<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/NCT02237131</url>
  </required_header>
  <id_info>
    <org_study_id>NV04042013</org_study_id>
    <nct_id>NCT02237131</nct_id>
  </id_info>
  <brief_title>Continuous Versus Cyclic Oral Contraceptives for Endometriosis</brief_title>
  <official_title>Continuous Versus Cyclic Use of Oral Contraceptives Following Surgery for Symptomatic Endometriosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Athens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Athens</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual&#xD;
      cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas&#xD;
      following fertility-sparing surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be&#xD;
      administered. One tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or&#xD;
      one tablet a day in a continuous fashion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2014</start_date>
  <completion_date type="Anticipated">December 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic pain</measure>
    <time_frame>6 months</time_frame>
    <description>In each visit patients will complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of pelvic pain (scoring of pelvic pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>recurrence rate for endometrioma</measure>
    <time_frame>6 months</time_frame>
    <description>Physical and transvaginal sonographic examination</description>
  </secondary_outcome>
  <other_outcome>
    <measure>dysmenorrhea</measure>
    <time_frame>6 months</time_frame>
    <description>In each visit patients were asked to complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of dysmenorrhea (scoring of dysmenorrhea)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Dysmenorrhea</condition>
  <condition>Pelvic Pain</condition>
  <condition>Dyspareunia</condition>
  <condition>Endometrioma</condition>
  <arm_group>
    <arm_group_label>Oral contraceptives cyclic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free. The regimen will be repeated for the duration of the trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral contraceptives continuous</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral contraceptives cyclic</intervention_name>
    <description>tables containing Ethinyl estradiol 0.03mg and drospirenone 3mg will be administered in a cyclic fashion 21 days on 7 days off pill for 6 cycles.</description>
    <arm_group_label>Oral contraceptives continuous</arm_group_label>
    <arm_group_label>Oral contraceptives cyclic</arm_group_label>
    <other_name>Yasmin.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral contraceptives continuous</intervention_name>
    <description>Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion.</description>
    <arm_group_label>Oral contraceptives continuous</arm_group_label>
    <arm_group_label>Oral contraceptives cyclic</arm_group_label>
    <other_name>Yasmin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Women of reproductive age with Symptomatic endometriosis following fertility sparing&#xD;
        surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Contraindications of use of oral contraceptives&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nikos Vlahos, AssProfessor</last_name>
    <role>Study Chair</role>
    <affiliation>University of Athens, 2nd Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Olga Triantafyllidou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Athens, 2nd Department of Obstetrics and Gynecology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olga B Triantafyllidou, M.D, Msc</last_name>
    <phone>+306944963506</phone>
    <email>triantafyllidouolga@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Aretaieion Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olga B Triantafyllidou, M.D, Msc</last_name>
      <phone>+306944963506</phone>
      <email>triantafyllidouolga@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Nikos Vlahos, AssProfessor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>March 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Athens</investigator_affiliation>
    <investigator_full_name>Nikos Vlahos</investigator_full_name>
    <investigator_title>M.D, F.A.C.O.G Ass. Professor of Gynecology and Obstetrics</investigator_title>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <keyword>Oral contraceptives</keyword>
  <keyword>Laparoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Dyspareunia</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
    <mesh_term>Dysmenorrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contraceptive Agents</mesh_term>
    <mesh_term>Contraceptives, Oral</mesh_term>
    <mesh_term>Drospirenone and ethinyl estradiol combination</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02237131
org study id: NV04042013
nct id: NCT02237131
lead sponsor: 
has dmc: Yes
To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual
      cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas
      following fertility-sparing surgery.
Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be
      administered. One tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or
      one tablet a day in a continuous fashion.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Pelvic pain
time frame: 6 months
description: In each visit patients will complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of pelvic pain (scoring of pelvic pain)
measure: recurrence rate for endometrioma
time frame: 6 months
description: Physical and transvaginal sonographic examination
measure: dysmenorrhea
time frame: 6 months
description: In each visit patients were asked to complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of dysmenorrhea (scoring of dysmenorrhea)
arm group label: Oral contraceptives cyclic
arm group type: Experimental
description: Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free. The regimen will be repeated for the duration of the trial.
arm group label: Oral contraceptives continuous
arm group type: Active Comparator
description: Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial.
intervention type: Drug
intervention name: Oral contraceptives cyclic
description: tables containing Ethinyl estradiol 0.03mg and drospirenone 3mg will be administered in a cyclic fashion 21 days on 7 days off pill for 6 cycles.
arm group label: Oral contraceptives continuous
arm group label: Oral contraceptives cyclic
other name: Yasmin.
intervention type: Drug
intervention name: Oral contraceptives continuous
description: Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion.
arm group label: Oral contraceptives continuous
arm group label: Oral contraceptives cyclic
other name: Yasmin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Nikos Vlahos, AssProfessor
role: Study Chair
affiliation: University of Athens, 2nd Department of Obstetrics and Gynecology
last name: Olga Triantafyllidou, MD
role: Principal Investigator
affiliation: University of Athens, 2nd Department of Obstetrics and Gynecology
last name: Olga B Triantafyllidou, M.D, Msc
phone: +306944963506
email: triantafyllidouolga@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University of Athens
investigator full name: Nikos Vlahos
investigator title: M.D, F.A.C.O.G Ass. Professor of Gynecology and Obstetrics
mesh term: Endometriosis
mesh term: Dyspareunia
mesh term: Pelvic Pain
mesh term: Dysmenorrhea
mesh term: Contraceptive Agents
mesh term: Contraceptives, Oral
mesh term: Drospirenone and ethinyl estradiol combination