<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/NCT03789123</url>
  </required_header>
  <id_info>
    <org_study_id>2018.11.1.01.082.r1.101</org_study_id>
    <nct_id>NCT03789123</nct_id>
  </id_info>
  <brief_title>Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma</brief_title>
  <official_title>Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bagcilar Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kocaeli Derince Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Suleymaniye Birth And Women's Health Education And Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bagcilar Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in&#xD;
      endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit&#xD;
      neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix&#xD;
      metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the&#xD;
      estrogen-progesterone combination is mainly based on the inhibition of ovulation,&#xD;
      decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known&#xD;
      that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more&#xD;
      potent. Based on this, the investigators hypothesized that estrogen added to progesterone&#xD;
      could lead to a further reduction in endometrioma size by various mechanisms which probably&#xD;
      include the increased progesterone sensitivity in endometriosis. In addition, the&#xD;
      investigators hypothesized that this therapy can alleviate the destructive effect of&#xD;
      endometriomas on the ovarian reserve.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ovarian reserve</measure>
    <time_frame>up to 24 months</time_frame>
    <description>The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endometrioma Size</measure>
    <time_frame>up to 24 months</time_frame>
    <description>The investigators evaluate endometrioma size (centimeter) using ultrasonography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score</measure>
    <time_frame>up to 24 months</time_frame>
    <description>Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">710</enrollment>
  <condition>Ovarian Reserve</condition>
  <arm_group>
    <arm_group_label>Study Group (patients with OMA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I) Untreated patients (n=142)&#xD;
II) Dienogest (n=142)&#xD;
III) Dienogest/Estradiol valerate+Dienogest (n=142)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group(patients without OMA)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>I) Untreated patients (n=142)&#xD;
II) Dienogest/Estradiol valerate+Dienogest (n=142)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Estradiol valerate/dienogest</intervention_name>
    <description>The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.</description>
    <arm_group_label>Control Group(patients without OMA)</arm_group_label>
    <arm_group_label>Study Group (patients with OMA)</arm_group_label>
    <other_name>Dienogest</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age,&#xD;
             without surgical indication at the time of diagnosis, occasionally and intermittently&#xD;
             controlled pain with NSAIDs or no pain symptom&#xD;
&#xD;
          2. Control Group: Patients with reproductive age without any ovarian cysts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake&#xD;
             that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous&#xD;
             ovarian surgery, AMH levels under 2 ng/ml.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Engin Oral, Prof.Dr. M.D</last_name>
    <role>Study Director</role>
    <affiliation>Istanbul University Cerrahpasa Medical Faculty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tolga Karacan, M.D</last_name>
    <phone>05303638765</phone>
    <email>tolgakaracan84@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tolga Karacan</name>
      <address>
        <city>İstanbul</city>
        <state>Bagcilar</state>
        <zip>34100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tolga Karacan, M.D</last_name>
      <phone>5303638765</phone>
      <email>tolgakaracan84@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Gulfem Basol, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fatma V Ferit, Prof.Dr.M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eser Ozyurek, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometrioma</keyword>
  <keyword>Estradiol valerate + dienogest</keyword>
  <keyword>Dienogest</keyword>
  <keyword>Ovarian reserve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dienogest</mesh_term>
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</mesh_term>
    <mesh_term>Nandrolone</mesh_term>
  </intervention_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/NCT03789123
org study id: 2018.11.1.01.082.r1.101
nct id: NCT03789123
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in
      endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit
      neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix
      metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the
      estrogen-progesterone combination is mainly based on the inhibition of ovulation,
      decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known
      that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more
      potent. Based on this, the investigators hypothesized that estrogen added to progesterone
      could lead to a further reduction in endometrioma size by various mechanisms which probably
      include the increased progesterone sensitivity in endometriosis. In addition, the
      investigators hypothesized that this therapy can alleviate the destructive effect of
      endometriomas on the ovarian reserve.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Ovarian reserve
time frame: up to 24 months
description: The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.
measure: Endometrioma Size
time frame: up to 24 months
description: The investigators evaluate endometrioma size (centimeter) using ultrasonography.
measure: Pain Score
time frame: up to 24 months
description: Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.
arm group label: Study Group (patients with OMA)
arm group type: Experimental
description: I) Untreated patients (n=142)
II) Dienogest (n=142)
III) Dienogest/Estradiol valerate+Dienogest (n=142)
arm group label: Control Group(patients without OMA)
arm group type: Sham Comparator
description: I) Untreated patients (n=142)
II) Dienogest/Estradiol valerate+Dienogest (n=142)
intervention type: Drug
intervention name: Estradiol valerate/dienogest
description: The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.
arm group label: Control Group(patients without OMA)
arm group label: Study Group (patients with OMA)
other name: Dienogest
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Engin Oral, Prof.Dr. M.D
role: Study Director
affiliation: Istanbul University Cerrahpasa Medical Faculty
last name: Tolga Karacan, M.D
phone: 05303638765
email: tolgakaracan84@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Turkey
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Dienogest
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Estradiol
mesh term: Polyestradiol phosphate
mesh term: Nandrolone
sharing ipd: Undecided