Clinical trial NCT04464187: A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules
Official title: Prospective Registry to Evaluate Pregnancy Outcomes in Women Treated With Elagolix
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Uterine Fibrioids
Keywords: Endometriosis
Pregnancy
Orlissa
Elagolix
Uterine fibriods
Oriahnn
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-07-09
Enrollment: 584
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with or without exposure to Orilissa for their endometriosis or other indications for prescribing of the medication.

Brief 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/.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

-None.

Primary outcomes:
measure: Rate of major congenital malformations
timeFrame: Approximately 2 years (1 year post-delivery)
Secondary outcomes:
measure: Rate of minor congenital malformations
timeFrame: Approximately 2 years (1 year post-delivery)
measure: Rate of spontaneous abortion
timeFrame: Up to 9 months
measure: Rate of elective or therapeutic pregnancy termination
timeFrame: Up to 9 months
measure: Rate of stillbirth
timeFrame: Up to 9 months
measure: Rate of preterm birth
timeFrame: Up to 9 months
measure: Rate of maternal placental issues
timeFrame: Up to 9 months
measure: Rate of small for gestation age infants
timeFrame: Up to 9 months
measure: Rate of postnatal growth deficiency or failure to thrive
timeFrame: Approximately 2 years (1 year post-delivery)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Iqvia /Id# 240918
state: North Carolina
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: