<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/NCT03032848</url>
  </required_header>
  <id_info>
    <org_study_id>23286013.7.0000.0096</org_study_id>
    <secondary_id>475.622</secondary_id>
    <nct_id>NCT03032848</nct_id>
  </id_info>
  <brief_title>Vaginal Estrogens Comparative Trial on Pelvic Organ Prolapse Patients</brief_title>
  <official_title>Randomized, Blinded Trial Comparing Vaginal Estrogens on Pelvic Organ Prolapse Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Paraná</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Paraná</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the difference of three vaginal estrogens creams comparative with placebo on&#xD;
      improvement of hormonal cytology, local and systemic climacteric complaints, as well as its&#xD;
      endometrial security.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2013</start_date>
  <completion_date type="Actual">December 26, 2016</completion_date>
  <primary_completion_date type="Actual">December 20, 2016</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the histopathological effects on endometrium after each treatment</measure>
    <time_frame>48 days</time_frame>
    <description>Compare the histopathological results after treatment on each group and among each other</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compare the endometrial thickness measured by ultrassound after each treatment</measure>
    <time_frame>48 days</time_frame>
    <description>Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the changes of maturation index (Meisels Index) after each treatement</measure>
    <time_frame>48 days</time_frame>
    <description>Compare the changes on Meisels Index after each treatment and among each other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the changes on climacteric complaints after each treatment</measure>
    <time_frame>48 days</time_frame>
    <description>Compare the changes on systemic and genital complaints after each treatment, and among each other</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Vaginitis Atropic</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Endometrial Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Conjugated Estrogen Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use of 1 gram per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Promestriene Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use of 1 gram per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Estriol Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use of 1 gram per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaginal Moisturizer Cream</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>use of 1 gram per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conjugated Estrogen</intervention_name>
    <description>use of 1 gram per day</description>
    <arm_group_label>Estriol Group</arm_group_label>
    <arm_group_label>Promestriene Group</arm_group_label>
    <arm_group_label>Vaginal Moisturizer Cream</arm_group_label>
    <other_name>Premarin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Promestriene</intervention_name>
    <description>use of 1 gram per day</description>
    <arm_group_label>Conjugated Estrogen Group</arm_group_label>
    <arm_group_label>Estriol Group</arm_group_label>
    <arm_group_label>Vaginal Moisturizer Cream</arm_group_label>
    <other_name>Colpotrofine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Estriol</intervention_name>
    <description>use of 1 gram per day</description>
    <arm_group_label>Conjugated Estrogen Group</arm_group_label>
    <arm_group_label>Promestriene Group</arm_group_label>
    <arm_group_label>Vaginal Moisturizer Cream</arm_group_label>
    <other_name>Stelle</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vaginal Moisturizer - Cream</intervention_name>
    <description>use of 1 gram per day</description>
    <arm_group_label>Conjugated Estrogen Group</arm_group_label>
    <arm_group_label>Estriol Group</arm_group_label>
    <arm_group_label>Promestriene Group</arm_group_label>
    <other_name>Vagidrat</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  post menopause women&#xD;
&#xD;
          -  normal oncotic cytology and mammogram&#xD;
&#xD;
          -  any grade of pelvic organ prolapse with surgery indication and ultrasound with&#xD;
             endometrium measure less than 5 mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vaginal bleeding&#xD;
&#xD;
          -  hormonal replacement on the past three months&#xD;
&#xD;
          -  renal or hepatic desease&#xD;
&#xD;
          -  porfiria&#xD;
&#xD;
          -  past venous thromboembolism; ulcerated prolapse&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.</citation>
    <PMID>23985562</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>April 29, 2019</last_update_submitted>
  <last_update_submitted_qc>April 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Paraná</investigator_affiliation>
    <investigator_full_name>Elisa Chicareli Pinhat</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginitis</mesh_term>
    <mesh_term>Endometrial Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estrogens</mesh_term>
    <mesh_term>Estrogens, Conjugated (USP)</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03032848
org study id: 23286013.7.0000.0096
secondary id: 475.622
nct id: NCT03032848
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the difference of three vaginal estrogens creams comparative with placebo on
      improvement of hormonal cytology, local and systemic climacteric complaints, as well as its
      endometrial security.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Care Provider, Investigator)
measure: Evaluate the histopathological effects on endometrium after each treatment
time frame: 48 days
description: Compare the histopathological results after treatment on each group and among each other
measure: Compare the endometrial thickness measured by ultrassound after each treatment
time frame: 48 days
description: Compare the endometrial ultrasound measurement before and after treatment in each group, and among each other
measure: Evaluate the changes of maturation index (Meisels Index) after each treatement
time frame: 48 days
description: Compare the changes on Meisels Index after each treatment and among each other
measure: Evaluate the changes on climacteric complaints after each treatment
time frame: 48 days
description: Compare the changes on systemic and genital complaints after each treatment, and among each other
arm group label: Conjugated Estrogen Group
arm group type: Active Comparator
description: use of 1 gram per day
arm group label: Promestriene Group
arm group type: Active Comparator
description: use of 1 gram per day
arm group label: Estriol Group
arm group type: Active Comparator
description: use of 1 gram per day
arm group label: Vaginal Moisturizer Cream
arm group type: Placebo Comparator
description: use of 1 gram per day
intervention type: Drug
intervention name: Conjugated Estrogen
description: use of 1 gram per day
arm group label: Estriol Group
arm group label: Promestriene Group
arm group label: Vaginal Moisturizer Cream
other name: Premarin
intervention type: Drug
intervention name: Promestriene
description: use of 1 gram per day
arm group label: Conjugated Estrogen Group
arm group label: Estriol Group
arm group label: Vaginal Moisturizer Cream
other name: Colpotrofine
intervention type: Drug
intervention name: Estriol
description: use of 1 gram per day
arm group label: Conjugated Estrogen Group
arm group label: Promestriene Group
arm group label: Vaginal Moisturizer Cream
other name: Stelle
intervention type: Drug
intervention name: Vaginal Moisturizer - Cream
description: use of 1 gram per day
arm group label: Conjugated Estrogen Group
arm group label: Estriol Group
arm group label: Promestriene Group
other name: Vagidrat
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
citation: Management of symptomatic vulvovaginal atrophy: 2013 position statement of The North American Menopause Society. Menopause. 2013 Sep;20(9):888-902; quiz 903-4. doi: 10.1097/GME.0b013e3182a122c2.
PMID: 23985562
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Paraná
investigator full name: Elisa Chicareli Pinhat
investigator title: Doctor
mesh term: Vaginitis
mesh term: Endometrial Hyperplasia
mesh term: Hyperplasia
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
mesh term: Estrogens
mesh term: Estrogens, Conjugated (USP)
sharing ipd: Yes