<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/NCT04464187</url>
  </required_header>
  <id_info>
    <org_study_id>P18-954</org_study_id>
    <nct_id>NCT04464187</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules</brief_title>
  <official_title>Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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>
      Orilissa is a drug approved for the management of moderate to severe pain associated with&#xD;
      endometriosis. Oriahnn is approved for heavy menstrual bleeding due to uterine fibroids.&#xD;
      Elagolix-containing products should not be taken by women who are pregnant or suspected to be&#xD;
      pregnant but pregnancies are expected as the medicine does not completely stop ovulation and&#xD;
      women may inadvertently continue taking Elagolix-containing products until their pregnancy is&#xD;
      confirmed.&#xD;
&#xD;
      This study will assess pregnancy outcomes (maternal, fetal, and infant) of participants with&#xD;
      and without exposure to Elagolix-containing products for their endometriosis or other&#xD;
      conditions based on approved indications and prescribing patterns of Elagolix. Around 584&#xD;
      participants will be enrolled (292 participants exposed to Elagolix and 292 without exposure)&#xD;
      in the United States.&#xD;
&#xD;
      Participants will not receive Elagolix-containing products as part of this study but will be&#xD;
      followed for maternal and fetal outcomes up to 1 year after delivery.&#xD;
&#xD;
      There may be a higher burden for participants in this study compared to standard of care.&#xD;
      Participants will be asked to provide additional information by questionnaire during each&#xD;
      trimester of pregnancy, and at 0-6 weeks, 26 weeks, and 1 year after delivery. Contact Bloom&#xD;
      Pregnancy Call Center at 1-833-782-7241 or bloompregnancyregistry@iqvia.com or visit&#xD;
      https://www.bloompregnancyregistry.com/.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 6, 2022</start_date>
  <completion_date type="Anticipated">January 23, 2029</completion_date>
  <primary_completion_date type="Anticipated">January 23, 2029</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of major congenital malformations</measure>
    <time_frame>Approximately 2 years (1 year post-delivery)</time_frame>
    <description>Defined as an abnormality in structural development that is medically or cosmetically significant, present at birth, and persists in postnatal life unless or until repaired.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of minor congenital malformations</measure>
    <time_frame>Approximately 2 years (1 year post-delivery)</time_frame>
    <description>Defined as a defect that occurs infrequently in the population but that has neither cosmetic nor functional significance to the child and is identified in the infant up to 1 year of age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of spontaneous abortion</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Defined as non-deliberate embryonic or fetal death that occurs prior to 20 weeks gestation post-last menstrual period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of elective or therapeutic pregnancy termination</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Rate of elective or therapeutic pregnancy termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of stillbirth</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Defined as non-deliberate fetal death that occurs at or after 20 weeks gestation but prior to delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of preterm birth</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Defined as live birth prior to 37 weeks gestation as counted from last menstrual period or based on ultrasound used for conception dating.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of maternal placental issues</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Rate of maternal placental issues, including placenta previa and placental abruption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of small for gestation age infants</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Defined as birth size (weight, length, or head circumference) less than or equal to the 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) pediatric growth curves for full-term infants. Prenatal growth curves specific to preterm infants will be used for premature infants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of postnatal growth deficiency or failure to thrive</measure>
    <time_frame>Approximately 2 years (1 year post-delivery)</time_frame>
    <description>Rate of postnatal growth deficiency or failure to thrive as diagnosed by his/her treating physician using criteria such as a significant weight or weight-for-height deceleration.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">584</enrollment>
  <condition>Endometriosis</condition>
  <condition>Uterine Fibrioids</condition>
  <arm_group>
    <arm_group_label>Participants exposed to Elagolix-containing products</arm_group_label>
    <description>Pregnant participants exposed to Elagolix from 14 days after last menstrual period (LMP) or at any point during pregnancy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants not exposed to Elagolix-containing products</arm_group_label>
    <description>Pregnant participants with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of Elagolix-containing products not exposed to Elagolix from 14 days after LMP or at any point during pregnancy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women with or without exposure to Orilissa for their endometriosis or other&#xD;
        indications for prescribing of the medication.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants exposed to Elagolix:&#xD;
&#xD;
          -  Currently pregnant.&#xD;
&#xD;
          -  Documentation that the participant was exposed to elagolix-containing product from 14&#xD;
             days after last menstrual period (LMP) or at any time during pregnancy.&#xD;
&#xD;
          -  Consents to participate in the study. If the participant is a minor, consent will be&#xD;
             obtained according to local regulations.&#xD;
&#xD;
        Internal Comparator:&#xD;
&#xD;
          -  Currently pregnant with endometriosis, uterine fibroids, or other conditions based on&#xD;
             approved indications and prescribing patterns of elagolix-containing product.&#xD;
&#xD;
          -  Documentation that the participant was not exposed to elagolix-containing product from&#xD;
             14 days after LMP or any time during pregnancy.&#xD;
&#xD;
          -  Consents to participate in the study. If the participant is a minor, consent will be&#xD;
             obtained according to local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -None.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bloom Pregnancy Call Center</last_name>
    <phone>18337827241</phone>
    <email>bloompregnancyregistry@iqvia.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Iqvia /Id# 240918</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27703-8426</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bloompregnancyregistry.com/</url>
    <description>Related Info.</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endometriosis</keyword>
  <keyword>Pregnancy</keyword>
  <keyword>Orlissa</keyword>
  <keyword>Elagolix</keyword>
  <keyword>Uterine fibriods</keyword>
  <keyword>Oriahnn</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_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/NCT04464187
org study id: P18-954
nct id: NCT04464187
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Orilissa is a drug approved for the management of moderate to severe pain associated with
      endometriosis. Oriahnn is approved for heavy menstrual bleeding due to uterine fibroids.
      Elagolix-containing products should not be taken by women who are pregnant or suspected to be
      pregnant but pregnancies are expected as the medicine does not completely stop ovulation and
      women may inadvertently continue taking Elagolix-containing products until their pregnancy is
      confirmed.

      This study will assess pregnancy outcomes (maternal, fetal, and infant) of participants with
      and without exposure to Elagolix-containing products for their endometriosis or other
      conditions based on approved indications and prescribing patterns of Elagolix. Around 584
      participants will be enrolled (292 participants exposed to Elagolix and 292 without exposure)
      in the United States.

      Participants will not receive Elagolix-containing products as part of this study but will be
      followed for maternal and fetal outcomes up to 1 year after delivery.

      There may be a higher burden for participants in this study compared to standard of care.
      Participants will be asked to provide additional information by questionnaire during each
      trimester of pregnancy, and at 0-6 weeks, 26 weeks, and 1 year after delivery. Contact Bloom
      Pregnancy Call Center at 1-833-782-7241 or bloompregnancyregistry@iqvia.com or visit
      https://www.bloompregnancyregistry.com/.
observational model: Cohort
time perspective: Prospective
measure: Rate of major congenital malformations
time frame: Approximately 2 years (1 year post-delivery)
description: Defined as an abnormality in structural development that is medically or cosmetically significant, present at birth, and persists in postnatal life unless or until repaired.
measure: Rate of minor congenital malformations
time frame: Approximately 2 years (1 year post-delivery)
description: Defined as a defect that occurs infrequently in the population but that has neither cosmetic nor functional significance to the child and is identified in the infant up to 1 year of age.
measure: Rate of spontaneous abortion
time frame: Up to 9 months
description: Defined as non-deliberate embryonic or fetal death that occurs prior to 20 weeks gestation post-last menstrual period.
measure: Rate of elective or therapeutic pregnancy termination
time frame: Up to 9 months
description: Rate of elective or therapeutic pregnancy termination.
measure: Rate of stillbirth
time frame: Up to 9 months
description: Defined as non-deliberate fetal death that occurs at or after 20 weeks gestation but prior to delivery.
measure: Rate of preterm birth
time frame: Up to 9 months
description: Defined as live birth prior to 37 weeks gestation as counted from last menstrual period or based on ultrasound used for conception dating.
measure: Rate of maternal placental issues
time frame: Up to 9 months
description: Rate of maternal placental issues, including placenta previa and placental abruption.
measure: Rate of small for gestation age infants
time frame: Up to 9 months
description: Defined as birth size (weight, length, or head circumference) less than or equal to the 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) pediatric growth curves for full-term infants. Prenatal growth curves specific to preterm infants will be used for premature infants.
measure: Rate of postnatal growth deficiency or failure to thrive
time frame: Approximately 2 years (1 year post-delivery)
description: Rate of postnatal growth deficiency or failure to thrive as diagnosed by his/her treating physician using criteria such as a significant weight or weight-for-height deceleration.
arm group label: Participants exposed to Elagolix-containing products
description: Pregnant participants exposed to Elagolix from 14 days after last menstrual period (LMP) or at any point during pregnancy.
arm group label: Participants not exposed to Elagolix-containing products
description: Pregnant participants with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of Elagolix-containing products not exposed to Elagolix from 14 days after LMP or at any point during pregnancy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
last name: Bloom Pregnancy Call Center
phone: 18337827241
email: bloompregnancyregistry@iqvia.com
facility: 
status: Recruiting
country: United States
url: https://www.bloompregnancyregistry.com/
description: Related Info.
responsible party type: Sponsor
mesh term: Endometriosis
sharing ipd: Undecided