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

Launched by ABBVIE · Jul 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called Elagolix on pregnancy outcomes for women who have conditions like endometriosis or uterine fibroids. The researchers want to understand how pregnancies go for women who have taken Elagolix compared to those who haven't. The study will involve about 584 women in the United States, with half of the participants having been exposed to Elagolix and the other half not having used the medication. It's important to know that Elagolix should not be taken by pregnant women, but since it does not completely stop ovulation, some women might still get pregnant while using it.

To be eligible for the study, women must currently be pregnant. Those in the first group must have taken Elagolix at some point during their pregnancy, while those in the second group must not have taken it at all. Participants will be asked to fill out questionnaires during their pregnancy and for a year after giving birth to help gather information about both the mothers and the babies. While this study may require more participation than standard care, it aims to provide valuable insights into the safety of Elagolix during pregnancy. If you have questions or want more information, you can reach out to the Bloom Pregnancy Call Center or visit their website.

Gender

FEMALE

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.