 100 mg: one tablet of oral progesterone 100 mg once a day for 14 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Premenopausal Women</title>
          <description>Premenopausal women at baseline</description>
        </group>
        <group group_id="B2">
          <title>Postmenopausal Women</title>
          <description>Postmenopausal women at baseline</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.90" spread="5.11"/>
                    <measurement group_id="B2" value="56.44" spread="3.57"/>
                    <measurement group_id="B3" value="44.17" spread="4.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Women</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.06" spread="5.82"/>
                    <measurement group_id="B2" value="29.97" spread="6.71"/>
                    <measurement group_id="B3" value="30.02" spread="6.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vaginal power of hydrogen (pH)</title>
          <units>pH</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.08" spread="0.17"/>
                    <measurement group_id="B2" value="6.33" spread="0.79"/>
                    <measurement group_id="B3" value="5.21" spread="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Vaginal Cytokines at Baseline</title>
        <description>Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.</description>
        <time_frame>At baseline visit</time_frame>
        <population>One postmenopausal women was excluded due to non-compliance of assigned intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Premenopausal Women</title>
            <description>Premenopausal women in the study</description>
          </group>
          <group group_id="O2">
            <title>Postmenopausal Women</title>
            <description>Postmenopausal women in the study</description>
          </group>
        </group_list>
        <measure>
          <title>Vaginal Cytokines at Baseline</title>
          <description>Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.</description>
          <population>One postmenopausal women was excluded due to non-compliance of assigned intervention.</population>
          <units>pg/ug protein</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL-8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" spread="3.67"/>
                    <measurement group_id="O2" value="3.19" spread="3.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1β</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.24"/>
                    <measurement group_id="O2" value="0.04" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vaginal Cytokines During Follow-up</title>
        <description>Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women.</description>
        <time_frame>At 14 days and 28 days follow-up</time_frame>
        <population>Three premenopausal women were excluded due to missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Premenopausal Women</title>
            <description>Premenopausal women in the study</description>
          </group>
          <group group_id="O2">
            <title>Postmenopausal Women</title>
            <description>Postmenopausal women in the study</description>
          </group>
        </group_list>
        <measure>
          <title>Vaginal Cytokines During Follow-up</title>
          <description>Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women.</description>
          <population>Three premenopausal women were excluded due to missing data.</population>
          <units>pg/ug protein</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL-8 at 14 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.92" spread="1.40"/>
                    <measurement group_id="O2" value="1.34" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1B at 14 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.03"/>
                    <measurement group_id="O2" value="0.04" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8 at 28 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="0.33"/>
                    <measurement group_id="O2" value="1.69" spread="1.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1B at 28 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.02"/>
                    <measurement group_id="O2" value="0.03" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>We evaluated the adverse event at 14 days and 28 days follow-up visits.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Premenopausal Women</title>
          <description>Premenopausal women in the study</description>
        </group>
        <group group_id="E2">
          <title>Postmenopausal Women</title>
          <description>Postmenopausal women in the study</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Several limitations of this study were the small sample size and limited follow-up time, which limited the power to detect statistical significance in some outcomes.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr.David Archer</name_or_title>
      <organization>Eastern Virginia Medical School</organization>
      <phone>7574467444</phone>
      <email>archerdf@evms.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02224313
org study id: CRC-VgCy
nct id: NCT02224313
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare the vaginal health between premenopausal and
      postmenopausal women before and after using oral "estradiol" for 14 days then "estradiol" and
      "progesterone" for 14 days.
This research project recruits 10 healthy, premenopausal women (aged 20-40 years-old) with
      regular menstrual cycle with interval of 24-35 days and duration of 2-7 days and 10 healthy
      postmenopausal women (aged 45-60 years-old) with an intact uterus and at least 12 months but
      not more than 36 months of spontaneous amenorrhea.

      Premenopausal women will not receive any study medication(s). Postmenopausal women will be
      assigned the intervention described below.

      • Oral "estradiol" 1.0 mg tablet for 14 days, then oral "estradiol" 1.0 mg tablet and
      "progesterone" 100 mg capsule for 14 days
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Vaginal Cytokines at Baseline
time frame: At baseline visit
description: Determine the differences in vaginal cytokines: interleukin (IL)-1β and IL-8 between premenopausal and postmenopausal women.
measure: Vaginal Cytokines During Follow-up
time frame: At 14 days and 28 days follow-up
description: Determine the changes in vaginal cytokines in postmenopausal women following treatment with estradiol then estradiol and progesterone compared to the normal menstrual cycle changes in young premenopausal women.
arm group label: 1.Premenopausal women
arm group type: No Intervention
description: No treatment
arm group label: 2.Postmenopausal women with hormones
arm group type: Experimental
description: Oral hormone therapy will be given to women in this group. Daily dose of oral "estradiol" 1 mg will be given the first 14 days after enrollment. Then a daily dose of oral "estradiol" 1 mg and "progesterone" 100 mg for 14 days will be given during the following 14 days.
intervention type: Drug
intervention name: oral estradiol 1.0 mg
description: one tablet of oral estradiol 1.0 mg once a day for 28 days
arm group label: 2.Postmenopausal women with hormones
other name: Estrace
intervention type: Drug
intervention name: oral progesterone 100 mg
description: one tablet of oral progesterone 100 mg once a day for 14 days
arm group label: 2.Postmenopausal women with hormones
other name: Prometrium
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David F Archer, MD
role: Study Director
affiliation: Eastern Virginia Medical School
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Eastern Virginia Medical School
investigator full name: Intira Sriprasert
investigator title: Dr.
mesh term: Estradiol
mesh term: Progesterone
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Several limitations of this study were the small sample size and limited follow-up time, which limited the power to detect statistical significance in some outcomes.
point of contact: 