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A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules

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ClinicalTrials.gov Identifier: NCT04464187
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : February 27, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:

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.


Condition or disease
Endometriosis Uterine Fibrioids

Study Design
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Study Type : Observational
Estimated Enrollment : 584 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix
Actual Study Start Date : January 6, 2022
Estimated Primary Completion Date : January 23, 2029
Estimated Study Completion Date : January 23, 2029

Resource links provided by the National Library of Medicine

Drug Information available for: Elagolix

Groups and Cohorts
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Group/Cohort
Participants exposed to Elagolix-containing products
Pregnant participants exposed to Elagolix from 14 days after last menstrual period (LMP) or at any point during pregnancy.
Participants not exposed to Elagolix-containing products
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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of major congenital malformations [ Time Frame: Approximately 2 years (1 year post-delivery) ]
    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.


Secondary Outcome Measures :
  1. Rate of minor congenital malformations [ Time Frame: Approximately 2 years (1 year post-delivery) ]
    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.

  2. Rate of spontaneous abortion [ Time Frame: Up to 9 months ]
    Defined as non-deliberate embryonic or fetal death that occurs prior to 20 weeks gestation post-last menstrual period.

  3. Rate of elective or therapeutic pregnancy termination [ Time Frame: Up to 9 months ]
    Rate of elective or therapeutic pregnancy termination.

  4. Rate of stillbirth [ Time Frame: Up to 9 months ]
    Defined as non-deliberate fetal death that occurs at or after 20 weeks gestation but prior to delivery.

  5. Rate of preterm birth [ Time Frame: Up to 9 months ]
    Defined as live birth prior to 37 weeks gestation as counted from last menstrual period or based on ultrasound used for conception dating.

  6. Rate of maternal placental issues [ Time Frame: Up to 9 months ]
    Rate of maternal placental issues, including placenta previa and placental abruption.

  7. Rate of small for gestation age infants [ Time Frame: Up to 9 months ]
    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.

  8. Rate of postnatal growth deficiency or failure to thrive [ Time Frame: Approximately 2 years (1 year post-delivery) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with or without exposure to Orilissa for their endometriosis or other indications for prescribing of the medication.
Criteria

Inclusion Criteria:

Participants exposed to Elagolix:

  • Currently pregnant.
  • Documentation that the participant was exposed to elagolix-containing product from 14 days after last menstrual period (LMP) or at any time during pregnancy.
  • Consents to participate in the study. If the participant is a minor, consent will be obtained according to local regulations.

Internal Comparator:

  • Currently pregnant with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of elagolix-containing product.
  • Documentation that the participant was not exposed to elagolix-containing product from 14 days after LMP or any time during pregnancy.
  • Consents to participate in the study. If the participant is a minor, consent will be obtained according to local regulations.

Exclusion Criteria:

-None.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464187


Contacts
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Contact: Bloom Pregnancy Call Center 18337827241 bloompregnancyregistry@iqvia.com

Locations
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United States, North Carolina
Iqvia /Id# 240918 Recruiting
Durham, North Carolina, United States, 27703-8426
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Additional Information:

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04464187    
Other Study ID Numbers: P18-954
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: February 27, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Endometriosis
Pregnancy
Orlissa
 Elagolix
Uterine fibriods
Oriahnn
Additional relevant MeSH terms:
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Endometriosis