<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/NCT02213081</url>
  </required_header>
  <id_info>
    <org_study_id>STU00091840</org_study_id>
    <nct_id>NCT02213081</nct_id>
  </id_info>
  <brief_title>Ulipristal for Endometriosis-related Pelvic Pain</brief_title>
  <official_title>Phase IV Pilot Study of Ulipristal Acetate for Treatment of Endometriosis-related Pelvic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this research is to assess the benefit of a medication (ulipristal) for&#xD;
      alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess the use of a medication to improve symptoms of chronic,&#xD;
      endometriosis-related pelvic pain among women who did no achieve relief with prior surgical&#xD;
      and medical treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Pelvic Pain</measure>
    <time_frame>5 months</time_frame>
    <description>Patients will document self-reported weekly average pelvic pain scores for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vaginal bleeding</measure>
    <time_frame>5 months</time_frame>
    <description>Patients will record the # of tampons or pads they use each week while enrolled in the study (1 month pre-medication, 3 months during medication, 1 month after medication).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain with sexual intercourse</measure>
    <time_frame>5 months</time_frame>
    <description>If sexually active, patients will document self-reported weekly average pelvic pain scores with sexual intercourse for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum hormone levels</measure>
    <time_frame>5 months</time_frame>
    <description>Serum levels of hormones that regulate the menstrual cycle will be assessed one month prior to starting treatment, while receiving treatment for 3 months and at one month subsequent to treatment.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain with bowel movements</measure>
    <time_frame>5 months</time_frame>
    <description>Patients will document self-reported weekly average pelvic pain scores with defecation for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Endometriosis</condition>
  <arm_group>
    <arm_group_label>Ulipristal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 patients with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ulipristal</intervention_name>
    <description>Patients will take 15mg every other day, or every 4 days per week.</description>
    <arm_group_label>Ulipristal</arm_group_label>
    <other_name>Ulipristal Acetate</other_name>
    <other_name>Ella</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of endometriosis with surgical confirmation via laparoscopy performed within&#xD;
             3 years prior to study enrollment&#xD;
&#xD;
          -  English-speaking reproductive-age women (18-50yo) with regular, cyclical menses&#xD;
&#xD;
          -  Treatment-refractory endometriosis, as defined by persistent or recurrent pelvic pain&#xD;
             following one or more treatments involving surgery and/or hormonal treatment&#xD;
&#xD;
          -  Dysmenorrhea and chronic pelvic pain for a least one week out of the month during past&#xD;
             5 months or longer&#xD;
&#xD;
          -  Endometrial biopsy before and after intervention&#xD;
&#xD;
          -  Adequate organ and marrow function as defined below:&#xD;
&#xD;
          -  leukocytes ≥ 3,000/microliter&#xD;
&#xD;
          -  absolute neutrophil count ≥ 1,500/microliter&#xD;
&#xD;
          -  platelets ≥ 100,000/microliter&#xD;
&#xD;
          -  total bilirubin within normal institutional limits&#xD;
&#xD;
          -  Liver function tests ≤ 2.5 X institutional upper limit of normal&#xD;
&#xD;
          -  creatinine within normal institutional limits&#xD;
&#xD;
          -  Women of child-bearing potential must agree to use adequate contraception (hormonal or&#xD;
             barrier method of birth control; abstinence) prior to study entry, for the duration of&#xD;
             study participation, and for 90 days following completion of therapy. Should a woman&#xD;
             become pregnant or suspect she is pregnant while participating in this study, she&#xD;
             should inform her treating physician immediately.&#xD;
&#xD;
          -  A female of child-bearing potential is any woman (regardless of sexual orientation,&#xD;
             having undergone a tubal ligation, or remaining celibate by choice) who meets the&#xD;
             following criteria:&#xD;
&#xD;
          -  Has not undergone a hysterectomy or bilateral oophorectomy; or&#xD;
&#xD;
          -  Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has&#xD;
             had menses at any time in the preceding 12 consecutive months).&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undiagnosed vaginal bleeding&#xD;
&#xD;
          -  Abnormal results from endometrial biopsy&#xD;
&#xD;
          -  Presence of ovarian cysts ≥ 3 cm&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Refusal to adhere the birth control strategy of the study (use of a combination of a&#xD;
             condom and a vaginal sponge during each intercourse while on ulipristal, plus one&#xD;
             month before the onset and one month after the completion of ulipristal therapy)&#xD;
&#xD;
          -  Women taking digoxin, dabigatran or etexilate due to interference of ulipristal&#xD;
             acetate with the concentration of these substances bound by plasma proteins.&#xD;
&#xD;
          -  Women taking moderate to potent inducers of hepatic metabolism (e.g. erythromycin,&#xD;
             ketoconazole, ritonavir, nefazodone).&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to Ulipristal.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             pulmonary, cardiac, renal, hepatic or thromboembolic disease, infection, symptomatic&#xD;
             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serdar Bulun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University, Northwestern Memorial Hopsital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University, Prentice Women's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>September 27, 2016</last_update_submitted>
  <last_update_submitted_qc>September 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Serdar Bulun</investigator_full_name>
    <investigator_title>Chair, Department of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <keyword>chronic pelvic pain</keyword>
  <keyword>dysmenorrhea</keyword>
  <keyword>dyschezia</keyword>
  <keyword>bleeding</keyword>
  <keyword>ulipristal</keyword>
  <keyword>progesterone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ulipristal acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 18, 2019</submitted>
    <returned>May 10, 2019</returned>
    <submitted>September 26, 2022</submitted>
    <returned>October 21, 2022</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/NCT02213081
org study id: STU00091840
nct id: NCT02213081
lead sponsor: 
has dmc: No
The aim of this research is to assess the benefit of a medication (ulipristal) for
      alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.
This study will assess the use of a medication to improve symptoms of chronic,
      endometriosis-related pelvic pain among women who did no achieve relief with prior surgical
      and medical treatments.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pelvic Pain
time frame: 5 months
description: Patients will document self-reported weekly average pelvic pain scores for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.
measure: Vaginal bleeding
time frame: 5 months
description: Patients will record the # of tampons or pads they use each week while enrolled in the study (1 month pre-medication, 3 months during medication, 1 month after medication).
measure: Pain with sexual intercourse
time frame: 5 months
description: If sexually active, patients will document self-reported weekly average pelvic pain scores with sexual intercourse for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.
measure: Serum hormone levels
time frame: 5 months
description: Serum levels of hormones that regulate the menstrual cycle will be assessed one month prior to starting treatment, while receiving treatment for 3 months and at one month subsequent to treatment.
measure: Pain with bowel movements
time frame: 5 months
description: Patients will document self-reported weekly average pelvic pain scores with defecation for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.
arm group label: Ulipristal
arm group type: Experimental
description: 25 patients with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months.
intervention type: Drug
intervention name: Ulipristal
description: Patients will take 15mg every other day, or every 4 days per week.
arm group label: Ulipristal
other name: Ulipristal Acetate
other name: Ella
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Serdar Bulun
role: Principal Investigator
affiliation: Northwestern University, Northwestern Memorial Hopsital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Serdar Bulun
investigator title: Chair, Department of Obstetrics & Gynecology
mesh term: Endometriosis
mesh term: Pelvic Pain
mesh term: Ulipristal acetate
sharing ipd: No
submitted: April 18, 2019
returned: May 10, 2019
submitted: September 26, 2022
returned: October 21, 2022