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

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

Tracking Information

• First Submitted Date: July 7, 2020
• First Posted Date: July 9, 2020
• Last Update Posted Date: February 27, 2023
• Actual Study Start Date: January 6, 2022
• Estimated Primary Completion Date: January 23, 2029 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 7, 2020)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 7, 2020)

• 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.
• 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.
• Rate of elective or therapeutic pregnancy termination [ Time Frame: Up to 9 months ]
  Rate of elective or therapeutic pregnancy termination.
• 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.
• 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.
• Rate of maternal placental issues [ Time Frame: Up to 9 months ]
  Rate of maternal placental issues, including placenta previa and placental abruption.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules
• Official Title: Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Endometriosis
• Uterine Fibrioids

• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 7, 2020): 584
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 23, 2029
• Estimated Primary Completion Date: January 23, 2029 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04464187
• Other Study ID Numbers: P18-954
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: AbbVie
• Original Responsible Party: Same as current
• Current Study Sponsor: AbbVie
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ABBVIE INC.; AbbVie

• PRS Account: AbbVie
• Verification Date: February 2023