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NCT04464187 · ClinicalTrials.gov registry record
A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules
A clinical trial, sponsored by AbbVie.
- Terminated
- Registry status
- 173
- Enrollment target
NCT04464187: Clinical Trial study, sponsored by AbbVie.
NCT04464187 is a clinical trial that was terminated before completion, run by AbbVie. The registered enrollment target is 173 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04464187 was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- 173 participants
- Enrollment target
Study 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 bloompregnancyregistry@iqvia.com or visit https://www.bloompregnancyregistry.com/.
Primary Outcome
Defined as an abnormality in structural development that is medically or cosmetically significant, present at birth, and persists in postnatal life unless or until repaired.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2022-01-06 |
| Est. Completion | 2025-07-11 |
Why NCT04464187 stopped before completion
NCT04464187 is an observational study that tracks outcomes without assigning an intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04464187 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04464187 about?
NCT04464187 is a clinical study titled "A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules". 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 ar...
What is the current status of trial NCT04464187?
This trial is currently terminated. The enrollment target is 173 participants. The study started on 2022-01-06. Estimated completion is 2025-07-11.
Who is sponsoring clinical trial NCT04464187?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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