NCT04464187Terminated
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Reason given: Company Decision
Brief summary (registry, in English)
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 or visit https://www.bloompregnancyregistry.com/.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 173 (actual)
- First submitted
- 7 Jul 2020
- Start date
- 6 Jan 2022
- Primary completion date
- 11 Jul 2025
- Lead sponsor
- AbbVie
- Diseases
- Endometriosis
- NCT number
- NCT04464187
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- -None.
Who the study is looking for
- 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.
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Iqvia /Id# 240918 | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.