EndometriosisNCT04464187
A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules
An observational study of Endometriosis and Uterine Fibrioids, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometriosis, Uterine Fibrioids
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to 11 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women with or without exposure to Orilissa for their endometriosis or other indications for prescribing of the medication.
Who may be able to join
- 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.
Who cannot join
- -None.
Trial locations and contacts
1 site in 1 country.
United States1 site
Iqvia /Id# 240918
Durham, North Carolina, 27703-8426
About this study
Official title: Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix
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.
Read more
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/.
- Conditions
- Endometriosis, Uterine Fibrioids
- Keywords
- Endometriosis, Pregnancy, Orlissa, Elagolix, Uterine fibriods, Oriahnn
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants exposed to Elagolix-containing products | Pregnant participants exposed to Elagolix from 14 days after last menstrual period (LMP) or at any point during pregnancy. | |
| Participants not exposed to Elagolix-containing products | Pregnant participants with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of Elagolix-containing products not exposed to Elagolix from 14 days after LMP or at any point during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major congenital malformations
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.
Measured: Approximately 2 years (1 year post-delivery)
Secondary outcomes (8)
Rate of minor congenital malformations
Defined as a defect that occurs infrequently in the population but that has neither cosmetic nor functional significance to the child and is identified in the infant up to 1 year of age.
Measured: Approximately 2 years (1 year post-delivery)
Rate of spontaneous abortion
Defined as non-deliberate embryonic or fetal death that occurs prior to 20 weeks gestation post-last menstrual period.
Measured: Up to 9 months
Rate of elective or therapeutic pregnancy termination
Rate of elective or therapeutic pregnancy termination.
Measured: Up to 9 months
Rate of stillbirth
Defined as non-deliberate fetal death that occurs at or after 20 weeks gestation but prior to delivery.
Measured: Up to 9 months
Rate of preterm birth
Defined as live birth prior to 37 weeks gestation as counted from last menstrual period or based on ultrasound used for conception dating.
Measured: Up to 9 months
Rate of maternal placental issues
Rate of maternal placental issues, including placenta previa and placental abruption.
Measured: Up to 9 months
Rate of small for gestation age infants
Defined as birth size (weight, length, or head circumference) less than or equal to the 10th percentile for sex and gestational age using National Center for Health Statistics (NCHS) pediatric growth curves for full-term infants. Prenatal growth curves specific to preterm infants will be used for premature infants.
Measured: Up to 9 months
Rate of postnatal growth deficiency or failure to thrive
Rate of postnatal growth deficiency or failure to thrive as diagnosed by his/her treating physician using criteria such as a significant weight or weight-for-height deceleration.
Measured: Approximately 2 years (1 year post-delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start6 Jan 2022
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464187
- Sponsor's protocol ID
- P18-954
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2020
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix
- ClinicalTrials.gov ID
- NCT04464187
- Acronym / sponsor ID
- P18-954
- Conditions
- Endometriosis, Uterine Fibrioids
- Keywords
- Endometriosis, Pregnancy, Orlissa, Elagolix, Uterine fibriods, Oriahnn
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Company Decision
- Enrolment
- 173 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants exposed to Elagolix-containing products | – | –Pregnant participants exposed to Elagolix from 14 days after last menstrual period (LMP) or at any point during pregnancy. |
| Participants not exposed to Elagolix-containing products | – | –Pregnant participants with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of Elagolix-containing products not exposed to Elagolix from 14 days after LMP or at any point during pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with or without exposure to Orilissa for their endometriosis or other indications for prescribing of the medication.
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- -None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of major congenital malformations
Time frame: Approximately 2 years (1 year post-delivery)
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.
8 secondary outcomes
Rate of minor congenital malformations
Time frame: Approximately 2 years (1 year post-delivery)
Rate of spontaneous abortion
Time frame: Up to 9 months
Rate of elective or therapeutic pregnancy termination
Time frame: Up to 9 months
Rate of stillbirth
Time frame: Up to 9 months
Rate of preterm birth
Time frame: Up to 9 months
Rate of maternal placental issues
Time frame: Up to 9 months
Rate of small for gestation age infants
Time frame: Up to 9 months
Rate of postnatal growth deficiency or failure to thrive
Time frame: Approximately 2 years (1 year post-delivery)
Results and safety
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Related Info.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Uterine Fibrioids, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major congenital malformations (time frame: Approximately 2 years (1 year post-delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.