NCT04464187

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

Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 173 (actual)
• Sponsor: AbbVie · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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. Contact Bloom Pregnancy Call Center at 1-833-782-7241 or [e-mail] or visit https://www.bloompregnancyregistry.com/.

Conditions

• Endometriosis
• Uterine Fibrioids

Timeline

• Start date: 2022-01-06
• Primary completion: 2025-07-11
• Completion: 2025-07-11
• First posted: 2020-07-09
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States