Status:
TERMINATED
A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules
Lead Sponsor:
AbbVie
Conditions:
Endometriosis
Uterine Fibrioids
Eligibility:
FEMALE
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 p...
Eligibility Criteria
Inclusion
- 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
- None.
Key Trial Info
Start Date :
January 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 11 2025
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT04464187
Start Date
January 6 2022
End Date
July 11 2025
Last Update
September 15 2025
Active Locations (1)
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1
Iqvia /Id# 240918
Durham, North Carolina, United States, 27703-8426