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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464187
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date July 7, 2020
First Posted Date July 9, 2020
Last Update Posted Date November 10, 2022
Actual Study Start Date January 6, 2022
Estimated Primary Completion Date January 16, 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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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 16, 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: Susan Goon +1 (862) 261-7529 susan.goon@abbvie.com
Listed Location Countries United States
Removed Location Countries  
 
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 November 2022