<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/NCT03033160</url>
  </required_header>
  <id_info>
    <org_study_id>052-2015</org_study_id>
    <nct_id>NCT03033160</nct_id>
  </id_info>
  <brief_title>Vaginal Estrogen for Asymptomatic Microscopic Hematuria</brief_title>
  <official_title>A Randomized Controlled Trial of Vaginal Estrogen to Treat Asymptomatic Microscopic Hematuria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Urogynecology Associates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mount Auburn Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Urogynecology Associates</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The specific aim of this protocol is to determine whether vaginal estrogen is an effective&#xD;
      treatment for asymptomatic microscopic hematuria in postmenopausal women. The investigators&#xD;
      hypothesize that women who use vaginal estrogen for three months will be more likely to have&#xD;
      resolution of their asymptomatic microscopic hematuria compared with women who do not use&#xD;
      vaginal estrogen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, randomized controlled trial to evaluate whether vaginal estrogen is&#xD;
      an effective treatment for asymptomatic microscopic hematuria. Postmenopausal women with&#xD;
      asymptomatic microscopic hematuria will be recruited from the two urogynecology clinics that&#xD;
      serve as the clinic sites for the Mount Auburn Hospital/Beth Israel Deaconess Medical Center&#xD;
      Female Pelvic Medicine and Reconstructive Surgery fellowship.&#xD;
&#xD;
      Participants are eligible if they are postmenopausal, defined by amenorrhea for at least one&#xD;
      year or a bilateral oophorectomy at least one year prior, and have three or more red blood&#xD;
      cells per high powered field visible in a properly collected urine specimen without evidence&#xD;
      of infection. In addition, participants must have a negative cystoscopy and computed&#xD;
      tomography urogram (or magnetic resonance urography if history of renal insufficiency or&#xD;
      contrast allergy) within the past three years. Exclusion criteria include any of the&#xD;
      following: current or past thromboembolic disorder or cerebrovascular accident, intolerance&#xD;
      to previous estrogen replacement therapy or hormone replacement therapy, estrogen dependent&#xD;
      neoplasm within the past five years (unless supporting documentation from patient's&#xD;
      oncologist is obtained), estrogen replacement therapy or hormone replacement therapy within&#xD;
      the past three months or selective estrogen receptor modulators within eight weeks of&#xD;
      enrollment, urinary tract infection, urinary calculi, urinary tract malignancy, vaginal&#xD;
      bleeding of unknown origin, urethral caruncle, history of recurrent urinary tract infections&#xD;
      in the last one year, and stage two or greater pelvic organ prolapse.&#xD;
&#xD;
      Participants will be randomized to either an estradiol-releasing vaginal ring (Estring;&#xD;
      Pfizer, New York, NY) or expectant management in a ratio of 1:1 using computer-generated&#xD;
      block randomization stratified by enrollment site.&#xD;
&#xD;
      Estring is a silicone vaginal ring, 5.5 cm in diameter, containing 2 mg of 17-estradiol,&#xD;
      which is released at a rate of 7.5 g daily. The Estring was chosen as the vehicle for vaginal&#xD;
      estrogen secondary to its ease of administration, higher patient preference, acceptability,&#xD;
      and compliance.&#xD;
&#xD;
      After eligibility is confirmed and written, informed consent is obtained, participants will&#xD;
      be randomized to one of the two study arms. Participants randomized to the use of vaginal&#xD;
      estrogen will have the vaginal ring placed by one of the investigators. Participants in both&#xD;
      study arms will complete the short form of the Urogenital Distress Inventory (UDI-6) and the&#xD;
      Incontinence Impact Questionnaire (IIQ-7).&#xD;
&#xD;
      Participants in the vaginal estrogen arm will be called at two, four and eight weeks to&#xD;
      ensure that the Estring is still in place and follow-up appointments will be scheduled as&#xD;
      needed if there is any question as to whether the ring is still in place.&#xD;
&#xD;
      At the 12-week visit all participants will provide a urine sample for urinalysis to assess&#xD;
      whether the microscopic hematuria is present. All participants also will be asked to complete&#xD;
      the UDI-6 and IIQ-7 and vaginal mucosal atrophy will be assessed as described above. Women in&#xD;
      the vaginal estrogen arm will have the Estring removed and a new Estring will be placed by&#xD;
      one of the investigators; participants also will be asked if the ring was removed or fell out&#xD;
      during the past 12 weeks. All participants will be asked whether any of the following, (which&#xD;
      could be a side effect from vaginal estrogen use) occurred in the previous 12 weeks:&#xD;
      dyspareunia for subject or partner, vaginal bleeding, non-physiologic discharge, vaginal&#xD;
      ulceration and vaginal irritation.&#xD;
&#xD;
      participants will be followed for 24 weeks to determine if more than 12 weeks are needed for&#xD;
      resolution.&#xD;
&#xD;
      At the 24-week visit, all participants will provide a urine sample for urinalysis to assess&#xD;
      whether the microscopic hematuria is present. All participants also will be asked to complete&#xD;
      the UDI-6 and IIQ-7 and vaginal mucosal atrophy will be assessed as described above. We will&#xD;
      ask all participants whether any of the following, which could be a side effect from vaginal&#xD;
      estrogen use, occurred in the previous 12 weeks: dyspareunia for subject or their partner,&#xD;
      vaginal bleeding, non-physiologic discharge, vaginal ulceration and vaginal irritation. One&#xD;
      of the investigators will remove the Estring from all women in the vaginal estrogen arm.&#xD;
&#xD;
      At the 24 week visit investigators will offer women in the expectant management arm with&#xD;
      persistent microscopic hematuria the opportunity to try the Estring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of microscopic hematuria (RBC's) at 12 weeks compared to baseline measurement</measure>
    <time_frame>12 weeks</time_frame>
    <description>Investigators will compare red blood cell count results obtained during the initial urinalysis to the 12 week urinalysis to measure any change in red blood cell count (if any).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Microscopic Hematuria (RBC's) at 24 weeks compared to baseline.</measure>
    <time_frame>24 weeks</time_frame>
    <description>Investigators will cimpare red blood cell count results obtained during the initial Urinalysis to the 24 week urinalysis to measure any change in red blood cell count (if any).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To Assess Quality of Life</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measurement of quality of life change from baseline, utilizing subject self administered questionnaires, Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire-short Form (IIQ-7)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Asymptomatic Microscopic Hematuria</condition>
  <arm_group>
    <arm_group_label>Estradiol Ring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Estradiol Ring per vagina every 3 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Observation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Estradiol Ring</intervention_name>
    <arm_group_label>Estradiol Ring</arm_group_label>
    <other_name>Estring</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postmenopausal, defined by amenorrhea for at least one year or a bilateral&#xD;
             oophorectomy at least one year prior, and have three or more red blood cells per high&#xD;
             powered field visible in a properly collected urine specimen without evidence of&#xD;
             infection. In addition, women must have a negative cystoscopy and computed tomography&#xD;
             urogram (or magnetic resonance urography if history of renal insufficiency or contrast&#xD;
             allergy) within the past three years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past thromboembolic disorder or cerebrovascular accident&#xD;
&#xD;
          -  Intolerance to previous estrogen replacement therapy or hormone replacement therapy&#xD;
&#xD;
          -  Estrogen dependent neoplasm within the past five years (unless supporting&#xD;
             documentation from patient's oncologist is obtained)&#xD;
&#xD;
          -  Estrogen replacement therapy or hormone replacement therapy within the past three&#xD;
             months or selective estrogen receptor modulators within eight weeks of enrollment&#xD;
&#xD;
          -  Urinary tract infection&#xD;
&#xD;
          -  Urinary calculi&#xD;
&#xD;
          -  Urinary tract malignancy&#xD;
&#xD;
          -  Vaginal bleeding of unknown origin&#xD;
&#xD;
          -  Urethral caruncle&#xD;
&#xD;
          -  History of recurrent urinary tract infections in the last one year&#xD;
&#xD;
          -  Stage two or greater pelvic organ prolapse.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lekha Hota, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Practitioner</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathleen Rogers</last_name>
    <phone>614-354-5452</phone>
    <email>krogers2@mah.harvard.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mount Auburn Hospital</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02138</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen Rogers</last_name>
      <phone>617-354-5452</phone>
      <email>krogers2@mah.harvard.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Urogynecology Associates</investigator_affiliation>
    <investigator_full_name>Lekha S. Hota</investigator_full_name>
    <investigator_title>Clinical Instructor Division of Urogynecology and Female Pelvic Medicine and Reconstructive Surgery</investigator_title>
  </responsible_party>
  <keyword>Estrogen</keyword>
  <keyword>Hematuria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematuria</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>No</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/NCT03033160
org study id: 052-2015
nct id: NCT03033160
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The specific aim of this protocol is to determine whether vaginal estrogen is an effective
      treatment for asymptomatic microscopic hematuria in postmenopausal women. The investigators
      hypothesize that women who use vaginal estrogen for three months will be more likely to have
      resolution of their asymptomatic microscopic hematuria compared with women who do not use
      vaginal estrogen.
This is a multi-center, randomized controlled trial to evaluate whether vaginal estrogen is
      an effective treatment for asymptomatic microscopic hematuria. Postmenopausal women with
      asymptomatic microscopic hematuria will be recruited from the two urogynecology clinics that
      serve as the clinic sites for the Mount Auburn Hospital/Beth Israel Deaconess Medical Center
      Female Pelvic Medicine and Reconstructive Surgery fellowship.

      Participants are eligible if they are postmenopausal, defined by amenorrhea for at least one
      year or a bilateral oophorectomy at least one year prior, and have three or more red blood
      cells per high powered field visible in a properly collected urine specimen without evidence
      of infection. In addition, participants must have a negative cystoscopy and computed
      tomography urogram (or magnetic resonance urography if history of renal insufficiency or
      contrast allergy) within the past three years. Exclusion criteria include any of the
      following: current or past thromboembolic disorder or cerebrovascular accident, intolerance
      to previous estrogen replacement therapy or hormone replacement therapy, estrogen dependent
      neoplasm within the past five years (unless supporting documentation from patient's
      oncologist is obtained), estrogen replacement therapy or hormone replacement therapy within
      the past three months or selective estrogen receptor modulators within eight weeks of
      enrollment, urinary tract infection, urinary calculi, urinary tract malignancy, vaginal
      bleeding of unknown origin, urethral caruncle, history of recurrent urinary tract infections
      in the last one year, and stage two or greater pelvic organ prolapse.

      Participants will be randomized to either an estradiol-releasing vaginal ring (Estring;
      Pfizer, New York, NY) or expectant management in a ratio of 1:1 using computer-generated
      block randomization stratified by enrollment site.

      Estring is a silicone vaginal ring, 5.5 cm in diameter, containing 2 mg of 17-estradiol,
      which is released at a rate of 7.5 g daily. The Estring was chosen as the vehicle for vaginal
      estrogen secondary to its ease of administration, higher patient preference, acceptability,
      and compliance.

      After eligibility is confirmed and written, informed consent is obtained, participants will
      be randomized to one of the two study arms. Participants randomized to the use of vaginal
      estrogen will have the vaginal ring placed by one of the investigators. Participants in both
      study arms will complete the short form of the Urogenital Distress Inventory (UDI-6) and the
      Incontinence Impact Questionnaire (IIQ-7).

      Participants in the vaginal estrogen arm will be called at two, four and eight weeks to
      ensure that the Estring is still in place and follow-up appointments will be scheduled as
      needed if there is any question as to whether the ring is still in place.

      At the 12-week visit all participants will provide a urine sample for urinalysis to assess
      whether the microscopic hematuria is present. All participants also will be asked to complete
      the UDI-6 and IIQ-7 and vaginal mucosal atrophy will be assessed as described above. Women in
      the vaginal estrogen arm will have the Estring removed and a new Estring will be placed by
      one of the investigators; participants also will be asked if the ring was removed or fell out
      during the past 12 weeks. All participants will be asked whether any of the following, (which
      could be a side effect from vaginal estrogen use) occurred in the previous 12 weeks:
      dyspareunia for subject or partner, vaginal bleeding, non-physiologic discharge, vaginal
      ulceration and vaginal irritation.

      participants will be followed for 24 weeks to determine if more than 12 weeks are needed for
      resolution.

      At the 24-week visit, all participants will provide a urine sample for urinalysis to assess
      whether the microscopic hematuria is present. All participants also will be asked to complete
      the UDI-6 and IIQ-7 and vaginal mucosal atrophy will be assessed as described above. We will
      ask all participants whether any of the following, which could be a side effect from vaginal
      estrogen use, occurred in the previous 12 weeks: dyspareunia for subject or their partner,
      vaginal bleeding, non-physiologic discharge, vaginal ulceration and vaginal irritation. One
      of the investigators will remove the Estring from all women in the vaginal estrogen arm.

      At the 24 week visit investigators will offer women in the expectant management arm with
      persistent microscopic hematuria the opportunity to try the Estring.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Comparison of microscopic hematuria (RBC's) at 12 weeks compared to baseline measurement
time frame: 12 weeks
description: Investigators will compare red blood cell count results obtained during the initial urinalysis to the 12 week urinalysis to measure any change in red blood cell count (if any).
measure: Comparison of Microscopic Hematuria (RBC's) at 24 weeks compared to baseline.
time frame: 24 weeks
description: Investigators will cimpare red blood cell count results obtained during the initial Urinalysis to the 24 week urinalysis to measure any change in red blood cell count (if any).
measure: To Assess Quality of Life
time frame: 12 weeks
description: Measurement of quality of life change from baseline, utilizing subject self administered questionnaires, Urogenital Distress Inventory Short Form (UDI-6) and the Incontinence Impact Questionnaire-short Form (IIQ-7)
arm group label: Estradiol Ring
arm group type: Experimental
description: Estradiol Ring per vagina every 3 months
arm group label: Observation
arm group type: No Intervention
description: Observation
intervention type: Drug
intervention name: Estradiol Ring
arm group label: Estradiol Ring
other name: Estring
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lekha Hota, MD
role: Principal Investigator
affiliation: Practitioner
last name: Kathleen Rogers
phone: 614-354-5452
email: krogers2@mah.harvard.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Urogynecology Associates
investigator full name: Lekha S. Hota
investigator title: Clinical Instructor Division of Urogynecology and Female Pelvic Medicine and Reconstructive Surgery
mesh term: Hematuria
mesh term: Estradiol
sharing ipd: No