The BLOOM Pregnancy Registry (NCT04464187), sponsored by AbbVie Inc., was created to collect information about the possible effects of elagolix-containing medications, like ORILISSA® (elagolix tablets), on pregnancy, delivery, and the health of infants. Information from the following 2 groups will be evaluated:
- women who were exposed to ORILISSA during early pregnancy
- women who were not taking ORILISSA when they became pregnant, but who have endometriosis.
If you have a patient who is interested in learning more about the registry and agrees to be contacted by a registry representative, please register their interest now using the button below.
Register a Patient View eligibility criteria
Important Safety Information: ORILISSA should not be taken by women who are pregnant or trying to become pregnant as they may increase the risk of early pregnancy loss. Women who become pregnant while taking a medication containing ORILISSA should stop taking it right away and call their healthcare provider.
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About the BLOOM Pregnancy Registry
The BLOOM Pregnancy Registry was established to help determine the frequency of major congenital malformations at birth and through the first year of life in infants of women who were exposed to an elagolix-containing medication during pregnancy.
Pregnancy is something that many women with endometriosis may have thought about or experienced, because endometriosis often first affects women when they are of childbearing age1.
Many of the available treatments for endometriosis, ORILISSA® (elagolix tablets) included, are not approved for use during pregnancy.2 Often, the effect of these medications or treatments on pregnancy, or the health of an unborn infant, is not known because pregnant women are often excluded from research studies. It is hoped that this registry will help doctors to better understand if ORILISSA has any effect on pregnancy, delivery, or the health of infants, since women may have taken ORILISSA before realizing they were pregnant.
ORILISSA is contraindicated in women who are pregnant. Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss.
Information about this registry is available at clincialtrials.gov (NCT04464187). You may also search for ORILISSA on the US Food and Drug Administration (FDA) pregnancy exposure registries website.
References
- U.S. Department of Heath and Human Services, Office on Women’s Health. Endometriosis. https://www.womenshealth.gov/a-z-topics/endometriosis. Accessed 03 May 2022.
- ORILISSA® (elagolix tablets) Prescribing Information.
Have questions?
Have questions?
Please call a registry representative at 1-(833)-782-7241 for more information.
Eligibility Criteria?
Your patient is potentially eligible to participate in this registry if she is pregnant, and:
What are my responsibilities as a healthcare provider (HCP)?
As the HCP of a study participant, you will be contacted:
- When your patient enrolls
- During your patient’s second trimester (at approximately 21 weeks)
- About 4 weeks after your patient’s delivery
As the HCP of a participant’s infant, you will be contacted when the infant is about:
- 6 months old
- 12 months old
At each contact point, you or your staff will be requested to:
The worksheets should take no more than 10–15 minutes to complete. The information requested will be obtained from your patient’s medical record.
What will my patient have to do once she is enrolled?
If your patient consents and is eligible to take part, she will be asked to share information on her health, lifestyle, and pregnancy, and will be contacted:
- at enrollment
- during each trimester
- within 4 weeks of her estimated date of delivery, following her infant’s birth
- when her infant is 6 and 12 months old
At each time point, your patient will be asked to confirm her contact information.
Will I be compensated for my time as a healthcare provider?
You will not be compensated for your time. However, the information that you provide will help us learn more about the possible effects of ORILISSA on pregnancy, delivery, and the health of infants whose mothers were exposed to ORILISSA during pregnancy. In the future, it is hoped that the results of the registry will help you and your colleagues, along with your patients, make more informed decisions about the use of ORILISSA.
How will the registry data be collected and stored?
Women who join the BLOOM Pregnancy Registry will provide a release of information form that will allow the Registry Coordinating Center to contact their healthcare providers. These contacts are necessary to obtain information on the participant’s pregnancy and delivery, and/or the health of her infant.
The Registry Coordinating Center will collect the information provided by the patient along with the forms submitted from the healthcare providers. The data collected from all parties will be kept in a secure database as per our privacy policy. The health information of the patient will be kept anonymous and any identifying information will not be used.
Resources
When asked by the Registry Coordinating Center (RCC), please download, complete, and submit the applicable worksheet for your patient by fax 1-(833)-318-1043 or email to BloomPregnancyRegistry@IQVIA.com .
How can I register my patient?
Contact the Registry Coordinating Center (RCC) at 1-(833)-782-7241 for registration information
Assist your patient in filling out the contact form on the website or register your patient’s interest with their authorization by clicking the link below
Inform your patient that she may register by calling 1-(833)-782-7241
For the latest important safety information, please refer to the full Prescribing Information.