<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/NCT04433897</url>
  </required_header>
  <id_info>
    <org_study_id>EC 2018/0315</org_study_id>
    <nct_id>NCT04433897</nct_id>
  </id_info>
  <brief_title>Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women</brief_title>
  <acronym>HARALD</acronym>
  <official_title>Observing the Effect of Hormonal Replacement Therapy on Nocturia in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>No</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>
      Aim of this study was to observe&#xD;
&#xD;
      The study was adjusted in two parts:&#xD;
&#xD;
      PART 1 is a crossectional study in which the prevalance, risk factors and etiology of&#xD;
      nocturia among postmenopausal women is assessed.&#xD;
&#xD;
      PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies&#xD;
      on nocturia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in nocturnal Frequency</measure>
    <time_frame>6 months after initiating therapy</time_frame>
    <description>Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in bother linked with nocturnal frequency</measure>
    <time_frame>6 months</time_frame>
    <description>Change in VAS scale of bother linked with nocturnal frequency</description>
  </secondary_outcome>
  <number_of_groups>10</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Nocturia</condition>
  <arm_group>
    <arm_group_label>Oral estrogen + IUD</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral estrogen + hysterectomy</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral estrogen + oral progesterone</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transdermal estrogen + IUD</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transdermal estrogen + hysterectomy</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transdermal estrogen + oral progesteron</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SERM</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using SERM's</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aromatase inhibitor</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Duavive</arm_group_label>
    <description>Women who opt to be treated for their postmenopausal symptoms using duavive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <description>Women who opt not to be treated for their postmenopausal symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>All women fulfilled 3 questionairres&#xD;
TANGO&#xD;
ICIQ -N&#xD;
Perceived Stress Scale</description>
    <arm_group_label>Aromatase inhibitor</arm_group_label>
    <arm_group_label>Duavive</arm_group_label>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_label>Oral estrogen + IUD</arm_group_label>
    <arm_group_label>Oral estrogen + hysterectomy</arm_group_label>
    <arm_group_label>Oral estrogen + oral progesterone</arm_group_label>
    <arm_group_label>SERM</arm_group_label>
    <arm_group_label>Transdermal estrogen + IUD</arm_group_label>
    <arm_group_label>Transdermal estrogen + hysterectomy</arm_group_label>
    <arm_group_label>Transdermal estrogen + oral progesteron</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women who are biochochemically confirmed to be postmenopausal.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with postmenopausal symptoms (hot flushes, atrophy, ..)&#xD;
&#xD;
          -  All women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'Stages&#xD;
             of Reproductive Aging Workshop' (STRAW) criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intake of HRT on the moment of inclusion&#xD;
&#xD;
          -  women with thyroid dysfunction&#xD;
&#xD;
          -  women using antihypertensive agents&#xD;
&#xD;
          -  women with a history of psychiatric or neurological disorders&#xD;
&#xD;
          -  women with a history of alcohol or drug addiction.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Study is specific for postmenopausal women</gender_description>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kim Pauwaert</last_name>
    <phone>093321182</phone>
    <email>kim.pauwaert@ugent.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karel Everaert</last_name>
    <email>Karel.Everaert@uzgent.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Urology, Ghent University</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kim Pauwaert, MD</last_name>
      <phone>+32 93321182</phone>
      <email>kim.pauwaert@uzgent.be</email>
    </contact>
    <contact_backup>
      <last_name>An-Sofie Goessaert, MD, PhD</last_name>
    </contact_backup>
    <investigator>
      <last_name>Kim Pauwaert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>An-Sofie Goessaert, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Karel Everaert, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nocturia</mesh_term>
  </condition_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/NCT04433897
org study id: EC 2018/0315
nct id: NCT04433897
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of this study was to observe

      The study was adjusted in two parts:

      PART 1 is a crossectional study in which the prevalance, risk factors and etiology of
      nocturia among postmenopausal women is assessed.

      PART 2 is a cohort study observing the impact of 10 different hormonal substitution therapies
      on nocturia.
observational model: Cohort
time perspective: Prospective
measure: Change in nocturnal Frequency
time frame: 6 months after initiating therapy
description: Change from baseline in nocturnal voiding episodes assessed via nycturia and menopause questionnaire
measure: Change in bother linked with nocturnal frequency
time frame: 6 months
description: Change in VAS scale of bother linked with nocturnal frequency
arm group label: Oral estrogen + IUD
description: Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + IUD
arm group label: Oral estrogen + hysterectomy
description: Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + hysterectomy.
arm group label: Oral estrogen + oral progesterone
description: Women who opt to be treated for their postmenopausal symptoms using Oral estrogen + oral progesterone.
arm group label: Transdermal estrogen + IUD
description: Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + IUD.
arm group label: Transdermal estrogen + hysterectomy
description: Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + hysterectomy.
arm group label: Transdermal estrogen + oral progesteron
description: Women who opt to be treated for their postmenopausal symptoms using transdermal estrogen + oral progesteron
arm group label: SERM
description: Women who opt to be treated for their postmenopausal symptoms using SERM's
arm group label: Aromatase inhibitor
description: Women who opt to be treated for their postmenopausal symptoms using aromatase inhibitor.
arm group label: Duavive
description: Women who opt to be treated for their postmenopausal symptoms using duavive.
arm group label: No treatment
description: Women who opt not to be treated for their postmenopausal symptoms.
intervention type: Other
intervention name: Questionnaire
description: All women fulfilled 3 questionairres
TANGO
ICIQ -N
Perceived Stress Scale
arm group label: Aromatase inhibitor
arm group label: Duavive
arm group label: No treatment
arm group label: Oral estrogen + IUD
arm group label: Oral estrogen + hysterectomy
arm group label: Oral estrogen + oral progesterone
arm group label: SERM
arm group label: Transdermal estrogen + IUD
arm group label: Transdermal estrogen + hysterectomy
arm group label: Transdermal estrogen + oral progesteron
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Study is specific for postmenopausal women
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kim Pauwaert
phone: 093321182
email: kim.pauwaert@ugent.be
last name: Karel Everaert
email: Karel.Everaert@uzgent.be
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Belgium
responsible party type: Sponsor
mesh term: Nocturia
sharing ipd: Undecided