Clinical trial NCT05739136: MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
Official title: MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy Related
Pregnancy Complications
Pregnancy, High Risk
Keywords: Relugolix
Uterine Fibroids
Endometriosis
Pregnancy
Lead sponsor: Sumitomo Pharma Switzerland GmbH
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 530
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include 2 cohorts: The exposed cohort will include pregnant women with conditions for which relugolix combination therapy is prescribed and who are exposed to relugolix combination therapy at any time during pregnancy. The unexposed cohort will include pregnant women with conditions for which relugolix combination therapy could be prescribed and who are not exposed to relugolix combination therapy at any time during pregnancy.

Brief summary: This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.

Detailed description: The study will identify pregnant women exposed to relugolix combination therapy during pregnancy from a United States (US) administrative claims database. The primary outcome measure is major congenital malformations (MCMs) among linked live births. Secondary outcome measures include spontaneous abortion (SAB), stillbirth, small size for gestational age (SGA), and preterm birth. Infants of pregnancies with linked live birth outcomes will be followed up to 12 months of age for identification of MCMs. Anticipated enrollment is 530 live births.

Eligibility criteria: Inclusion Criteria:

* Woman ≥ 18 and ≤ 50 years of age at time of conception
* Diagnosis of a condition for which relugolix combination therapy is prescribed (diagnosis captured at any time prior to the estimated date of conception)

Cohort 1

* Exposure to relugolix combination therapy at any time during pregnancy

Cohort 2

* No exposure to relugolix combination therapy at any time after the estimated date of conception (during pregnancy)

Exclusion Criteria:

* Exposure to known teratogens during pregnancy
* \< 6 months of continuous healthcare coverage immediately prior to date of conception

Primary outcomes:
measure: Major Congenital Malformation (MCM)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Spontaneous abortion (SAB)
timeFrame: Up to 5 years
measure: Stillbirth
timeFrame: Up to 5 years
measure: Preterm birth
timeFrame: Up to 5 years
measure: Small for gestational age (SGA)
timeFrame: Up to 5 years
Other outcomes:
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