MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

Conditions
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Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk

Intervention / Treatment
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* Drug: Relugolix + Estradiol + Norethindrone Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed Cohort<br>Pregnant women with conditions for which relugolix combination therapy is prescribed, who are exposed to relugolix combination therapy at any time during pregnancy | Drug: Relugolix + Estradiol + Norethindrone Acetate<br>* Relugolix combination therapy (relugolix 40 mg; estradiol 1 mg; norethindrone 0.5 mg)<br>* Other names: MYFEMBREE;|
| Unexposed Cohort<br>Pregnant women with conditions for which relugolix combination therapy could be prescribed, who are not exposed to relugolix combination therapy at any time during pregnancy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Congenital Malformation (MCM) | Comparison of rate of MCM between cohorts | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous abortion (SAB) | Comparison of rate of SABs between cohorts | Up to 5 years | 
| Stillbirth | Comparison of rate of stillbirths between cohorts | Up to 5 years | 
| Preterm birth | Comparison of rate of preterm births between cohorts | Up to 5 years | 
| Small for gestational age (SGA) | Comparison of rate of SGA between cohorts | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relugolix, Uterine Fibroids, Endometriosis, Pregnancy