<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/NCT03264781</url>
  </required_header>
  <id_info>
    <org_study_id>OBCU</org_study_id>
    <nct_id>NCT03264781</nct_id>
  </id_info>
  <brief_title>The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users</brief_title>
  <official_title>The Effect of Cyclofem® for the Treatment of Irregular Uterine Bleeding in Implant Contraceptive Users; a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine that once-a-month injectable contraceptive(&#xD;
      Cyclofem® ) has the effect on treatment of irregular uterine bleeding in implant&#xD;
      contraceptive users or not.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stratified randomization Implanon and Jadelle group were done using block randomization. The&#xD;
      participants and investigators were blinded to treatment allocation, using drug coding that&#xD;
      not revealed until the end of study. Research assistants and nurse who did not have involve&#xD;
      in analyses data would follow the recruitment criteria and drug injection follow the code of&#xD;
      drug.&#xD;
&#xD;
      All participants were collected demographic data, medical history, obstetrical and&#xD;
      gynecological history, bleeding pattern before enrollment. Then physical exam and pelvic&#xD;
      examination were performed for all participants. Participants received single dose&#xD;
      intramuscular injection of Cyclofem® 0.5 ml or normal saline 0.5 ml as placebo on that day of&#xD;
      recruitment to the study. Daily record of bleeding, spotting and side effect was done on&#xD;
      record form.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo</measure>
    <time_frame>12 weeks</time_frame>
    <description>Menstrual record chart was using to record bleeding/spotting days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of days that bleeding stopped between Cyclofem® and placebo for the treatment of irregular uterine bleeding in implant contraceptive users</measure>
    <time_frame>12 weeks</time_frame>
    <description>Menstrual record chart was using to record bleeding/spotting days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users</measure>
    <time_frame>12 weeks</time_frame>
    <description>Questionnaire was using to record adverse effect during follow up period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Uterine Bleeding</condition>
  <arm_group>
    <arm_group_label>Cyclofem group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal saline 0.5 ml IM single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclofem</intervention_name>
    <description>Intramuscularly injection 0.5 ml of Cyclofem or placebo</description>
    <arm_group_label>Cyclofem group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Questionnaire and Menstrual record chart</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Implant (Jadelle or Implanon) inserted before enrollment with the symptom of bleeding&#xD;
             disturbances for eight or more continuous days or a current bleeding-free interval of&#xD;
             15 days or less&#xD;
&#xD;
          -  Regular menstruation at least 1 cycle before the usage of implant contraceptive&#xD;
&#xD;
          -  Willingness to participate in a placebo-controlled study and ability to keep an&#xD;
             accurate daily menstrual record&#xD;
&#xD;
          -  No gynecological or serious medical diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to estrogen or progesterone use such as&#xD;
&#xD;
               -  breast cancer&#xD;
&#xD;
               -  Liver cancer or tumor&#xD;
&#xD;
               -  Uncontrolled blood pressure (BP ≥160/100 mmHg )&#xD;
&#xD;
               -  History of atherosclerosis, vascular disease and high risk for VIE&#xD;
&#xD;
               -  History of ischemic stroke&#xD;
&#xD;
               -  Coagulopathy&#xD;
&#xD;
               -  Uncontrolled diabetes mellitus and complication&#xD;
&#xD;
               -  Cirrhosis&#xD;
&#xD;
               -  SLE with antiphospholipid positive&#xD;
&#xD;
               -  History of migraine with aura or age of 35 years old or more than with history of&#xD;
                  migraine non-aura&#xD;
&#xD;
               -  Age of 35 years old or more than with history of smoking more than 15 cigarettes&#xD;
                  per day&#xD;
&#xD;
               -  Postpartum 6 weeks&#xD;
&#xD;
               -  Plan for surgery procedure that need immobilization after surgery&#xD;
&#xD;
          -  Previous treatment for 3 months before enrollment&#xD;
&#xD;
          -  Allergic to drug component of Cyclofem® ( Medroxyprogesterone acetate , Estradiol&#xD;
             cypionate)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nitisa Tapanwong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nitisa Tapanwong, MD</last_name>
    <phone>066817931684</phone>
    <email>nitisa.tapanwong@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chulalongkorn Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nitisa Tapanwong, MD</last_name>
      <email>nitisa.tapanwong@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>June 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cyclofem®</keyword>
  <keyword>Implant</keyword>
  <keyword>Jadelle</keyword>
  <keyword>Implanon</keyword>
  <keyword>irregular uterine bleeding</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>CycloProvera</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/NCT03264781
org study id: OBCU
nct id: NCT03264781
lead sponsor: 
The purpose of this study is to determine that once-a-month injectable contraceptive(
      Cyclofem® ) has the effect on treatment of irregular uterine bleeding in implant
      contraceptive users or not.
Stratified randomization Implanon and Jadelle group were done using block randomization. The
      participants and investigators were blinded to treatment allocation, using drug coding that
      not revealed until the end of study. Research assistants and nurse who did not have involve
      in analyses data would follow the recruitment criteria and drug injection follow the code of
      drug.

      All participants were collected demographic data, medical history, obstetrical and
      gynecological history, bleeding pattern before enrollment. Then physical exam and pelvic
      examination were performed for all participants. Participants received single dose
      intramuscular injection of Cyclofem® 0.5 ml or normal saline 0.5 ml as placebo on that day of
      recruitment to the study. Daily record of bleeding, spotting and side effect was done on
      record form.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Proportion of subjects that bleeding stopped after treatment with Cyclofem or placebo
time frame: 12 weeks
description: Menstrual record chart was using to record bleeding/spotting days
measure: Number of days that bleeding stopped between Cyclofem® and placebo for the treatment of irregular uterine bleeding in implant contraceptive users
time frame: 12 weeks
description: Menstrual record chart was using to record bleeding/spotting days
measure: Side effect of Cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users
time frame: 12 weeks
description: Questionnaire was using to record adverse effect during follow up period
arm group label: Cyclofem group
arm group type: Experimental
description: Medroxyprogesterone Acetate 25 mg plus Estradiol Cypionate 5 mg (Cyclofem®) 0.5 ml IM injection single dose
arm group label: Placebo group
arm group type: Placebo Comparator
description: normal saline 0.5 ml IM single dose
intervention type: Drug
intervention name: Cyclofem
description: Intramuscularly injection 0.5 ml of Cyclofem or placebo
arm group label: Cyclofem group
arm group label: Placebo group
other name: Questionnaire and Menstrual record chart
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nitisa Tapanwong, MD
role: Principal Investigator
affiliation: Department of Obstetrics and Gynecology of King Chulalongkorn Memorial Hospital
last name: Nitisa Tapanwong, MD
phone: 066817931684
email: nitisa.tapanwong@gmail.com
facility: 
status: Recruiting
contact: 
country: Thailand
responsible party type: Sponsor
mesh term: Uterine Hemorrhage
mesh term: Hemorrhage
mesh term: CycloProvera
sharing ipd: No