<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/NCT01712763</url>
  </required_header>
  <id_info>
    <org_study_id>C06/2012</org_study_id>
    <nct_id>NCT01712763</nct_id>
  </id_info>
  <brief_title>Degarelix in the Treatment of Endometriosis Recurrence</brief_title>
  <official_title>Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Endocrinology and Reproductive Medicine, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Endocrinology and Reproductive Medicine, Italy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The long acting GnRH antagonist degarelix will be tested for the treatment of women with&#xD;
      endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom&#xD;
      disappearance and disease free time during follow-up will be the outcomes for establishing&#xD;
      which medical treatment is the best in endometriosis recurrence treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing&#xD;
      recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH&#xD;
      antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist&#xD;
      and strongly suppress LH secretion and thecal cell activity may show a better effects on&#xD;
      endometrial implants than GnRH agonist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 3</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease free time</measure>
    <time_frame>24 months</time_frame>
    <description>time without pain symptoms due to the disease recurrence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time of disappearance pain</measure>
    <time_frame>24 months</time_frame>
    <description>time needed during treatment to improve the pain symptoms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>reduction of endometriosis lesions</measure>
    <time_frame>24 months</time_frame>
    <description>endometriosis lesions regression during treatment evidenced by MRI scan</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">360</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Degarelix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>180 women will be treated with degarelix 80mg in one administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Goserelin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>180 women will be treated with goserelin 3.6mg monthly for three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>degarelix</intervention_name>
    <description>180 women will be treated with degarlix 80 mg, in only one administration covering three months</description>
    <arm_group_label>Degarelix</arm_group_label>
    <other_name>firmagon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>goserelin</intervention_name>
    <description>180 women will be treated with decapeptyl 3.6 every month for three months</description>
    <arm_group_label>Goserelin</arm_group_label>
    <other_name>decapeptyl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women affected by endometriosis showing recurrence of pain symptoms&#xD;
&#xD;
          -  previous surgery for endometriosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of other systemic diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARCO SBRACIA, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Centre for Endocrinology and Reproductive Medicine, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albania Spitali Amerikan</name>
      <address>
        <city>Tirana</city>
        <country>Albania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nadezda Women's Health Hospital</name>
      <address>
        <city>Sofia</city>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cerm-Hungaria</name>
      <address>
        <city>Rome</city>
        <zip>00153</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Albania</country>
    <country>Bulgaria</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>February 10, 2022</last_update_submitted>
  <last_update_submitted_qc>February 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <keyword>long acting GnRH antagonist</keyword>
  <keyword>Degarelix</keyword>
  <keyword>Recurrence</keyword>
  <keyword>Pelvic Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Goserelin</mesh_term>
    <mesh_term>Triptorelin Pamoate</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/NCT01712763
org study id: C06/2012
nct id: NCT01712763
lead sponsor: 
has dmc: Yes
The long acting GnRH antagonist degarelix will be tested for the treatment of women with
      endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom
      disappearance and disease free time during follow-up will be the outcomes for establishing
      which medical treatment is the best in endometriosis recurrence treatment.
Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing
      recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH
      antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist
      and strongly suppress LH secretion and thecal cell activity may show a better effects on
      endometrial implants than GnRH agonist.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: disease free time
time frame: 24 months
description: time without pain symptoms due to the disease recurrence
measure: time of disappearance pain
time frame: 24 months
description: time needed during treatment to improve the pain symptoms
measure: reduction of endometriosis lesions
time frame: 24 months
description: endometriosis lesions regression during treatment evidenced by MRI scan
arm group label: Degarelix
arm group type: Experimental
description: 180 women will be treated with degarelix 80mg in one administration
arm group label: Goserelin
arm group type: Active Comparator
description: 180 women will be treated with goserelin 3.6mg monthly for three months
intervention type: Drug
intervention name: degarelix
description: 180 women will be treated with degarlix 80 mg, in only one administration covering three months
arm group label: Degarelix
other name: firmagon
intervention type: Drug
intervention name: goserelin
description: 180 women will be treated with decapeptyl 3.6 every month for three months
arm group label: Goserelin
other name: decapeptyl
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: MARCO SBRACIA, MD
role: Study Chair
affiliation: Centre for Endocrinology and Reproductive Medicine, Italy
facility: 
facility: 
facility: 
country: Albania
country: Bulgaria
country: Italy
responsible party type: Sponsor
mesh term: Endometriosis
mesh term: Recurrence
mesh term: Goserelin
mesh term: Triptorelin Pamoate