Abbvie ((ABBV)) announced an update on their ongoing clinical study.
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Study Overview: AbbVie recently updated its clinical study titled ‘Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix.’ This study aims to assess maternal, fetal, and infant outcomes in women exposed to Elagolix, a drug used for endometriosis and uterine fibroids, compared to those not exposed. The study’s significance lies in understanding the potential risks associated with Elagolix during pregnancy.
Intervention/Treatment: The study examines the effects of Elagolix, marketed as Orilissa for endometriosis and Oriahnn for uterine fibroids, on pregnancy outcomes. Elagolix is not administered as part of the study; rather, it observes outcomes in women who have been exposed to the drug.
Study Design: This observational study follows a cohort model with a prospective time perspective. It involves two groups: those exposed to Elagolix and those not exposed. Participants provide information through questionnaires during pregnancy and up to one year post-delivery.
Study Timeline: The study began on July 7, 2020, and was last updated on September 9, 2025. It has been terminated, indicating that it will not continue to completion. These dates are crucial for understanding the study’s progress and current status.
Market Implications: The termination of this study could impact AbbVie’s stock performance and investor sentiment, as it raises questions about the safety profile of Elagolix during pregnancy. Competitors in the women’s health sector may see this as an opportunity to strengthen their market position.
The study is currently terminated, with further details available on the ClinicalTrials portal.
