Evaluating pregnancy outcomes in women treated with Elagolix
Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix
This study is trying to see how pregnancy outcomes differ for women who have taken Elagolix for endometriosis compared to those who haven't taken the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 584 (estimated) |
| Sex | Female |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04464187 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess pregnancy outcomes in women who have been treated with Elagolix, a medication used for managing endometriosis and uterine fibroids. The study will enroll approximately 584 participants, with half having been exposed to Elagolix and the other half not exposed. Participants will be followed to evaluate maternal, fetal, and infant outcomes during their pregnancies. The study will provide insights into the effects of Elagolix on pregnancy, considering that the drug does not completely prevent ovulation.
Who should consider this trial
Good fit: Ideal candidates include currently pregnant women who have either been treated with Elagolix or have endometriosis or uterine fibroids without prior exposure to the drug.
Not a fit: Patients who are not currently pregnant or those who have not been treated with Elagolix may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety and outcomes of pregnancies in women treated with Elagolix.
How similar studies have performed: While there have been studies on Elagolix for endometriosis, this specific focus on pregnancy outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- Iqvia /Id# 240918 — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Bloom Pregnancy Call Center
- Email: bloompregnancyregistry@iqvia.com
- Phone: 18337827241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.