<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/NCT01715025</url>
  </required_header>
  <id_info>
    <org_study_id>R2012-7</org_study_id>
    <nct_id>NCT01715025</nct_id>
  </id_info>
  <brief_title>A New Treatment Option for Heavy Menstrual Bleeding</brief_title>
  <official_title>An Open-labeled Pilot Study to Determine the Efficacy of an E2//Nomegestrol Acetate (E2/NOMAC)Combination Oral Contraceptive (COC) in the Management of Heavy Menstrual Bleeding (HMB)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sydney Centre for Reproductive Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sydney Centre for Reproductive Health Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Women with measured menstrual bleeding &gt;80ml per cycle and no contraindications to combined&#xD;
      oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral&#xD;
      contraceptive for 3 cycles during which they will collect all menstrual blood and send all&#xD;
      used sanitary protection to the laboratory at the University of Sydney for estimation of&#xD;
      blood loss by the alkaline haematin method.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling&#xD;
      HMB in the majority of women without structural pelvic pathology.&#xD;
&#xD;
      Main outcome:&#xD;
&#xD;
      The primary efficacy end-point will be the proportion of women with a reduction of menstrual&#xD;
      blood loss ≥ 50% from baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women will collect menstrual blood for 3 cycles and will be eligible to enter the treatment&#xD;
      phase if in two of the three pre-treatment cycles the measured menstrual blood loss (MBL)is&#xD;
      &gt;80ml. The mean of these baseline MBL measurements will be the comparator for the efficacy&#xD;
      treatment measurement. Iron studies (serum ferritin, Fe and transferrin) will also be&#xD;
      measured pre and post treatment and related to women's assessment of their quality of life&#xD;
      measured on a validated questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>• The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline</measure>
    <time_frame>Baseline to outcome 12weeks</time_frame>
    <description>A single arm open label intervention study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>•• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls</measure>
    <time_frame>•Baseline to endpoint 12 weeks</time_frame>
    <description>Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Menorrhagia</condition>
  <arm_group>
    <arm_group_label>E2/Nomac</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women with demonstrated HMB at baseline will be assigned to 3 cycles of a E2/Nomac combined pill 1 daily for 24 days followed by 1 placebo pill daily for 4 days per cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>E2Nomac</intervention_name>
    <description>Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study</description>
    <arm_group_label>E2/Nomac</arm_group_label>
    <other_name>Zoely</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-50 years having regular menstrual cycles&#xD;
&#xD;
          -  Women willing to collect all sanitary protection for 6 cycles&#xD;
&#xD;
          -  Women with no contraindications to use of combined hormonal contraception&#xD;
&#xD;
          -  Women not using any hormonal contraception or any treatment for HMB&#xD;
&#xD;
          -  Women who have no demonstrable uterine pathology on pelvic ultrasound&#xD;
&#xD;
          -  Women who have demonstrated a menstrual blood loss (MBL) &gt;80mls in 2 of 3 menstrual&#xD;
             periods during the pre-treatment phase will be eligible to enter the treatment phase&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women for whom combined oral contraceptives are contraindicated&#xD;
&#xD;
          -  Women unwilling to collect all sanitary protection for 6 cycles&#xD;
&#xD;
          -  Women using hormonal contraception or any treatment for HMB&#xD;
&#xD;
          -  Women who have demonstrable uterine pathology on pelvic ultrasound&#xD;
&#xD;
          -  Women who have demonstrated a MBL ≤80mls in 2 of 3 consecutive menstrual periods&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edith Weisberg, MB BS MM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sydney Centre for Reproductive Health Research FPNSW</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Edith Weisberg, MB BS MM</last_name>
    <phone>61 2 8752 4342</phone>
    <email>edithw@fpnsw.org.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jane Hangan, RN</last_name>
    <phone>61 409 091 511</phone>
    <email>janeh@fpnsw.org.au</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>SCRHR</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2131</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Edith Weisberg, MB BS MM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <reference>
    <citation>Fraser IS, Romer T, Parke S, Zeun S, Mellinger U, Machlitt A, Jensen JT. Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. Hum Reprod. 2011 Oct;26(10):2698-708. doi: 10.1093/humrep/der224. Epub 2011 Jul 21.</citation>
    <PMID>21784734</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>measured</keyword>
  <keyword>heavy menstrual bleeding</keyword>
  <keyword>combined oral contraceptive</keyword>
  <keyword>alkaline haematin method</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menorrhagia</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>June 15, 2016</submitted>
    <returned>July 29, 2016</returned>
  </pending_results>
  <!-- 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/NCT01715025
org study id: R2012-7
nct id: NCT01715025
lead sponsor: 
collaborator: 
has dmc: No
Women with measured menstrual bleeding >80ml per cycle and no contraindications to combined
      oral contraceptive use will be assigned to an oestradiol/nomegestrol acetate oral
      contraceptive for 3 cycles during which they will collect all menstrual blood and send all
      used sanitary protection to the laboratory at the University of Sydney for estimation of
      blood loss by the alkaline haematin method.

      Hypothesis:

      An estradiol/nomogestrel acetate (E2/NOMAC) combined pill will be effective in controlling
      HMB in the majority of women without structural pelvic pathology.

      Main outcome:

      The primary efficacy end-point will be the proportion of women with a reduction of menstrual
      blood loss ≥ 50% from baseline.
Women will collect menstrual blood for 3 cycles and will be eligible to enter the treatment
      phase if in two of the three pre-treatment cycles the measured menstrual blood loss (MBL)is
      >80ml. The mean of these baseline MBL measurements will be the comparator for the efficacy
      treatment measurement. Iron studies (serum ferritin, Fe and transferrin) will also be
      measured pre and post treatment and related to women's assessment of their quality of life
      measured on a validated questionnaire.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: • The primary efficacy end-point will be the proportion of women with a reduction ≥ 50% from baseline
time frame: Baseline to outcome 12weeks
description: A single arm open label intervention study
measure: •• A secondary efficacy endpoint will be the number and proportion of cycles with a normal blood loss ≤ 80mls
time frame: •Baseline to endpoint 12 weeks
description: Open label single group measuring the efficacy of a combined hormonal contraceptive to restore a normal level of MBL
arm group label: E2/Nomac
arm group type: Experimental
description: Women with demonstrated HMB at baseline will be assigned to 3 cycles of a E2/Nomac combined pill 1 daily for 24 days followed by 1 placebo pill daily for 4 days per cycle.
intervention type: Drug
intervention name: E2Nomac
description: Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
arm group label: E2/Nomac
other name: Zoely
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edith Weisberg, MB BS MM
role: Principal Investigator
affiliation: Sydney Centre for Reproductive Health Research FPNSW
last name: Edith Weisberg, MB BS MM
phone: 61 2 8752 4342
email: edithw@fpnsw.org.au
last name: Jane Hangan, RN
phone: 61 409 091 511
email: janeh@fpnsw.org.au
facility: 
status: Recruiting
investigator: 
country: Australia
citation: Fraser IS, Romer T, Parke S, Zeun S, Mellinger U, Machlitt A, Jensen JT. Effective treatment of heavy and/or prolonged menstrual bleeding with an oral contraceptive containing estradiol valerate and dienogest: a randomized, double-blind Phase III trial. Hum Reprod. 2011 Oct;26(10):2698-708. doi: 10.1093/humrep/der224. Epub 2011 Jul 21.
PMID: 21784734
responsible party type: Sponsor
mesh term: Menorrhagia
mesh term: Hemorrhage
submitted: June 15, 2016
returned: July 29, 2016